Chest Pain Stable Angina Pectoris, CCS Class I to III Angina Equivalent Coronary Artery Disease
Conditions
Interventions
1. Device: CCTA
2. Device: SPECT MPI/ICA.
Sponsors
American College of Radiology Imaging Network
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide a written informed consent; 2. 40 years or older; 3. Presentation with symptoms of stable angina (CCS Class I to III) or angina equivalent with or without known CAD; 4. Planned non-invasive imaging for CAD diagnosis; 5. Able to tolerate CCTA or SPECT MPI per randomization as required by protocol, to be performed at an ACRIN-qualified facility with a RESCUE-qualified scanner.
Exclusion criteria
Exclusion criteria: 1. Prior revascularization; 2. Not suitable to undergo CT with an iodinated contrast agent; 3. Known allergy-like reaction to contrast media as defined by the American College of Radiology (ACR) (or moderate to severe allergic reactions to more than one allergen; 4. Renal failure, as determined by glomerular filtration rate (GFR) 200/100 mm Hg) unresponsive to medical therapy; 18. Severe noncardiovascular comorbidity limiting survival (e.g., cancer or other life threatening illness for which the patient is expected to live less than 12 months); 19. Prior imaging evaluation for this episode of symptoms (e.g., SPECT MPI or CCTA within the previous 72 hours); 20. BMI > 40 kg/m2; 21. Pregnancy or intent to become pregnant (if a female is of childbearing potential—defined as a premenopausal female capable of becoming pregnant—a pregnancy test should be done prior to enrollment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare outcomes of participants with symptoms of stable angina or angina equivalent evaluated with an anatomic imaging strategy using CCTA as initial method of CAD diagnosis (Group A) to a combined functional and anatomic imaging strategy of SPECT MPI/ICA (Group B) as a guide to OMT. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the ability of available prognostic indices to predict revascularization or MACE using CCTA information and to develop new indices using the RESCUE trial data; 2. To determine the cost, effectiveness, and incremental cost-effectiveness of CCTA versus SPECT MPI/ICA in the evaluation of participants with symptoms of stable angina; 3. To compare angina symptoms and self-reported health status of participants with symptoms of stable angina undergoing CCTA as initial method of CAD diagnosis to SPECT MPI/ICA as a guide to OMT. | — |
Contacts
Public ContactR. Vliegenthart
Center for Medical Imaging - North East Netherlands Dept of Radiology University of Groningen / University Medical Center Groningen
Outcome results
None listed