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

NCT01319201 | Unknown DMC

• 1 other identifier: CCEMD009
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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

Conditions

Thromboembolism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Impaired glucose regulation

This group of subjects was diagnosed as impaired glucose regulation using oral glucose tolerance test.

Type 2 diabetes

This group of subjects was diagnosed as type 2 diabetes using oral glucose tolerance test.

Normal glucose regulation

This group of subjects was considered normal regarding glucose metabolism using oral glucose tolerance test.

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Age between 40 and 70 years old
• Gender: males and females
• Provide written informed consent
• Satisfactory compliance

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Jiao-Tong University School of Medicine

Shanghai, 200025, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples were collected and retained for biomarker analysis

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Guang Ning, M.D.; PH.D.

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: March 21, 2011
• Study Start: April 1, 2010
• Last Updated: March 21, 2011

Record last verified: 2011-03

Locations

CN (1)