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

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ClinicalTrials.gov Identifier: NCT01319201
Recruitment Status : Unknown
Verified March 2011 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Active, not recruiting
First Posted : March 21, 2011
Last Update Posted : March 21, 2011
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine

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


Condition or disease
Thromboembolism

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Subclinical Atherosclerosis Using Dual-source Computed Tomography Coronary Angiography in Chinese Adults With Different Glycaemic Status
Study Start Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

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.



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Blood and urine samples were collected and retained for biomarker analysis


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319201


Locations
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China
Shanghai Jiao-Tong University School of Medicine
Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Guang Ning, M.D.; PH.D. Shanghai Jiao Tong University School of Medicine
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Responsible Party: Guang Ning/Professor, Shanghai Jiao-Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01319201    
Other Study ID Numbers: CCEMD009
First Posted: March 21, 2011    Key Record Dates
Last Update Posted: March 21, 2011
Last Verified: March 2011
Additional relevant MeSH terms:
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Atherosclerosis
Thromboembolism
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Embolism and Thrombosis