PROspective Multicenter Imaging Study for Evaluation of Chest Pain

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
  • Study Primary Completion Date: November 2014

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • Procedure: Coronary CTA
    • anatomical imaging test via coronary CTA
  • Procedure: Functional stress test
    • functional stress tests: either stress echo, stress nuclear, or exercise ECG

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Functional stress tests
    • stress echo, stress nuclear, exercise ECG
  • Experimental: Coronary CT angiography (CTA)
    • Non-invasive anatomic imaging strategy: coronary CT angiography (CTA)

Outcome Measures for this Clinical Trial

Primary Measures

  • Time to first event – composite of major CV events
    • Time Frame: 1 year minimum
      Safety Issue?: No

Secondary Measures

  • Death
    • Time Frame: 1 year minimum
      Safety Issue?: No
  • myocardial infarction
    • Time Frame: 1 year minimum
      Safety Issue?: No
  • unstable angina hospitalization
    • Time Frame: 1 year minimum
      Safety Issue?: No
  • major complications from CV procedures
    • Time Frame: 1 year minimum
      Safety Issue?: No
  • cumulative radiation exposure
    • Time Frame: 1 year minimum
      Safety Issue?: Yes
  • Medical costs
    • Time Frame: 1 year minimum
      Safety Issue?: No
  • quality of life
    • Time Frame: 1 year minimum
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Duke University
  • Collaborator
    • National Heart, Lung, and Blood Institute (NHLBI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pamela S Douglas, MD, Principal Investigator, Duke Clinical Research Institute

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01174550