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

Thromboembolism Clinical Trial

Official title:

Assessment of Subclinical Atherosclerosis Using Dual-source Computed Tomography Coronary Angiography in Chinese Adults With Different Glycaemic Status

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01319201
• Other study ID #: CCEMD009
• Status: Active, not recruiting
• Phase: N/A
• First received: March 18, 2011
• Last updated: March 18, 2011
• Start date: April 2010

Study information

• Verified date: March 2011
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Thromboembolism

Locations

Country	Name	City	State
China	Shanghai Jiao-Tong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who will develop cardiovascular events during follow-up	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.	3 years	No