PROspective Multicenter Imaging Study for Evaluation of Chest Pain - Full Text View

Purpose

A prospective multicenter imaging study for evaluation of chest pain. Objective is to determine whether an initial non-invasive anatomic imaging strategy with coronary CT angiography (CTA) will improve clinical outcomes in subjects with symptoms concerning for coronary artery disease relative to an initial functional testing strategy (usual care). Study hypothesis: initial anatomic testing strategy will provide information that will result in superior long-term health outcomes as compared to an initial functional testing strategy.

Condition	Intervention
Chest Pain	Procedure: Coronary Angiography Procedure: Stress Echocardiogram Procedure: Nuclear Stress Test Procedure: Exercise Electrocardiogram


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	PROspective Multicenter Imaging Study for Evaluation of Chest Pain - The PROMISE Trial

Resource links provided by NLM:

MedlinePlus related topics: Chest Pain

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

Time to Primary Endpoint [ Time Frame: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months ]
Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.

Secondary Outcome Measures:

Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization [ Time Frame: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months ]
Time to this secondary endpoint as defined as a composite of death, myocardial infarction (MI), and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Time to Death or Myocardial Infarction (MI) [ Time Frame: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months ]
Time to this secondary endpoint as defined as a composite of death and myocardial infarction (MI). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Time to Major Complications From Cardiovascular (CV) Procedures [ Time Frame: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months ]
Time to this secondary endpoint as defined as a composite of major complications from cardiovascular procedures and testing (stroke, bleeding, anaphylaxis, renal failure). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) [ Time Frame: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months ]
Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, unstable angina hospitalization, and no coronary artery disease (CAD). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization [ Time Frame: Up to 90 days following participant randomization ]
Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease (CAD)Within 90 Days Following Participant Randomization
Medical Cost [ Time Frame: 90 days and 3 years cumulative ]
Assess and compare total medical cost for the two diagnostic testing arms by intention to treat at both 90 days and 3 years cumulative.
Quality of Life (QOL) as Measured by Duke Activity Status Index [ Time Frame: Baseline, 6 months, 12 months 24 months ]
Participant score in Quality of Life as measured by Duke Activity Status Index (DASI). DASI measures a person's functional capacity based on a 12-item questionnaire that correlates with peak O2 uptake during exercise testing. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).
Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale [ Time Frame: Baseline, 6 month, 12 month, 24 month ]
Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning & summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable & less frequent, condition has less impact on activities, increased satisfaction with treatment, & perception of disease has less impact on interpersonal relationships.
Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale [ Time Frame: Baseline, 6 months, 12 months, 24 months ]
Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning & summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable & less frequent, condition has less impact on activities, increased satisfaction with treatment, & perception of disease has less impact on interpersonal relationships.
Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing [ Time Frame: 6 month, 12 month 24 month ]
Percentage of participants with improvement in Quality of Life as measured by complete resolution of the symptoms that led to initial testing
Cumulative Radiation Exposure Within 90 Days [ Time Frame: 90 days ]
Cumulative radiation exposure from all cardiovascular diagnostic tests and procedures performed within 90 days after randomization.


Enrollment:	10003
Study Start Date:	July 2010
Study Completion Date:	October 2014
Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Functional diagnostic tests Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram	Procedure: Stress Echocardiogram Use of standard equipment for usual-care testing Procedure: Nuclear Stress Test Use of standard equipment for usual-care testing Procedure: Exercise Electrocardiogram Use of standard equipment for usual-care testing
Active Comparator: Anatomic diagnostic test Coronary Angiography	Procedure: Coronary Angiography Use of standard equipment for usual-care testing

Detailed Description:

Pragmatic randomized trial of clinical effectiveness of diagnostic testing strategies for coronary artery disease (CAD), to be performed in outpatient settings including acute and primary care and cardiology offices. Qualifying patients presenting with new or worsening symptoms suspicious for clinically significant CAD who require diagnostic testing and have not been previously evaluated will be randomized to an initial strategy of either anatomic or functional testing. All subsequent decisions regarding additional testing, medications and/or procedures will be at the discretion of the responsible clinical care team Within the functional testing arm, the subject's care team will select the specific test to be performed (exercise electrocardiogram (ECG), stress nuclear, or stress echocardiogram (echo)) consistent with 'usual care' in that practice setting. The subject's care team will be provided with 'Information sheets' summarizing current standards for test interpretation and preventive care, but specific medical treatment will not be mandated by the trial.

Eligibility


Ages Eligible for Study:	45 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

new or worsening chest pain suspicious for clinically significant coronary artery disease (CAD)
no prior evaluation for this episode of symptoms
planned non-invasive testing for diagnosis
men age ≥55 years
men age ≥45 years with increased probability of coronary artery disease (CAD) due to either (A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented >50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented > 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than <0.9, 4-Dyslipidemia
women age ≥65 years
women age ≥50 years with increased probability of coronary artery disease (CAD) due to either (A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented >50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented > 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than <0.9, 4-Dyslipidemia
Serum creatinine ≤ 1.5 mg/dL within the past 90 days
Negative urine/serum pregnancy test for female subjects of child-bearing potential

Exclusion Criteria:

Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing; Elevated troponin or creatine kinase-myocardial band (CK-MB)
Hemodynamically or clinically unstable condition systolic blood pressure (BP) < 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy)
Known coronary artery disease (CAD) with prior Myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or any angiographic evidence of coronary artery disease (CAD) ≥50% lesion in a major epicardial vessel
Any invasive coronary angiography or non-invasive anatomic or functional cardiovascular (CV) test for detection of coronary artery disease (CAD), including coronary tomographic angiography (CTA) and exercise electrocardiogram (ECG), within the previous twelve (12) months
Known significant congenital, valvular (> moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (LVEF) ≤ 40%)) which could explain cardiac symptoms
Contraindication to undergoing a coronary tomographic angiography (CTA), including but not limited to: a. Allergy to iodinated contrast agent, b. Unable to receive beta blockers unless heart rate < 65 beats per minute, c. Pregnancy
Life expectancy < 2 years
Unable to provide written informed consent or participate in long-term follow-up

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: NCT01174550

Locations


United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27701

Sponsors and Collaborators

Duke University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators


Principal Investigator:	Pamela S Douglas, MD	Duke Clinical Research Institute

More Information

Additional Information:

PROMISE trial web site This link exits the ClinicalTrials.gov site

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

Mark DB, Federspiel JJ, Cowper PA, Anstrom KJ, Hoffmann U, Patel MR, Davidson-Ray L, Daniels MR, Cooper LS, Knight JD, Lee KL, Douglas PS; PROMISE Investigators. Economic Outcomes With Anatomical Versus Functional Diagnostic Testing for Coronary Artery Disease. Ann Intern Med. 2016 Jul 19;165(2):94-102. doi: 10.7326/M15-2639. Epub 2016 May 24.

Mark DB, Anstrom KJ, Sheng S, Baloch KN, Daniels MR, Hoffmann U, Patel MR, Cooper LS, Lee KL, Douglas PS; PROMISE Investigators. Quality-of-Life Outcomes With Anatomic Versus Functional Diagnostic Testing Strategies in Symptomatic Patients With Suspected Coronary Artery Disease: Results From the PROMISE Randomized Trial. Circulation. 2016 May 24;133(21):1995-2007. doi: 10.1161/CIRCULATIONAHA.115.020259. Epub 2016 Apr 27.

Douglas PS, Hoffmann U, Patel MR, Mark DB, Al-Khalidi HR, Cavanaugh B, Cole J, Dolor RJ, Fordyce CB, Huang M, Khan MA, Kosinski AS, Krucoff MW, Malhotra V, Picard MH, Udelson JE, Velazquez EJ, Yow E, Cooper LS, Lee KL; PROMISE Investigators. Outcomes of anatomical versus functional testing for coronary artery disease. N Engl J Med. 2015 Apr 2;372(14):1291-300. doi: 10.1056/NEJMoa1415516. Epub 2015 Mar 14.

Douglas PS, Hoffmann U, Lee KL, Mark DB, Al-Khalidi HR, Anstrom K, Dolor RJ, Kosinski A, Krucoff MW, Mudrick DW, Patel MR, Picard MH, Udelson JE, Velazquez EJ, Cooper L; PROMISE investigators. PROspective Multicenter Imaging Study for Evaluation of chest pain: rationale and design of the PROMISE trial. Am Heart J. 2014 Jun;167(6):796-803.e1. doi: 10.1016/j.ahj.2014.03.003. Epub 2014 Mar 18.


Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT01174550 History of Changes
Other Study ID Numbers:	Pro00019865 R01HL098237-01 ( U.S. NIH Grant/Contract )
Study First Received:	August 2, 2010
Results First Received:	October 19, 2015
Last Updated:	February 2, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Data will be submitted to the NHLBI according to their guidelines which state"The data sets must be submitted to the study NHLBI study Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center and sent to the PO for review prior to release."

Keywords provided by Duke University:


chest pain coronary artery disease CAD

Additional relevant MeSH terms:


Chest Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms

ClinicalTrials.gov processed this record on July 17, 2017

PROspective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE)