A Study to Derive Normative Distribution of CIMT and to Determine Its Correlation With Cardiovascular Risk Factors (Score-India)

July 8, 2013 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

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)

Study Type

Observational

Enrollment (Actual)

1200

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

  • India
      • Chandigarh, India
        • Research Site
      • Indore, India
        • Research Site
      • Lucknow, India
        • Research Site
      • Pune, India
        • Research Site
    • Gujarat
      • Ahmedabad, Gujarat, India
        • Research Site
      • Vadodara, Gujarat, India
        • Research Site
    • Haryana
      • Gurgaon, Haryana, India
        • Research Site
    • Hubli
      • Keshwapur, Hubli, India
        • Research Site
    • Hyderabad
      • Nampally, Hyderabad, India
        • Research Site
    • Jalanhar
      • Punjab, Jalanhar, India
        • Research Site
    • Karnataka
      • Bangalore, Karnataka, India
        • Research Site
      • Mangalore, Karnataka, India
        • Research Site
    • Maharashtra
      • Mumbai, Maharashtra, India
        • Research Site
    • Navi Mumbai
      • Nerul, Navi Mumbai, India
        • Research Site
    • New Delhi
      • Delhi, New Delhi, India
        • Research Site
    • Pondicherry
      • Dhanvantri Nagar, Pondicherry, India
        • Research Site
    • Rajasthan
      • Jipur, Rajasthan, India
        • Research Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India
        • Research Site
    • Thrisur
      • Poonkunnam, Thrisur, India
        • Research Site
    • Trivandum
      • Pattom, Trivandum, India
        • Research Site
    • UP
      • Noida, UP, India
        • Research Site
      • Varanasi, UP, India
        • Research Site
    • Uttar Pradesh
      • Ghaziabad, Uttar Pradesh, India
        • Research Site
    • West Bengal
      • Kolkata, West Bengal, India
        • 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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Asymptomatic subjects with or without risk factors but not suffering from any established cardiovascular event.

Description

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

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

Cohorts and Interventions

Group / Cohort
subjects who are meeting the inclusion criteria

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Paurus M Irani, MD, AstraZeneca Pharma India Ltd.

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

May 1, 2012

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

March 7, 2012

First Submitted That Met QC Criteria

March 9, 2012

First Posted (ESTIMATE)

March 13, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 9, 2013

Last Update Submitted That Met QC Criteria

July 8, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NIS-CIN-XXX-2011/2
  • Score-India

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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