Validation Study of Coronary CT Angiography as a Screening Tool in Asymptomatic Diabetes
Condition: Coronary Atherosclerosis; Diabetes Mellitus
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): coronary computed tomography angiography
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Coronary Atherosclerosis; Diabetes Mellitus