Study of Artery Conditions of 'At-risk' Asian People Not on Lipid-lowering Drugs (CIMT)

September 22, 2010 updated by: AstraZeneca

Prevalence of Atherosclerotic Disease in Asian Subjects Not on Lipid-lowering Agents, But With at Least Two CVD Risk Factors

The purpose of this study is to obtain the distribution of measurements of the intima media thickness of carotid arteries in people with high cardiovascular risk.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2609

Phase

  • Not Applicable

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

  • China
    • Beijing
      • Beijing, Beijing, China
        • Research Site
    • Shanghai
      • Shanghai, Shanghai, China
        • Research Site
  • India
      • Gurgaon, India
        • Research Site
      • Jaipur, India
        • Research Site
      • Meerut, India
        • Research Site
  • Indonesia
    • Bali
      • Denpasar, Bali, Indonesia
        • Research Site
    • Barat
      • Bandung-Jawa, Barat, Indonesia
        • Research Site
    • Tengah
      • Semarang-Jawa, Tengah, Indonesia
        • Research Site
    • Timur
      • Surabaya, Timur, Indonesia
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Research Site
  • Malaysia
    • Sarawak
      • Kuching, Sarawak, Malaysia
        • Research Site
  • Philippines
      • Manila, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
  • Taiwan
    • Taipei
      • Kaohsiung, Taipei, Taiwan
        • Research Site
      • Shilin, Taipei, Taiwan
        • Research Site
      • Taoyuan, Taipei, Taiwan
        • Research Site
  • Thailand
    • Bangkok
      • Patumwan, Bangkok, Thailand
        • Research Site
  • Vietnam
      • Hanoi, Vietnam
        • Research Site
    • Ho Chi Min
      • Ho Chi Minh City, Ho Chi Min, Vietnam
        • Research Site

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

30 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of signed informed consent.
  • Patients with at least two CVD risk factors but not on lipid-lowering agents

Exclusion Criteria:

  • Subjects with CHD, any conditions that may affect hs-CRP levels.
  • Subjects on any lipid-lowering drug treatment within the last 3 months prior study entry.

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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Procedure: Measurement of the Carotid Intima Media thickness
one time, radiological procedure on both sides of the neck
Biological: Blood sample testing for hs-CRP
one time, blood sample taking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of Carotid Intima Media Thickness of people with high risk of cardiovascular disease but not on lipid lowering drugs
Time Frame: IIMT measurements taken only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months)
IIMT measurements taken only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Lipid profile of people with high risk of cardiovascular disease but not on lipid lowering drugs
Time Frame: Blood sampling only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months)
Blood sampling only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Guy Yeoman, MD, Asia Pacific Regional Office, AstraZeneca Singapore Pte Ltd 8 Wilkie Road, #07-01 Wilkie Edge, Singapore 228095

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, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

August 25, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (Estimate)

September 3, 2009

Study Record Updates

Last Update Posted (Estimate)

September 24, 2010

Last Update Submitted That Met QC Criteria

September 22, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3560L00092

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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