To determine the effectiveness, safety, and cost efficiency associated with a CCTA-guided selective catheterization strategy for stable patients but without known CAD and an American Heart Association/ American College of Cardiology Class II indication for non-emergent invasive coronary angiography.
A prospective, randomized controlled multicenter trial to determine the clinical and cost effectiveness of a "selective catheterization" strategy versus a "direct catheterization" strategy for stable patients with suspected but without known CAD and clinical indication for non-emergent invasive coronary angiography. Subjects in the "selective catheterization" arm will be followed for a primary endpoint of non-inferiority for rates of major adverse cardiac events (MACE) as compare to subjects in the "direct catheterization" strategy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
1,631
Perform a non-invasive Cardiac CT Angiogram
Patient undergoes Invasive Coronary Angiography
Walter Reed Medical Center
Bethesda, Maryland, United States
Quanta Diagnostico Nuclear, Curitiba-PR
Curitiba, Brazil
FACTS
Hyderabad, India
MACE Endpoints
* Death * Non-fatal myocardial infarction * Unstable angina (including new onset angina or those requiring hospitalization, revascularization or that are troponin-positive) * Stroke * Urgent or emergent coronary revascularization * Cardiovascular hospitalization (including for angina, heart failure or other)
Time frame: 1 year
Additional MACE Endpoints
* The primary composite MACE endpoint plus major bleeding. * The primary composite MACE endpoint plus major bleeding or need for urgent/ emergent surgery due to hemorrhage. * The primary composite MACE endpoint plus major bleeding plus need for urgent/ emergent surgery due to hemorrhage plus need for major transfusion.
Time frame: 1 year
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Centro Cardiologico Monzino
Monzino, Italy
Institute of Cardiology Warsaw
Warsaw, Poland
Kangwon National University Hospital
Seoul, South Korea, South Korea
Ajou University Hospital
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Gangneung Asan Hospital
Seoul, South Korea
Korea university, Guro hospital
Seoul, South Korea
...and 3 more locations