- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00784264
A Study on Intima Media Thickness (IMT) in Middle-aged Subjects (IMT)
January 11, 2010 updated by: AstraZeneca
This is an observational study to measure the thickness of artery walls in the neck (intima media thickness IMT) by ultrasound examination in middle-aged subjects with central obesity.
The purpose of this study is to obtain local data how common asymptomatic atherosclerosis is, and to investigate the association between Cardiovascular Disease risk factors and intima media thickness (IMT) in the Hong Kong population.
Results from this study may enhance the public awareness of asymptomatic atherosclerosis and understand its role in the development of Cardiovascular Disease in Hong Kong.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
200
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
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Hong Kong, Hong Kong
- Research Site
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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
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
aged 55 or above with central obesity, male more than 90 cm; female more than 80 cm
Description
Inclusion Criteria:
- Male or female aged 55 years or above.
- Waist circumference: male more than 90 cm; female more than 80 cm.
Exclusion Criteria:
- Any known chronic diseases requiring long-term medication such as hypertension, diabetes and hyperlipidemia.
- Presence of known cardiovascular diseases including cerebro-vascular disease, coronary heart disease and peripheral artery disease.
- Presence of any active major diseases that may interfere the physical conditions and body weight of subjects during the study period, which include malignancy, infection, renal or liver function impairment, recent major surgery (within 3 months).
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To investigate the prevalence of asymptomatic atherosclerosis by measurement of intima media thickness (IMT) in middle-aged subjects with central obesity in Hong Kong,
Time Frame: during the one single study visit
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during the one single study visit
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To examine the association between IMT value and cardiovascular disease (CVD) risk factors, and blood lipid and glucose profiles in middle-aged centrally obese subjects in Hong Kong.
Time Frame: During the one single study visit
|
During the one single study visit
|
|
IMT results to be compared with what being reported in the recent literature on normal Chinese population.
Time Frame: During the one single study visit
|
During the one single study visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Karen Yuen, AstraZeneca Hong Kong Ltd
- Principal Investigator: Chun chung Chow, MD, Prince of Wales Hospital, Shatin, Hong Kong
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
October 1, 2008
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
October 22, 2008
First Submitted That Met QC Criteria
October 31, 2008
First Posted (Estimate)
November 2, 2008
Study Record Updates
Last Update Posted (Estimate)
January 12, 2010
Last Update Submitted That Met QC Criteria
January 11, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-CHK-DUM-2008/1
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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