At a glance
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Screening For Asymptomatic Obstructive Coronary Artery Disease Among High-Risk Diabetic Patients Using CT Angiography, Following Core 64: A Randomized Control Study (The faCTor-64 Study)
In Brief
A clinical study evaluating CT Angiography for Coronary Artery Disease. Completed, enrolled 900 participants across 1 site.
Detailed Summary
Patients with a known history of diabetes mellitus and no prior documented evidence of cardiovascular disease will be evaluated for inclusion in the study. Once qualified, patients will be enrolled and be randomized to either the Control Arm or to the Asymptomatic Screening Arm. Patients in the Control Arm will be followed by their primary care physicians with the recommendation that they follow standard guidelines for management of diabetic patients. Patients in the Asymptomatic Screening Arm will undergo CT screening for either coronary calcium scoring or multi-slice CT angiography as well as be placed on one of two medical regimens. Patients will be followed by telephone at six-month intervals for a minimum of one year for both primary and secondary outcomes.
Study Details
Timeline
Interventions
If results indicate blockage, patients will receive interventional assessment (i.e., angiography) and treatment if indicated. All patients will receive aggressive treatment for type II diabetes (hemoglobin A1C) and lipids.