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Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease (STICH)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00023595
First received: September 11, 2001
Last updated: July 20, 2017
Last verified: July 2017
September 11, 2001
July 20, 2017
January 2002
November 2015   (Final data collection date for primary outcome measure)
  • H01: All Cause Mortality [ Time Frame: 5 years post randomization ]
  • H01: All Cause Mortality [ Time Frame: 10 years post randomization ]
  • H02: All-cause Mortality or Cardiovascular Hospitalization [ Time Frame: 5 years post randomization ]
Not Provided
Complete list of historical versions of study NCT00023595 on ClinicalTrials.gov Archive Site
  • H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology). [ Time Frame: 10 years post randomization ]
  • H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology). [ Time Frame: 5 years post randomization ]
  • H01: Mortality or Cardiovascular Hospitalization [ Time Frame: up to 5 years post randomization ]
  • H01: Mortality or Cardiovascular Hospitalization [ Time Frame: up to 10 years post randomization ]
  • H02: All-cause Mortality [ Time Frame: up to 5 years ]
  • H01: All-cause Mortality Within 30 Days After Randomization [ Time Frame: 30 days post randomization ]
  • H02: All-cause Mortality Within 30 Days After Randomization [ Time Frame: 30 days post randomization ]
  • H01: All-cause Mortality or Heart-failure Hospitalization [ Time Frame: 5 years post randomization ]
  • H02: All-cause Mortality or Heart-failure Hospitalization [ Time Frame: 5 years post randomization ]
  • H01: All-cause Mortality or Heart-failure Hospitalization [ Time Frame: 10 years post randomization ]
  • H01: Heart Failure Hospitalization [ Time Frame: 5 years post randomization ]
  • H02: Heart Failure Hospitalization [ Time Frame: 5 years post randomization ]
  • H01: Heart Failure Hospitalization [ Time Frame: 10 years post randomization ]
  • H01: Cardiac Procedure: Heart Transplant [ Time Frame: 5 years post randomization ]
  • H02: Cardiac Procedure: Heart Transplant [ Time Frame: 5 years post randomization ]
  • H01: Cardiac Procedure: Heart Transplant [ Time Frame: 10 years post randomization ]
  • H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD) [ Time Frame: 5 years post randomization ]
  • H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD) [ Time Frame: 5 years post randomization ]
  • H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD) [ Time Frame: 10 years post randomization ]
  • H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) [ Time Frame: 5 years post randomization ]
  • H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) [ Time Frame: 5 years post randomization ]
  • H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) [ Time Frame: 10 years post randomization ]
  • H01: Stroke [ Time Frame: 5 years post randomization ]
  • H01: Stroke [ Time Frame: 10 years post randomization ]
  • H02: Stroke [ Time Frame: 5 years post randomization ]
  • H01: All-cause Mortality or Revascularization (CABG or PCI) [ Time Frame: 5 years post randomization ]
    CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
  • H02: All-cause Mortality or Revascularization (CABG or PCI) [ Time Frame: 5 years post randomization ]
    CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
  • H01: All-cause Mortality or Revascularization (CABG or PCI) [ Time Frame: 10 years post randomization ]
    CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
  • H01: All-cause Mortality, Heart Transplant or LVAD [ Time Frame: 5 years post randomization ]
    LVAD=Left Ventricular Assist Device
  • H02: All-cause Mortality, Heart Transplant or LVAD [ Time Frame: 5 years post randomization ]
  • H01: All-cause Mortality, Heart Transplant or LVAD [ Time Frame: 10 years post randomization ]
    LVAD=Left Ventricular Assist Device
  • H01: All-cause (Unplanned and Elective) Hospitalization [ Time Frame: 5 years post randomization ]
  • H02: All-cause (Unplanned and Elective) Hospitalization [ Time Frame: 5 years post randomization ]
  • H01: All-cause (Unplanned and Elective) Hospitalization [ Time Frame: 10 years post randomization ]
  • H01: 6 Minute Walk Distance [ Time Frame: From randomization to 24 month follow-up ]
  • H02: 6 Minute Walk Distance [ Time Frame: From randomization to 24 month follow-up ]
