PROMISE Substudy to Assess For Effective Dose of Radiation (PROMISE-SAFER) Specific Aim 3b

Inclusion criteria

All patients who meet inclusion criteria and enroll in the parent PROMISE study will be eligible to participate in PROMISE-SAFER.

• New or worsening chest pain syndrome or equivalent symptoms suspicious for clinically significant coronary artery disease
• No prior evaluation for this episode of symptoms
• Planned non-invasive testing for evaluation of possible coronary artery disease
• Men age > 55 and women age ≥65 years
• If age in men 45 - 54 or women 50 - 64 years, then must have 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:

• Ongoing tobacco use
• Hypertension
• Abnormal ankle-brachial index defined as less than <0.9
• Dyslipidemia
• Serum creatinine < 1.5 mg/dL within the past 90 days
• Negative urine/serum pregnancy test for female subjects of child-bearing potential and not breast-feeding

Exclusion criteria

• Diagnosed or suspected acute coronary syndrome requiring hospitalization or urgent or emergent testing; Elevated troponin or creatinine kinase-MB
• Hemodynamically or clinically unstable condition (systolic blood pressure < 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy)
• Known coronary artery disease with prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting or any angiographic evidence of coronary artery disease ≥50% lesion in a major epicardial vessel.
• Any invasive coronary angiography or non-invasive anatomic or functional cardiovascular test for detection of coronary artery disease, including coronary computed tomographic angiography and exercise electrocardiogram, within the previous twelve (12) months.
• Known significant congenital, valvular (> moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (left ventricular ejection fraction ≤ 40%)) which could explain cardiac symptoms.
• Contraindication to undergoing a coronary computed tomographic angiography, including but not limited to:

a. Pregnancy or breastfeeding

• Life expectancy < 2 years
• Unable to provide written informed consent or participate in long-term follow-up