PROMISE Trial

PROMISE is a multicenter, randomized pragmatic trial comparing two state-of-the-art diagnostic strategies in approximately 10,000 symptomatic, low to intermediate risk subjects with suspected CAD who require non-urgent testing.

The investigational arm will use an “anatomic” testing strategy with coronary CTA (>64 slice) as the initial test. The usual care or “functional” testing strategy will use either stress imaging (echocardiography or nuclear) or exercise ECG as the initial test. All subsequent diagnostic and therapeutic management will be at the discretion of the treating care team.

The trial will encourage adherence to evidence based practice and document actual therapies used, but will not mandate specific care plans which will be left to the discretion of the clinical care team. Subjects will be randomized over approximately 24 months and followed for 24-48 months at 200-250 North American primary care, cardiology and acute care practice sites, reflecting the physician specialties and community settings where the vast majority of chest pain patients receive care.

• New or worsening chest pain syndrome or equivalent symptoms suspicious for clinically significant CAD with no prior evaluation for this episode of symptoms, and planned non-invasive testing for diagnosis
• Men over age 55 and women age 65 or older
• If age in men 45 - 54 or women 50 - 64 years, then must have increased probability of CAD due to either:
  
  • Diabetes Mellitus (DM) requiring medical treatment OR
    Peripheral Arterial Disease (PAD) OR cerebrovascular disease (stroke, documented > 50% carotid stenosis treated medically or invasively)
  • At least one of the following cardiovascular risk factors:
    
    • Ongoing tobacco use
    • Hypertension
    • Abnormal ABI defined as less than 0.9
    • Dyslipidemia
• Negative urine/serum pregnancy test for female subjects of child-bearing potential

Note: Certain exclusion criteria apply