  • H01: Exercise Duration [ Time Frame: From randomization to 24 months follow-up ]
    Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test
  • H02: Exercise Duration [ Time Frame: From randomization to 24 months follow-up ]
    Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test
  • H01: LVEF by ECHO Core Lab During Follow-up [ Time Frame: From randomization to 24 months follow-up ]
    Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab
  • H02: LVEF by ECHO Core Lab During Follow-up [ Time Frame: From randomization to 24 months follow-up ]
    Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab
  • H01: LVEF by RN Core Lab During Follow-up [ Time Frame: From randomization to 24 months follow-up ]
    Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.
  • H02: LVEF by RN Core Lab During Follow-up [ Time Frame: From randomization to 24 months follow-up ]
    Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.
  • H01: LVEF by CMR Core Lab During Follow-up [ Time Frame: From randomization to 24 months follow-up ]
    Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.
  • H02: LVEF by CMR Core Lab During Follow-up [ Time Frame: From randomization to 24 months follow-up ]
    Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.
  • H01: B-type Natriuretic Peptide (BNP) [ Time Frame: From randomization to 24 months follow-up ]
    B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up
  • H02: B-type Natriuretic Peptide (BNP) [ Time Frame: From randomization to 24 months follow-up ]
    B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up
  • H01: SF-36 Mental Health Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    Short Form 36 Health Status Questionnaire (SF-36) Mental Health Subscale: These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
  • H02: SF-36 Mental Health Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
  • H01:SF-36 Role Physical Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
  • H02: SF-36 Role Physical Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
  • H01:SF-36 Role Emotional Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
  • H02: SF-36 Role Emotional Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
  • H01:SF-36 Social Functioning Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 2 items assess the limitations on social activities with others. Response choices range from "Extremely" or "All of the time" (1) to "Not at all" or "None of the time" (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
  • H02: SF-36 Social Functioning Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 2 items assess the limitations on social activities with others. Response choices range from "Extremely" or "All of the time" (1) to "Not at all" or "None of the time" (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
  • H01:SF-36 Vitality Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 4 items assess energy level and fatigue. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
  • H02: SF-36 Vitality Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 4 items assess energy level and fatigue. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
  • H01:SF-12 Physical Component Summary (PCS) Scale [ Time Frame: From enrollment to 3-year follow-up ]
    Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "physical" regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "physical" constant from the scoring table to the sum of the 35 products.
  • H02: SF-12 Physical Component Summary (PCS) Scale [ Time Frame: From enrollment to 3-year follow-up ]
    Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "physical" regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "physical" constant from the scoring table to the sum of the 35 products.
  • H01: SF-12 Mental Component Summary (MCS) Scale [ Time Frame: From enrollment to 3-year follow-up ]
    Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "mental" regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "mental" constant from the scoring table to the sum of the 35 products.
  • H02: SF-12 Mental Component Summary (MCS) Scale [ Time Frame: From enrollment to 3-year follow-up ]
    Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "mental" regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "mental" constant from the scoring table to the sum of the 35 products.
  • H01: KCCQ Physical Limitation Scale [ Time Frame: From enrollment to 3-year follow-up ]

