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

NCT ID: NCT01551875

Last Updated: 2013-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-07-31

Brief Summary

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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

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A Study to derive normative distribution of CIMT and to determine its cOrrelation with cardiovascular Risk factors in asymptomatic nationwidE Indian population. (SCORE India)

Conditions

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Carotid Intima- Media Thickness

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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subjects who are meeting the inclusion criteria

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paurus M Irani, MD

Role: STUDY_DIRECTOR

AstraZeneca Pharma India Ltd.

R R Kasliwal, DM

Role: PRINCIPAL_INVESTIGATOR

Medanta, The Medicity, Gurgaon

Locations

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Research Site

Ahmedabad, Gujarat, India

Site Status

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Vadodara, Gujarat, India

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Gurgaon, Haryana, India

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Keshwāpur, Hubli, India

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Nampally, Hyderabad, India

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Punjab, Jalanhar, India

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Bangalore, Karnataka, India

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Mangalore, Karnataka, India

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Mumbai, Maharashtra, India

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Nerul, Navi Mumbai, India

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Delhi, New Delhi, India

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Dhanvantri Nagar, Puducherry, India

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Jipur, Rajasthan, India

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Chennai, Tamil Nadu, India

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Poonkunnam, Thrisur, India

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Pattom, Trivandum, India

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Ghaziabad, Uttar Pradesh, India

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Noida, Uttar Pradesh, India

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Varanasi, Uttar Pradesh, India

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Kolkata, West Bengal, India

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Chandigarh, , India

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Indore, , India

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Lucknow, , India

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Pune, , India

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Countries

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India

Other Identifiers

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Score-India

Identifier Type: -

Identifier Source: secondary_id

NIS-CIN-XXX-2011/2

Identifier Type: -

Identifier Source: org_study_id

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