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

March 18, 2011 updated by: Shanghai Jiao Tong University School of Medicine

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

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200025
        • Shanghai Jiao-Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who will develop cardiovascular events during follow-up
Time Frame: 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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Guang Ning, M.D.; PH.D., Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Study Registration Dates

First Submitted

March 18, 2011

First Submitted That Met QC Criteria

March 18, 2011

First Posted (Estimate)

March 21, 2011

Study Record Updates

Last Update Posted (Estimate)

March 21, 2011

Last Update Submitted That Met QC Criteria

March 18, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCEMD009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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