    Kansas City Cardiomyopathy Questionnaire (KCCQ)Physical Limitation Scale: These 6 items assess ability to perform various activities of daily living. Response choices range from "Extremely limited" (1) to "Not at all limited" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

  • H02: KCCQ Physical Limitation Scale [ Time Frame: From enrollment to 3-year follow-up ]
    These 6 items assess ability to perform various activities of daily living. Response choices range from "Extremely limited" (1) to "Not at all limited" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
  • H01: KCCQ Symptom Stability [ Time Frame: From enrollment to 3-year follow-up ]

    This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from "Much worse" (1) to "Much better" (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome.

  • H02: KCCQ Symptom Stability [ Time Frame: From enrollment to 3-year follow-up ]
    This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from "Much worse" (1) to "Much better" (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome.
  • H01: KCCQ Symptom Frequency [ Time Frame: From enrollment to 3-year follow-up ]

    These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from "Every morning" or "Every night" or "All of the time" (1) to "Never over the past 2 weeks" (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

  • H02: KCCQ Symptom Frequency [ Time Frame: From enrollment to 3-year follow-up ]
    These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from "Every morning" or "Every night" or "All of the time" (1) to "Never over the past 2 weeks" (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
  • H01: KCCQ Symptom Burden [ Time Frame: From enrollment to 3-year follow-up ]
    These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from "extremely bothersome" (1) to "Not at all bothersome" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
  • H02: KCCQ Symptom Burden [ Time Frame: From enrollment to 3-year follow-up ]
    These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from "extremely bothersome" (1) to "Not at all bothersome" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
  • H01: KCCQ Total Symptoms [ Time Frame: From enrollment to 3-year follow-up ]

    This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

  • H02: KCCQ Total Symptoms [ Time Frame: From enrollment to 3-year follow-up ]
    This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
  • H01: KCCQ Quality-of-Life Scale [ Time Frame: From enrollment to 3-year follow-up ]

    These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

  • H02: KCCQ Quality-of-Life Scale [ Time Frame: From enrollment to 3-year follow-up ]
    These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
  • H01: KCCQ Social Limitation [ Time Frame: From enrollment to 3-year follow-up ]

    These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from "Severely limited" (1) to "Did not limit at all" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

  • H02: KCCQ Social Limitation [ Time Frame: From enrollment to 3-year follow-up ]
    These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from "Severely limited" (1) to "Did not limit at all" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
  • H01: KCCQ Clinical Summary Score [ Time Frame: From enrollment to 3-year follow-up ]

    This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

  • H02: KCCQ Clinical Summary Score [ Time Frame: From enrollment to 3-year follow-up ]
    This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
  • H01: KCCQ Overall Summary Score [ Time Frame: From enrollment to 3-year follow-up ]

    This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

  • H02: KCCQ Overall Summary Score [ Time Frame: From enrollment to 3-year follow-up ]
    This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
  • H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale [ Time Frame: From enrollment to 3-year follow-up ]

    These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from "4 or more times a day" (1) to "None" (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina.

  • H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from "4 or more times a day" (1) to "None" (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina.
  • H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale [ Time Frame: From enrollment to 3-year follow-up ]

    This item assesses the change in chest pain over the last 4 weeks. Response choices range from "Much more often" (1) to "None" (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina.

  • H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    This item assesses the change in chest pain over the last 4 weeks. Response choices range from "Much more often" (1) to "None" (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina.
  • H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale [ Time Frame: From enrollment to 3-year follow-up ]

    These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes.

  • H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes.
  • H01: EQ-5D Visual Analog Scale [ Time Frame: From enrollment to 3-year follow-up ]

    Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D): This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health.

  • H02: EQ-5D Visual Analog Scale [ Time Frame: From enrollment to 3-year follow-up ]
    This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health.
  • H01: EQ-5D Health Status Index Score [ Time Frame: From enrollment to 3-year follow-up ]

    This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are "No problems" (1), "Moderate problems" (2), or "Extreme problems" (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. These scores were multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale.

  • H02: EQ-5D Health Status Index Score [ Time Frame: From enrollment to 3-year follow-up ]
    This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are "No problems" (1), "Moderate problems" (2), or "Extreme problems" (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. (These scores can be multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale.)
  • H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale [ Time Frame: From enrollment to 3-year follow-up ]

    These 20 items assess depressive symptomatology, and responses choices range from "Rarely or none of the time" (0) to "Most or all of the time" (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high.

  • H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale [ Time Frame: From enrollment to 3-year follow-up ]
    These 20 items assess depressive symptomatology, and responses choices range from "Rarely or none of the time" (0) to "Most or all of the time" (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high.
  • H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale [ Time Frame: From enrollment to 3-year follow-up ]

    These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.

  • H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.
  • H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale [ Time Frame: From enrollment to 3-year follow-up ]

    These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.

  • H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.
  • H01: General Health Rating Scale [ Time Frame: From enrollment to 3-year follow-up ]

    This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health.

