PROspective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE)
This study is currently recruiting participants.
Verified February 2013 by Duke University
Sponsor:
Duke University
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01174550
First received: August 2, 2010
Last updated: February 21, 2013
Last verified: February 2013
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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: | August 2014 |
| Estimated Primary Completion Date: | August 2013 (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
Contacts
| Contact: Pamela S Douglas, MD | 919-681-2690 | pamela.douglas@duke.edu |
| Contact: Manesh R Patel, MD | 919-668-7807 | patel017@mc.duke.edu |
Locations
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27701 | |
| Contact: David F Kong, MD 919-668-8946 david.f.kong@duke.edu | |
| Contact: Rowena J Dolor, MD 919-668-8596 rowena.dolor@duke.edu | |
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: | February 21, 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 May 16, 2013