A Study to Derive Normative Distribution of CIMT and to Determine Its Correlation With Cardiovascular Risk Factors
Score-India
2 other identifiers
observational
1,200
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2012
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2012
CompletedFirst Posted
Study publicly available on registry
March 13, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJuly 9, 2013
July 1, 2013
1.2 years
March 7, 2012
July 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CIMT values in centimeters (unit) of male and female subjects without established cardiovascular disease.
at visit 1
Study Arms (1)
subjects who are meeting the inclusion criteria
Eligibility Criteria
Asymptomatic subjects with or without risk factors but not suffering from any established cardiovascular event.
You may qualify if:
- Provision of subject informed consent
- Female or male aged 30 years and over
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (24)
Research Site
Ahmedabad, Gujarat, India
Research Site
Vadodara, Gujarat, India
Research Site
Gurgaon, Haryana, India
Research Site
Keshwāpur, 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, Puducherry, India
Research Site
Jipur, Rajasthan, India
Research Site
Chennai, Tamil Nadu, India
Research Site
Poonkunnam, Thrisur, India
Research Site
Pattom, Trivandum, India
Research Site
Ghaziabad, Uttar Pradesh, India
Research Site
Noida, Uttar Pradesh, India
Research Site
Varanasi, 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
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Paurus M Irani, MD
AstraZeneca Pharma India Ltd.
- PRINCIPAL INVESTIGATOR
R R Kasliwal, DM
Medanta, The Medicity, Gurgaon
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2012
First Posted
March 13, 2012
Study Start
May 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
July 9, 2013
Record last verified: 2013-07