Randomized Evaluation of Patients With Stable Angina Comparing Diagnostic Examinations

Stopped early · Not applicable

Conditions studied: Chest Pain, Stable Angina Pectoris, CCS Class I to III, Angina Equivalent, Coronary Artery Disease

In brief

This randomized, controlled, diagnostic, multicenter trial will compare two diagnostic imaging pathways--coronary computed tomography angiography (CCTA) and single photon emission tomography (SPECT) myocardial perfusion imaging (MPI)--to determine the incidence of major adverse coronary events (MACE), defined as myocardial infarction (MI) or cardiac-related death, and cross-over to revascularization. CCTA may be used to direct patients with symptoms of stable angina or angina equivalent to optimal medical therapy (OMT). The use of CCTA as a diagnostic tool for angina symptoms will be associated with no increase in MACE or revascularization, decreased cost, reduced risks (e.g., less radiation exposure), additional insights into alternate explanations of chest pain, and increased cost-effectiveness in comparison with use of SPECT MPI/invasive coronary angiography (ICA).

Key facts

Study ID

NCT01262625

Run by

American College of Radiology

People needed

1050

Starts

2011-05-20

Expected to finish

2015-02-01

Last updated by the study team

2023-12-26

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to provide a written informed consent;
• 40 years or older;
• Presentation with symptoms of stable angina (CCS Class I to III) or angina equivalent with or without known CAD;
• Planned non-invasive imaging for CAD diagnosis;
• 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.

You may not qualify if…

• Prior revascularization;
• Not suitable to undergo CT with an iodinated contrast agent:
• Known allergy-like reaction to contrast media as defined by the American College of Radiology (ACR) (see www.acr.org/SecondaryMainMenuCategories/quality_safety/contrast_manual.aspx for reaction definition) or moderate to severe allergic reactions to more than one allergen;
• Renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 based on a serum creatinine level obtained within 28 days prior to registration;
• Renal insufficiency at the time of enrollment, as determined by GFR 30 to 60 mL/min/1.73 m2 based on a serum creatinine level obtained within 28 days prior to registration, unless permitted by the institution's policy and/or ACR guidance for risk reduction strategies (see www.acr.org/SecondaryMainMenuCategories/quality_safety/contrast_manual.aspx for guidance on contrast selection and pre-treatment strategies);
• Atrial fibrillation or significant arrhythmia judged to potentially limit quality of CCTA;
• Acute ischemia;
• Acute myocardial infarction;
• Severe myocardial ischemia: known markedly positive exercise treadmill stress test (ST) [significant ST segment depressions or hypotensive response during stage I of the Bruce protocol];
• Unable to suspend respiration for 15 seconds or to follow instructions to do so;
• Unstable angina and symptoms refractory to maximal oral and intravenous medical therapy (persistent CCS Class IV);
• History of known left ventricular ejection fraction < 45%;
• Pulmonary edema or heart failure unresponsive to standard medical therapy;
• Pacemaker;
• Valvular heart disease likely to require surgery in the next 18 months;
• Congenital heart disease or cardiomyopathy likely to affect prognosis during follow up;
• Significant systemic hypertension (blood pressure > 200/100 mm Hg) unresponsive to medical therapy;
• 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);
• Prior imaging evaluation for this episode of symptoms (e.g., SPECT MPI or CCTA within the previous 72 hours);
• BMI > 40 kg/m2;
• 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).

Where it is running

• Atlantic VA Medical Center — Decatur, Georgia, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Salem VA Medical Center — Salem, Virginia, United States

Full record on ClinicalTrials.gov

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