Screening For Asymptomatic Obstructive Coronary Artery Disease Among High-Risk Diabetic Patients Using CT Angiography, Following Core 64

Completed · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00488033

Run by

Intermountain Health Care, Inc.

People needed

900

Starts

2007-06-01

Expected to finish

2014-08-01

Last updated by the study team

2017-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: Males ≥ 50 years; Females ≥55 years with: History of diabetes mellitus (prior documentation of fasting glucose ≥ 126 mg/dl or hemoglobin A1C > 6.5%), either type 1 or type 2, documented for at least 3 years and on medication for at least one year.
• Age: Males ≥ 40 years; Females ≥45 years with: History of diabetes mellitus (prior documentation of fasting glucose ≥ 126 mg/dl or hemoglobin A1C > 6.5%), either type 1 or type 2, documented for at least 5 years and on medication for at least one year.
• The patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local Institutional Review Board.

You may not qualify if…

• Known coronary artery disease (stenosis >70%, history of myocardial infarction, or angina)
• Symptomatic cerebral vascular disease (history of TIA, CVA, or cerebrovascular [carotid or cerebral arteries] revascularization)
• Symptomatic peripheral vascular disease (history of claudication, amputation, or peripheral [including renal arteries] arterial revascularization)
• Treatment with any other investigational drug within the previous 30 days
• Any therapy or condition that would pose a risk to the patient or make it difficult to comply with study requirements.
• Pregnant and/or lactating women, and women of child bearing potential not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
• Any life threatening condition/significant co-morbidity such that primary screening is inappropriate.

Where it is running

• Intermountain Healthcare — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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