Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date March 18, 2011
First Posted Date March 21, 2011
Last Update Posted Date March 21, 2011
Study Start Date April 2010
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: March 18, 2011)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Subclinical Atherosclerosis Using Dual-source CT Coronary Angiography in Chinese Adults With Different Glycaemic Status
Official Title Assessment of Subclinical Atherosclerosis Using Dual-source Computed Tomography Coronary Angiography in Chinese Adults With Different Glycaemic Status
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

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood and urine samples were collected and retained for biomarker analysis
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
Condition Thromboembolism
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: March 18, 2011)
600
Original Actual Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01319201
Other Study ID Numbers CCEMD009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Guang Ning/Professor, Shanghai Jiao-Tong University School of Medicine
Study Sponsor Shanghai Jiao Tong University School of Medicine
Collaborators Not Provided
Investigators
Principal Investigator: Guang Ning, M.D.; PH.D. Shanghai Jiao Tong University School of Medicine
PRS Account Shanghai Jiao Tong University School of Medicine
Verification Date March 2011