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

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.

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Key information

Conditions

Carotid Intima- Media Thickness Cardiovascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Ahmedabad, Gujarat, India

About this 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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

CIMT values in centimeters (unit) of male and female subjects without established cardiovascular disease.

Time frame: at visit 1

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: Score-India

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Mar 13, 2012
Registry last updated: Jul 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed