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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
  Purpose
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).

Condition Intervention Phase
Cardiovascular Diseases Coronary Disease Heart Failure, Congestive Heart Diseases Procedure: CABG surgery plus MED Drug: Active Medication Alone Procedure: CABG plus MED and SVR Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Treatment for Ischemic Heart Failure (STICH)

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 2136
Study Start Date: January 2002
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: H01: Medication
Medical therapy alone to treat 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
Active Comparator: H01: Medication + CABG
Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease
Procedure: CABG surgery plus MED
CABG plus standard medication management for Coronary Artery Disease
Active Comparator: H02: Medication+CABG
Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease
Procedure: CABG surgery plus MED
CABG plus standard medication management for Coronary Artery Disease
Active Comparator: H02: Medication+CABG+SVR
CABG plus Medication and Surgical ventricular reconstruction (SVR)
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

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  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023595

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27715
Sponsors and Collaborators
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00023595     History of Changes
Other Study ID Numbers: 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 )
Study First Received: September 11, 2001
Results First Received: December 23, 2016
Last Updated: July 20, 2017

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 22, 2017