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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01551875
Collaborator
(none)
1,200
Enrollment
24
Locations
14
Duration (Months)
50
Patients Per Site
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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)

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1200 participants
    Time Perspective:
    Prospective
    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 Start Date :
    May 1, 2012
    Actual Primary Completion Date :
    Jul 1, 2013
    Actual Study Completion Date :
    Jul 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    subjects who are meeting the inclusion criteria

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Ahmedabad Gujarat India
    2 Research Site Vadodara Gujarat India
    3 Research Site Gurgaon Haryana India
    4 Research Site Keshwapur Hubli India
    5 Research Site Nampally Hyderabad India
    6 Research Site Punjab Jalanhar India
    7 Research Site Bangalore Karnataka India
    8 Research Site Mangalore Karnataka India
    9 Research Site Mumbai Maharashtra India
    10 Research Site Nerul Navi Mumbai India
    11 Research Site Delhi New Delhi India
    12 Research Site Dhanvantri Nagar Pondicherry India
    13 Research Site Jipur Rajasthan India
    14 Research Site Chennai Tamil Nadu India
    15 Research Site Poonkunnam Thrisur India
    16 Research Site Pattom Trivandum India
    17 Research Site Noida UP India
    18 Research Site Varanasi UP India
    19 Research Site Ghaziabad Uttar Pradesh India
    20 Research Site Kolkata West Bengal India
    21 Research Site Chandigarh India
    22 Research Site Indore India
    23 Research Site Lucknow India
    24 Research Site Pune India

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Paurus M Irani, MD, AstraZeneca Pharma India Ltd.
    • Principal Investigator: R R Kasliwal, DM, Medanta, The Medicity, Gurgaon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT01551875
    Other Study ID Numbers:
    • NIS-CIN-XXX-2011/2
    • Score-India
    First Posted:
    Mar 13, 2012
    Last Update Posted:
    Jul 9, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by AstraZeneca
    CIMT
    cardiovascular disease
    correlation with cardiovascular Risk factors

    Study Results

    No Results Posted as of Jul 9, 2013