Clinical trial NCT01551875: A Study to Derive Normative Distribution of CIMT and to Determine Its Correlation With Cardiovascular Risk Factors
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Intima- Media Thickness
Keywords: CIMT
cardiovascular disease
correlation with cardiovascular Risk factors
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-03-13
Enrollment: 1200
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asymptomatic subjects with or without risk factors but not suffering from any established cardiovascular event.

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)

Eligibility criteria: 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

Primary outcomes:
measure: CIMT values in centimeters (unit) of male and female subjects without established cardiovascular disease.
timeFrame: at visit 1
Secondary outcomes:
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Research Site
state: Gujarat
city: Vadodara
country: India
facility: Research Site
state: Gujarat
city: Gurgaon
country: India
facility: Research Site
state: Haryana
city: Keshwapur
country: India
facility: Research Site
state: Hubli
city: Nampally
country: India
facility: Research Site
state: Hyderabad
city: Punjab
country: India
facility: Research Site
state: Jalanhar
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Mangalore
country: India
facility: Research Site
state: Karnataka
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Nerul
country: India
facility: Research Site
state: Navi Mumbai
city: Delhi
country: India
facility: Research Site
state: New Delhi
city: Dhanvantri Nagar
country: India
facility: Research Site
state: Pondicherry
city: Jipur
country: India
facility: Research Site
state: Rajasthan
city: Chennai
country: India
facility: Research Site
state: Tamil Nadu
city: Poonkunnam
country: India
facility: Research Site
state: Thrisur
city: Pattom
country: India
facility: Research Site
state: Trivandum
city: Noida
country: India
facility: Research Site
state: UP
city: Varanasi
country: India
facility: Research Site
state: UP
city: Ghaziabad
country: India
facility: Research Site
state: Uttar Pradesh
city: Kolkata
country: India
facility: Research Site
state: West Bengal
city: Chandigarh
country: India
facility: Research Site
city: Indore
country: India
facility: Research Site
city: Lucknow
country: India
facility: Research Site
city: Pune
country: India
facility: Research Site
Study officials:
affiliation: AstraZeneca Pharma India Ltd.
name: Paurus M Irani, MD
role: STUDY_DIRECTOR
affiliation: Medanta, The Medicity, Gurgaon
name: R R Kasliwal, DM
role: PRINCIPAL_INVESTIGATOR
References: