A Study to Derive Normative Distribution of CIMT and to Determine Its Correlation With Cardiovascular Risk Factors

Overview

This non-interventional, prospective, multi-centric, cross-sectional study is aimed to obtain the distribution of measurements of CIMT in Indian subjects and will involve approx. 30 investigative sites from all over the country. Each investigative site will be expected to enrol 50 subjects and Carotid intima-media thickness (CIMT) values will be taken for each individual as described in the protocol. All the procedures could be completed in a single day, however due to any reason any study variable is not taken subject may be asked to come back for a second visit within 7 days of the first visit.

Full Title of Study: “A Study to Derive Normative Distribution of CIMT and to Determine Its Correlation With Cardiovascular Risk Factors in Asymptomatic Nationwide Indian Population (SCORE India)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2013

Detailed Description

A Study to derive normative distribution of CIMT and to determine its cOrrelation with cardiovascular Risk factors in asymptomatic nationwidE Indian population. (SCORE India)

Arms, Groups and Cohorts

  • subjects who are meeting the inclusion criteria

Clinical Trial Outcome Measures

Primary Measures

  • CIMT values in centimeters (unit) of male and female subjects without established cardiovascular disease.
    • Time Frame: at visit 1

Participating in This Clinical Trial

Inclusion Criteria

  • Provision of subject informed consent – Female or male aged 30 years and over Exclusion Criteria:

  • Subjects with established cardiovascular event – Intake of lipid lowering drug in the past 3 month – Subjects with known hypersensitivity to carotid bulb – Pregnant or lactating women

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Paurus M Irani, MD, Study Director, AstraZeneca Pharma India Ltd.
    • R R Kasliwal, DM, Principal Investigator, Medanta, The Medicity, Gurgaon

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.