Validation Study of Coronary CT Angiography as a Screening Tool in Asymptomatic Diabetes
Primary Purpose
Coronary Atherosclerosis, Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
coronary computed tomography angiography
Sponsored by
About this trial
This is an interventional screening trial for Coronary Atherosclerosis focused on measuring Coronary Atherosclerosis, Diabetes Mellitus
Eligibility 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
Sites / Locations
- Seoul National University Bundang hospital
Outcomes
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
Full Information
NCT ID
NCT00431977
First Posted
February 5, 2007
Last Updated
June 20, 2011
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00431977
Brief Title
Validation Study of Coronary CT Angiography as a Screening Tool in Asymptomatic Diabetes
Official Title
DEtection of Subclinical Coronary AtheRosclerosis in diabeTES Using Coronary CT Angiography (DESCARTES Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2012 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Atherosclerosis, Diabetes Mellitus
Keywords
Coronary Atherosclerosis, Diabetes Mellitus
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
coronary computed tomography angiography
Primary Outcome Measure Information:
Title
Myocardial infarction
Title
Late revascularization therapy
Title
Cardiac death
Secondary Outcome Measure Information:
Title
Early revascularization therapy
Title
Other procedure (i.e. peripheral vascular procedure)
Title
All-caused death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huk-Jae Chang, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Bundang hospital
City
Sungnam-si
State/Province
Kyungki-do
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Validation Study of Coronary CT Angiography as a Screening Tool in Asymptomatic Diabetes
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