  • H02: General Health Rating Scale [ Time Frame: From enrollment to 3-year follow-up ]
    This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health.
  • H01: Cost of Care [ Time Frame: index hospital admission ]
    Hospital costs and physician fees for US patients
  • H02: Cost of Care [ Time Frame: index hospital admission ]
    Hospital costs and physician fees for US patients
Not Provided
Not Provided
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Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease
Surgical Treatment for Ischemic Heart Failure (STICH)
This study will compare medical therapy with coronary bypass surgery and/or surgical ventricular reconstruction for patients with congestive heart failure and coronary artery disease (CAD).

BACKGROUND:

Congestive heart failure afflicts approximately five million Americans and is the leading cause of hospitalization in Americans over the age of 65. Most cases of congestive heart failure are due to CAD. Surprisingly little is known about the relative benefits of medical versus surgical therapy for patients with obstructive coronary disease and congestive heart failure. Randomized studies of medical therapy versus bypass surgery for obstructive coronary disease were conducted in the 1970s and did not include the systematic use of aspirin, arterial conduits, or lipid-lowering medications. In addition, patients with ejection fractions below 35% were specifically excluded from the three large randomized studies of medical therapy versus bypass surgery. While observational data from the 1970s and early 1980s suggest a survival advantage associated with bypass surgery in patients with low ejection fraction and congestive heart failure, biases favoring the referral of the fittest of such patients for bypass surgery may have confounded these comparisons. In addition, medical therapy for congestive heart failure has improved dramatically over the past two decades. Thus, the choice of medical therapy versus bypass surgery for patients with congestive heart failure and obstructive coronary disease is usually decided by guesswork. This study is designed to provide a solid answer.

PURPOSE:

STICH is a multicenter, international, randomized trial that addresses two specific primary hypotheses in patients with clinical heart failure (HF) and left ventricular (LV) dysfunction who have coronary artery disease amenable to surgical revascularization.

The first hypothesis is that restoration of blood flow by means of coronary revascularization recovers chronic LV dysfunction and improves survival, as compared to intensive medical therapy alone. The second hypothesis is that surgical ventricular restoration (SVR) to a more normal LV size improves survival free of subsequent hospitalization for cardiac cause compared to CABG alone.

Patients eligible for either medical therapy or CABG, but not eligible for the SVR procedure (Stratum A), will be randomized in equal proportions to medical therapy alone versus CABG plus medical therapy. Patients eligible for all three therapies (Stratum B) will be randomized in equal proportions to medical therapy alone, CABG plus medical therapy, and CABG plus SVR plus medical therapy. Patients whose severity of angina or CAD makes them inappropriate for medical therapy alone (Stratum C) will be randomized in equal proportions to CABG plus medical therapy versus CABG plus SVR plus medical therapy.

The overall target was to recruit 1200 patients into Hypothesis One and 1,000 patients into Hypothesis Two. Secondary endpoints include the role of myocardial viability, morbidity, economics, and quality of life. Core laboratories for quality of life/economics, cardiac magnetic resonance (CMR), echocardiography (ECHO), neurohormonal/cytokine/genetic (NCG), and radionuclide (RN) studies ensure consistent testing practices and standardization of data necessary to identify eligible patients and to address specific questions related to the stated hypotheses.

IMPORTANCE OF RESEARCH:

