Screening For Asymptomatic Obstructive Coronary Artery Disease Among High-Risk Diabetic Patients Using CT Angiography, Following Core 64 (faCTor-64)
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 two years for both primary and secondary outcomes.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||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)|
- The combination of all cause death, non-fatal MI, and hospitalization for unstable angina. [ Time Frame: 2-years ] [ Designated as safety issue: No ]
- 1. CV death 2. Hospitalization for heart failure 3. Worsening renal failure (progression of serum creatinine by ≥0.5 mg/dL 4. Stroke or carotid revascularization procedure 5. Limb amputation or peripheral vascular disease [ Time Frame: 2-years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
No Intervention: 1
Standard of Care
Procedure: CT Angiography
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00488033
|United States, Utah|
|Salt Lake City, Utah, United States, 84143|
|Principal Investigator:||Joseph B Muhlestein, MD||Intermountain Health Care, Inc.|