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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00784264
Other study ID # NIS-CHK-DUM-2008/1
Secondary ID
Status Completed
Phase N/A
First received October 22, 2008
Last updated January 11, 2010
Start date October 2008
Est. completion date June 2009

Study information

Verified date January 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date June 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 45 Years and older
Eligibility 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 Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Hong Kong Research Site Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary To investigate the prevalence of asymptomatic atherosclerosis by measurement of intima media thickness (IMT) in middle-aged subjects with central obesity in Hong Kong, during the one single study visit No
Secondary 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. During the one single study visit No
Secondary IMT results to be compared with what being reported in the recent literature on normal Chinese population. During the one single study visit No
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