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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01551875
First received: March 7, 2012
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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
Carotid Intima- Media Thickness

Study Type: Observational
Study Design: 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)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • CIMT values in centimeters (unit) of male and female subjects without established cardiovascular disease. [ Time Frame: at visit 1 ] [ Designated as safety issue: No ]

Enrollment: 1200
Study Start Date: May 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
subjects who are meeting the inclusion criteria

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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Asymptomatic subjects with or without risk factors but not suffering from any established cardiovascular event.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551875

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01551875     History of Changes
Other Study ID Numbers: NIS-CIN-XXX-2011/2, Score-India
Study First Received: March 7, 2012
Last Updated: July 8, 2013
Health Authority: India: Drugs Controller General of India

Keywords provided by AstraZeneca:
CIMT
cardiovascular disease
correlation with cardiovascular Risk factors

ClinicalTrials.gov processed this record on September 16, 2014