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

Carotid Intima- Media Thickness Clinical Trial

— Score-India  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551875
• Other study ID #: NIS-CIN-XXX-2011/2
• Secondary ID: Score-India
• Status: Completed
• Phase: N/A
• First received: March 7, 2012
• Last updated: July 8, 2013
• Start date: May 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Carotid Intima- Media Thickness

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CIMT values in centimeters (unit) of male and female subjects without established cardiovascular disease.		at visit 1	No