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

NCT ID: NCT01319201

Last Updated: 2011-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Brief Summary

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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

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Conditions

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Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Impaired glucose regulation

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

No interventions assigned to this group

Type 2 diabetes

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

No interventions assigned to this group

Normal glucose regulation

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Shanghai Jiao-Tong University School of Medicine

Principal Investigators

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Guang Ning, M.D.; PH.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

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Shanghai Jiao-Tong University School of Medicine

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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CCEMD009

Identifier Type: -

Identifier Source: org_study_id

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