A Study to Derive Normative Distribution of CIMT and to Determine Its Correlation With Cardiovascular Risk Factors
- Conditions
- Carotid Intima- Media Thickness
- Registration Number
- NCT01551875
- Lead Sponsor
- AstraZeneca
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1200
- Provision of subject informed consent
- Female or male aged 30 years and over
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CIMT values in centimeters (unit) of male and female subjects without established cardiovascular disease. at visit 1
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇮🇳Pune, India