PROspective Multicenter Imaging Study for Evaluation of Chest Pain
PROspective Multicenter Imaging Study for Evaluation of Chest Pain
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
 coronary artery disease (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 electrocardiogram (ECG), stress nuclear, or stress echocardiogram (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.
Inclusion Criteria:

 -  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 Criteria:

 -  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