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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00970918
First Posted: September 3, 2009
Last Update Posted: September 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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.

Condition Intervention
Cardiovascular Disease Procedure: Measurement of the Carotid Intima Media thickness Biological: Blood sample testing for hs-CRP

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Screening
Official Title: Prevalence of Atherosclerotic Disease in Asian Subjects Not on Lipid-lowering Agents, But With at Least Two CVD Risk Factors

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 2609
Study Start Date: October 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970918


Locations
China, Beijing
Research Site
Beijing, Beijing, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
India
Research Site
Gurgaon, India
Research Site
Jaipur, India
Research Site
Meerut, India
Indonesia
Research Site
Denpasar, Bali, Indonesia
Research Site
Bandung-Jawa, Barat, Indonesia
Research Site
Semarang-Jawa, Tengah, Indonesia
Research Site
Surabaya, Timur, Indonesia
Korea, Republic of
Research Site
Seoul, Korea, Republic of
Malaysia
Research Site
Kuching, Sarawak, Malaysia
Philippines
Research Site
Manila, Philippines
Research Site
Quezon City, Philippines
Taiwan
Research Site
Kaohsiung, Taipei, Taiwan
Research Site
Shilin, Taipei, Taiwan
Research Site
Taoyuan, Taipei, Taiwan
Thailand
Research Site
Patumwan, Bangkok, Thailand
Vietnam
Research Site
Ho Chi Minh City, Ho Chi Min, Vietnam
Research Site
Hanoi, Vietnam
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Guy Yeoman, MD Asia Pacific Regional Office, AstraZeneca Singapore Pte Ltd 8 Wilkie Road, #07-01 Wilkie Edge, Singapore 228095
  More Information

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00970918     History of Changes
Other Study ID Numbers: D3560L00092
First Submitted: August 25, 2009
First Posted: September 3, 2009
Last Update Posted: September 24, 2010
Last Verified: September 2010

Keywords provided by AstraZeneca:
Cardiovascular disease
Carotid Intima Media Thickness

Additional relevant MeSH terms:
Cardiovascular Diseases