Validation Study of Coronary CT Angiography as a Screening Tool in Asymptomatic Diabetes

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT00431977
First received: February 5, 2007
Last updated: June 20, 2011
Last verified: October 2006
  Purpose

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.


Condition Intervention
Coronary Atherosclerosis
Diabetes Mellitus
Procedure: coronary computed tomography angiography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: DEtection of Subclinical Coronary AtheRosclerosis in diabeTES Using Coronary CT Angiography (DESCARTES Trial)

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Myocardial infarction
  • Late revascularization therapy
  • Cardiac death

Secondary Outcome Measures:
  • Early revascularization therapy
  • Other procedure (i.e. peripheral vascular procedure)
  • All-caused death

Estimated Enrollment: 1000
Study Start Date: November 2006
Estimated Study Completion Date: December 2012
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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Age 50 ~ 75 years

Exclusion Criteria:

  • angina pectoris or anginal equivalent symptoms
  • insulin pump user or history of ketoacidosis
  • history of myocardial infarction, heart failure, or coronary revascularization
  • electrocardiographic evidence of Q-wave myocardial infarction, ischemic ST- segment or T-wave changes, or complete left bundle branch block
  • uncontrolled arrythmia
  • hypersensitivity to contrast dye
  • renal failure
  • uncontrolled arrythmia
  • hypersensitivity to contrast dye
  • renal failure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431977

Locations
Korea, Republic of
Seoul National University Bundang hospital
Sungnam-si, Kyungki-do, Korea, Republic of
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Study Director: Huk-Jae Chang, MD, PhD Seoul National University Bundang Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00431977     History of Changes
Other Study ID Numbers: B-0610/038-002
Study First Received: February 5, 2007
Last Updated: June 20, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:
Coronary Atherosclerosis
Diabetes Mellitus

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Diabetes Mellitus
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014