Status:
COMPLETED
PROspective Multicenter Imaging Study for Evaluation of Chest Pain
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Chest Pain
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
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 improv...
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 car...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
10003 Patients enrolled
Trial Details
Trial ID
NCT01174550
Start Date
July 1 2010
End Date
October 1 2014
Last Update
February 29 2016
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27701