NCT00784264

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 3, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 12, 2010

Status Verified

January 1, 2010

First QC Date

October 22, 2008

Last Update Submit

January 11, 2010

Conditions

Keywords

Asymptomatic atherosclerosisIntima media thickness (IMT)central obesitycardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

  • IMT results to be compared with what being reported in the recent literature on normal Chinese population.

    During the one single study visit

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Male or female aged 55 years or above.
  • Waist circumference: male more than 90 cm; female more than 80 cm.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

AtherosclerosisObesity, AbdominalCardiovascular Diseases

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Karen Yuen

    AstraZeneca Hong Kong Ltd

    STUDY DIRECTOR
  • Chun chung Chow, MD

    Prince of Wales Hospital, Shatin, Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 22, 2008

First Posted

November 3, 2008

Study Start

October 1, 2008

Study Completion

June 1, 2009

Last Updated

January 12, 2010

Record last verified: 2010-01

Locations