Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431977
Status:
COMPLETED
Last Update Posted:
2011-06-21
First Post:
2007-02-05
Brief Title:
Validation Study of Coronary CT Angiography as a Screening Tool in Asymptomatic Diabetes
Sponsor:
Seoul National University Bundang Hospital
Organization:
Seoul National University Bundang Hospital
Study Overview
Official Title:
DEtection of Subclinical Coronary AtheRosclerosis in diabeTES Using Coronary CT Angiography DESCARTES Trial
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 retinopathynephropathycardiac autonomic neuropathy
After initial clinical and laboratory evaluation all patients will be followed for adverse cardiac events for 5 years
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 ie 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 retinopathynephropathycardiac autonomic neuropathy
After initial clinical and laboratory evaluation all patients will be followed for adverse cardiac events for 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None