NCT00970918

Brief 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.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
2,609

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable

Geographic Reach
9 countries

19 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 3, 2009

Completed
28 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

September 24, 2010

Status Verified

September 1, 2010

Enrollment Period

10 months

First QC Date

August 25, 2009

Last Update Submit

September 22, 2010

Conditions

Keywords

Cardiovascular diseaseCarotid Intima Media Thickness

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • 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)

Study Arms (1)

1

EXPERIMENTAL
Procedure: Measurement of the Carotid Intima Media thicknessBiological: Blood sample testing for hs-CRP

Interventions

one time, radiological procedure on both sides of the neck

1

one time, blood sample taking

1

Eligibility Criteria

Age30 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Research Site

Beijing, Beijing Municipality, China

Location

Research Site

Shanghai, Shanghai Municipality, China

Location

Research Site

Gūrgaon, India

Location

Research Site

Jaipur, India

Location

Research Site

Meerut, India

Location

Research Site

Denpasar, Bali, Indonesia

Location

Research Site

Bandung-Jawa, Barat, Indonesia

Location

Research Site

Semarang-Jawa, Tengah, Indonesia

Location

Research Site

Surabaya, Timur, Indonesia

Location

Research Site

Kuching, Sarawak, Malaysia

Location

Research Site

Manila, Manila, Philippines

Location

Research Site

Quezon City, Philippines

Location

Research Site

Seoul, Seoul, South Korea

Location

Research Site

Kaohsiung, Taipei, Taiwan

Location

Research Site

Shilin, Taipei, Taiwan

Location

Research Site

Taoyuan, Taipei, Taiwan

Location

Research Site

Patumwan, Bangkok, Thailand

Location

Research Site

Hanoi, Hanoi, Vietnam

Location

Research Site

Ho Chi Minh City, Ho Chi Min, Vietnam

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

C-Reactive Protein

Intervention Hierarchy (Ancestors)

AlbuminsProteinsAmino Acids, Peptides, and ProteinsAcute-Phase ProteinsBlood ProteinsImmunoproteins

Study Officials

  • Guy Yeoman, MD

    Asia Pacific Regional Office, AstraZeneca Singapore Pte Ltd 8 Wilkie Road, #07-01 Wilkie Edge, Singapore 228095

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 25, 2009

First Posted

September 3, 2009

Study Start

October 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

September 24, 2010

Record last verified: 2010-09

Locations