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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01174550
First received: August 2, 2010
Last updated: October 15, 2013
Last verified: October 2013
  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
New Chest Pain Presentation
Procedure: Coronary CTA
Procedure: Functional stress test

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:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Time to first event - composite of major CV events [ Time Frame: 1 year minimum ] [ Designated as safety issue: No ]
    Time to first event, using a composite of major CV events: death, MI, major complications from CV procedures or testing, unstable angina hospitalization


Secondary Outcome Measures:
  • Death [ Time Frame: 1 year minimum ] [ Designated as safety issue: No ]
    Death

  • myocardial infarction [ Time Frame: 1 year minimum ] [ Designated as safety issue: No ]
    myocardial infarction

  • unstable angina hospitalization [ Time Frame: 1 year minimum ] [ Designated as safety issue: No ]
    unstable angina hospitalization

  • major complications from CV procedures [ Time Frame: 1 year minimum ] [ Designated as safety issue: No ]
    Major complications from cardiovascular procedures and testing (stroke, bleeding, anaphylaxis, renal failure)

  • cumulative radiation exposure [ Time Frame: 1 year minimum ] [ Designated as safety issue: Yes ]
    cumulative radiation exposure

  • Medical costs [ Time Frame: 1 year minimum ] [ Designated as safety issue: No ]
    Medical costs, resource use, and incremental cost effectiveness

  • quality of life [ Time Frame: 1 year minimum ] [ Designated as safety issue: No ]
    health related quality of life


Estimated Enrollment: 10000
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Functional stress tests
stress echo, stress nuclear, exercise ECG
Procedure: Functional stress test
functional stress tests: either stress echo, stress nuclear, or exercise ECG
Experimental: Coronary CT angiography (CTA)
Non-invasive anatomic imaging strategy: coronary CT angiography (CTA)
Procedure: Coronary CTA
anatomical imaging test via coronary CTA

Detailed Description:

Pragmatic randomized trial of clinical effectiveness of diagnostic testing strategies for 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 ECG, stress nuclear, or stress 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • new or worsening chest pain suspicious for clinically significant 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 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 ABI defined as less than <0.9, 4-Dyslipidemia
  • women age ≥65 years
  • women age ≥50 years with increased probability of 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 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 ACS requiring hospitalization or urgent or emergent testing; Elevated troponin or CK-MB
  • Hemodynamically or clinically unstable condition (systolic BP < 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy)
  • Known CAD with prior MI, PCI, CABG or any angiographic evidence of CAD ≥50% lesion in a major epicardial vessel
  • Any invasive coronary angiography or non-invasive anatomic or functional CV test for detection of CAD, including CTA and exercise 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 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
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
Investigators
Principal Investigator: Pamela S Douglas, MD Duke Clinical Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01174550     History of Changes
Other Study ID Numbers: Pro00019865 (702), R01HL098237-01
Study First Received: August 2, 2010
Last Updated: October 15, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Duke University:
chest pain
coronary artery disease
CAD

Additional relevant MeSH terms:
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014