The most common cause of HF is no longer hypertension or valvular heart disease as it was in previous decades, but rather CAD. HF is a common worldwide disease and CAD is a frequent cause of HF initiation and progression. HF is responsible for approximately 1 million hospitalizations and 300,000 fatalities annually. The prevalence of HF is increasing, largely due to enhanced survival following acute myocardial infarction and other manifestations of CAD. No randomized trial has ever compared directly the long-term benefits of surgical, medical, or combined surgical and medical treatment of patients with ischemic HF. The STICH trial is the first trial to compare the long term benefits of surgical and medical treatment in patients with ischemic HF. Although modern medical therapy for HF modestly improves quality of life, a more aggressive approach with the surgical therapies being studied in the STICH trial may produce even greater improvements. The common clinical practice of not offering CABG to patients with LV dysfunction in regions found to be nonviable on noninvasive studies is not evidence-based. Since only those patients for whom intensive medical therapy is the only reasonable therapeutic alternative are excluded from this study, the results of the STICH trial should be applicable to most patients with CAD, HF, and systolic LV dysfunction. The results of the STICH trial will also establish whether measurements of neurohormonal and cytokine levels and genetic profiling are useful for directing patient management decisions, for monitoring the effectiveness of therapy, and for refining the optimal approach for selecting the treatment strategy most likely to be effective for the many of these patients.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Cardiovascular Diseases
  • Coronary Disease
  • Heart Failure, Congestive
  • Heart Diseases
  • Procedure: CABG surgery plus MED
    CABG plus standard medication management for Coronary Artery Disease
  • Drug: Active Medication Alone
    Standard medication for coronary artery disease and heart failure management.
    Other Name: Standard medications for management of CAD and heart failure
  • Procedure: CABG plus MED and SVR
    H02: the experimental arm receives active medical therapy and CABG and surgical ventricular restoration whereas the control group receives active medical therapy and CABG; for H01: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone
  • Active Comparator: H01: Medication
    Medical therapy alone to treat Coronary Artery Disease
    Intervention: Drug: Active Medication Alone
  • Active Comparator: H01: Medication + CABG
    Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease
    Intervention: Procedure: CABG surgery plus MED
  • Active Comparator: H02: Medication+CABG
    Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease
    Intervention: Procedure: CABG surgery plus MED
  • Active Comparator: H02: Medication+CABG+SVR
    CABG plus Medication and Surgical ventricular reconstruction (SVR)
    Intervention: Procedure: CABG plus MED and SVR

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2136
November 2015
November 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • LV less than 35%, as defined by echocardiogram, left ventriculogram, CMR, or gated single photon emission computed tomography (SPECT) studies
  • Coronary anatomy suitable for revascularization

Exclusion Criteria:

  • Failure to provide informed consent.
  • Aortic valvular heart disease clearly indicating the need for aortic valve repair or replacement.
  • Cardiogenic shock (within 72 hours of randomization), as defined by the need for intraaortic balloon support or the requirement for intravenous inotropic support.
  • Plan for percutaneous intervention of CAD.
  • Recent acute MI judged to be an important cause of left ventricular dysfunction.
  • History of more than 1 prior coronary bypass operation.
  • Noncardiac illness with a life expectancy of less than 3 years.
  • Noncardiac illness imposing substantial operative mortality.
  • Conditions/circumstances likely to lead to poor treatment adherence (eg, history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode).
  • Previous heart, kidney, liver, or lung transplantation.
  • Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device.

MED Therapy Eligibility Criteria

  • Absence of left main CAD as defined by an intraluminal stenosis of 50% or greater.
  • Absence of CCS III angina or greater (angina markedly limiting ordinary activity).

SVR Eligibility Criterion

• Dominant akinesia or dyskinesia of the anterior left ventricular wall amenable to SVR.

Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00023595
Pro00018940
U01HL069009 ( U.S. NIH Grant/Contract )
U01HL069010 ( U.S. NIH Grant/Contract )
U01HL069011 ( U.S. NIH Grant/Contract )
U01HL069012 ( U.S. NIH Grant/Contract )
U01HL069013 ( U.S. NIH Grant/Contract )
U01HL069015 ( U.S. NIH Grant/Contract )
U01HL072683 ( U.S. NIH Grant/Contract )
R01HL105853 ( U.S. NIH Grant/Contract )
Pro00010463 ( Other Identifier: Duke IRB )
Yes
Not Provided
Not Provided
Duke University
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Robert Bonow Radionuclide Core Lab, Northwestern University
Principal Investigator: Arthur Feldman Neurohormonal Core Lab, Jefferson University
Principal Investigator: Eric Velazquez, MD Clinical Coordinating Center, Duke University
Principal Investigator: Kerry Lee Data Coordinating Center, Duke University
Principal Investigator: Daniel Mark Economics and Quality of Life Core Lab, Duke University
Principal Investigator: Jae Oh Echocardiographic Core Lab, Mayo Clinic
Principal Investigator: Gerald Pohost Magnetic Resonance Imaging Core Lab, University of Southern California
Study Chair: Jean Rouleau Université de Montréal
Principal Investigator: Julio A Panza, MD Washington Hospital Center
Duke University
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP