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

February 2, 2016 updated by: Duke University

PROspective Multicenter Imaging Study for Evaluation of Chest Pain - The PROMISE Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10003

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
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.
90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
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.
90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
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.
90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
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
Up to 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.
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).
Baseline, 6 months, 12 months 24 months
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.
Baseline, 6 month, 12 month, 24 month
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.
Baseline, 6 months, 12 months, 24 months
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
6 month, 12 month 24 month
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 2, 2010

First Submitted That Met QC Criteria

August 2, 2010

First Posted (Estimate)

August 3, 2010

Study Record Updates

Last Update Posted (Estimate)

February 29, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00019865
  • R01HL098237-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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."

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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