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A Study on Intima Media Thickness (IMT) in Middle-aged Subjects

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00784264
First received: October 22, 2008
Last updated: January 11, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition
Atherosclerosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Study on Intima Media Thickness (IMT) in Middle-aged Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2008
Study Completion Date: June 2009
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

aged 55 or above with central obesity, male more than 90 cm; female more than 80 cm

Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784264

Locations
Hong Kong
Research Site
Hong Kong, Hong Kong
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Karen Yuen AstraZeneca Hong Kong Ltd
Principal Investigator: Chun chung Chow, MD Prince of Wales Hospital, Shatin, Hong Kong
  More Information

No publications provided

Responsible Party: Karen Yuen, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00784264     History of Changes
Other Study ID Numbers: NIS-CHK-DUM-2008/1
Study First Received: October 22, 2008
Last Updated: January 11, 2010
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by AstraZeneca:
Asymptomatic atherosclerosis
Intima media thickness (IMT)
central obesity
cardiovascular disease

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013