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

Cardiovascular Disease Clinical Trial

— CIMT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970918
• Other study ID #: D3560L00092
• Status: Completed
• Phase: N/A
• First received: August 25, 2009
• Last updated: September 22, 2010
• Start date: October 2009
• Est. completion date: August 2010

Study information

• Verified date: September 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaIndonesia: Departement Kesehatan (Department of Health)Indonesia: Komite Etik - Ethical CommitteeIndonesia: National Agency of Drug and Food ControlKorea: Institutional Review BoardMalaysia: Ministry of HealthPhilippines: Bureau of Food and DrugsSingapore: Health Sciences AuthorityTaiwan: Institutional Review BoardThailand: Ethical CommitteeVietnam: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2609
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 69 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Primary Purpose: Screening

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

China,  India,  Indonesia,  Korea, Republic of,  Malaysia,  Philippines,  Taiwan,  Thailand,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Carotid Intima Media Thickness of people with high risk of cardiovascular disease but not on lipid lowering drugs		IIMT measurements taken only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months)	No
Secondary	Lipid profile of people with high risk of cardiovascular disease but not on lipid lowering drugs		Blood sampling only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months)	No