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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01551875

Acronym

Score-India

Enrollment

1200

Registered

2012-03-13

Start date

2012-05-31

Completion date

2013-07-31

Last updated

2013-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Intima- Media Thickness

Keywords

CIMT, cardiovascular disease, correlation with cardiovascular Risk factors

Brief summary

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.

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)

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

India

Outcome results