Overview

This trial is active, not recruiting.

Condition thromboembolism
Sponsor Shanghai Jiao Tong University School of Medicine
Start date April 2010
Trial size 600 participants
Trial identifier NCT01319201, CCEMD009

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
This group of subjects was diagnosed as impaired glucose regulation using oral glucose tolerance test.
This group of subjects was diagnosed as type 2 diabetes using oral glucose tolerance test.
This group of subjects was considered normal regarding glucose metabolism using oral glucose tolerance test.

Primary Outcomes

Measure
Number of participants who will develop cardiovascular events during follow-up
time frame: 3 years

Eligibility Criteria

Male or female participants from 40 years up to 70 years old.

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

Additional Information

Official title Assessment of Subclinical Atherosclerosis Using Dual-source Computed Tomography Coronary Angiography in Chinese Adults With Different Glycaemic Status
Principal investigator Guang Ning, M.D.; PH.D.
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by Shanghai Jiao Tong University School of Medicine.