Diabetes Mellitus Clinical Trial
Official title:
DEtection of Subclinical Coronary AtheRosclerosis in diabeTES Using Coronary CT Angiography (DESCARTES Trial)
The purpose of this study is to evaluate the prevalence and clinical predictors of subclinical coronary atherosclerosis and to validate the usefulness of coronary CT angiography as a screening tool in asymptomatic patients with type 2 diabetes mellitus.
Coronary artery disease (CAD) is the leading cause of death in patients with diabetes.
Patients with diabetes are known to have silent myocardial ischemia more frequently than
those without diabetes. Furthermore, CAD in patients with diabetes frequently manifested in
advance stage, and morbidity and mortality are higher than those without diabetes. Early
screening and treatment of CAD in asymptomatic patients with diabetes might reduce high
morbidity and mortality.
In recent advance in technology, coronary CT angiography makes it more accurately and easier
in detecting CAD not only in symptomatic patients but also in asymptomatic population. In
asymptomatic population, coronary CT angiography could detect subclinical coronary
atherosclerosis with high sensitivity and specificity. However, there is a paucity of
information on the role of coronary CT angiography as a screening method in high risk
asymptomatic population, i.e. asymptomatic patients with diabetes.
Therefore in our study, we will evaluate the prevalence and clinical predictors of
subclinical coronary atherosclerosis and to validate the usefulness of coronary CT
angiography as a screening tool in asymptomatic patients with type 2 diabetes mellitus.
In this study, we will recruit asymptomatic patients with diabetes. At the time of
enrollment, patients will be randomly assigned to coronary CT angiography group or control
group using web-based randomization table. One-half of patients will be assigned to coronary
CT angiography imaging and follow-up, whereas the other half will be randomized to medical
treatment and follow-up only.
When the patients are eligible for study, investigators will give information about the
study and obtain written consent. The presence of chest pain symptom will be screened with
Rose questionnaire. Medical history and physical examination will be performed, and baseline
laboratory work-up will be performed. Investigators will evaluate the status of diabetic
complication (retinopathy/nephropathy/cardiac autonomic neuropathy).
After initial clinical and laboratory evaluation, all patients will be followed for adverse
cardiac events for 5 years.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
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