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: July 14, 2014
Last verified: October 2013

August 2, 2010
July 14, 2014
July 2010
November 2014   (final data collection date for primary outcome measure)
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
Time to first event - composite of major CV events [ Time Frame: 2 years ] [ 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
Complete list of historical versions of study NCT01174550 on ClinicalTrials.gov Archive Site
  • 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
  • Death [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Death
  • myocardial infarction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    myocardial infarction
  • unstable angina hospitalization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    unstable angina hospitalization
  • major complications from CV procedures [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Major complications from cardiovascular procedures and testing (stroke, bleeding, anaphylaxis, renal failure)
  • cumulative radiation exposure [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    cumulative radiation exposure
  • Medical costs [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Medical costs, resource use, and incremental cost effectiveness
  • quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    health related quality of life
Not Provided
Not Provided
 
PROspective Multicenter Imaging Study for Evaluation of Chest Pain
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
New Chest Pain Presentation
  • Procedure: Coronary CTA
    anatomical imaging test via coronary CTA
  • Procedure: Functional stress test
    functional stress tests: either stress echo, stress nuclear, or exercise ECG
  • Active Comparator: Functional stress tests
    stress echo, stress nuclear, exercise ECG
    Intervention: Procedure: Functional stress test
  • Experimental: Coronary CT angiography (CTA)
    Non-invasive anatomic imaging strategy: coronary CT angiography (CTA)
    Intervention: Procedure: Coronary CTA
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10000
December 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01174550
Pro00019865, R01HL098237-01, 702
Yes
Duke University
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Pamela S Douglas, MD Duke Clinical Research Institute
Duke University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP