Subclinical Atherosclerosis Using Dual-source CT Coronary Angiography in Chinese Adults With Different Glycaemic Status

• Conditions: Thromboembolism

• Registration Number: NCT01319201
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

Part I: Survey of Coronary Artery Calcification and Stenosis in Participants with Different Glycaemic Status

Aims:

To evaluate coronary artery calcification and stenosis in community-dwelling adults with different glycaemic status, using dual-source CT angiography (CTA)

Study Subjects and Methods:

200 adults with normal glucose regulation (NGR), 200 with impaired glucose regulation (IGR) and 200 with type 2 diabetes were recruited from an urban community of Shanghai, who then underwent a comprehensive examination including questionnaire, anthropometric measurements, biochemical analysis and CTA.

Part II: Follow-up of Cardiovascular Events and Re-evaluation of Coronary Artery Calcification and Stenosis

Aims and Methods:

To investigate the development of cardiovascular diseases in subjects recruited in part I and re-evaluate coronary artery calcification and stenosis using CTA after 3-year follow-up

To identify the predictive value of coronary artery calcification and stenosis with future risks of cardiovascular diseases and the possible development of coronary artery disorders among participants with different glycaemic status

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Status Verified: 2011-03
• Study First Submitted: 2011-03-18
• Study First Submitted QC: 2011-03-18
• Last Update Submitted: 2011-03-18
• Study First Posted: 2011-03-21
• Last Update Posted: 2011-03-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Age between 40 and 70 years old
2. Gender: males and females
3. Provide written informed consent
4. Satisfactory compliance

Exclusion Criteria

1. History of cardiovascular diseases
2. Allergy to iodine
3. Exposure to radiation within last 3 months
4. ALT more than 100IU/L, or serum creatine more than 133μmol/l [1.5mg/dl] or GFR less than 60ml/min
5. Heart rate more than 100 bpm or severe arrhythmia
6. Malignancy, myocardial infection, acute hepatitis or other major diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants who will develop cardiovascular events during follow-up	3 years	Cardiovascular events include non-fatal myocardial infarction, non-fatal stroke and cardiovascular death. The progression of coronary artery calcium and stenosis is also evaluated at the final visit.

Trial Locations

Locations (1)

Shanghai Jiao-Tong University School of Medicine; 🇨🇳 Shanghai, China