Carotid Intima- Media ThicknessScore-IndiaNCT01551875
A Study to Derive Normative Distribution of CIMT and to Determine Its Correlation With Cardiovascular Risk Factors
An observational study of Carotid Intima- Media Thickness, run by AstraZeneca at 24 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carotid Intima- Media Thickness
- How many people
- 1,200 participants
- Where
- 24 sitesIndia
- Study dates
- May 2012to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Asymptomatic subjects with or without risk factors but not suffering from any established cardiovascular event.
Who may be able to join
- Provision of subject informed consent
- Female or male aged 30 years and over
Who cannot join
- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
India24 sites
Research Site
Ahmedabad, Gujarat
Research Site
Bangalore, Karnataka
Research Site
Chandigarh
Research Site
Chennai, Tamil Nadu
Research Site
Delhi, New Delhi
Research Site
Dhanvantri Nagar, Puducherry
Research Site
Ghaziabad, Uttar Pradesh
Research Site
Gurgaon, Haryana
Research Site
Indore
Research Site
Jipur, Rajasthan
Research Site
Keshwāpur, Hubli
Research Site
Kolkata, West Bengal
Research Site
Lucknow
Research Site
Mangalore, Karnataka
Research Site
Mumbai, Maharashtra
Research Site
Nampally, Hyderabad
Research Site
Nerul, Navi Mumbai
Research Site
Noida, Uttar Pradesh
Research Site
Pattom, Trivandum
Research Site
Poonkunnam, Thrisur
Research Site
Pune
Research Site
Punjab, Jalanhar
Research Site
Vadodara, Gujarat
Research Site
Varanasi, Uttar Pradesh
About this study
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)
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.
Read the 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)
- Conditions
- Carotid Intima- Media Thickness
- Keywords
- CIMT, cardiovascular disease, correlation with cardiovascular Risk factors
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| subjects who are meeting the inclusion criteria | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
CIMT values in centimeters (unit) of male and female subjects without established cardiovascular disease.
Measured: at visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Intima- Media ThicknessStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paurus M Irani, MD, Study director, AstraZeneca Pharma India Ltd.R R Kasliwal, DM, Principal investigator, Medanta, The Medicity, Gurgaon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551875
- Sponsor's protocol ID
- NIS-CIN-XXX-2011/2
- Other IDs
- Score-India
- Acronym
- Score-India
- Status last verified
- Jul 2013
- First submitted
- 7 Mar 2012
- Last updated
- 9 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01551875
- Acronym / sponsor ID
- Score-India / NIS-CIN-XXX-2011/2
- Conditions
- Carotid Intima- Media Thickness
- Keywords
- CIMT, cardiovascular disease, correlation with cardiovascular Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects who are meeting the inclusion criteria | – | – |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Asymptomatic subjects with or without risk factors but not suffering from any established cardiovascular event.
Key inclusion criteria (2 listed)
- Provision of subject informed consent
- Female or male aged 30 years and over
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CIMT values in centimeters (unit) of male and female subjects without established cardiovascular disease.
Time frame: at visit 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paurus M Irani, MD study director
AstraZeneca Pharma India Ltd.
R R Kasliwal, DM principal investigator
Medanta, The Medicity, Gurgaon
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Intima- Media Thickness, run by AstraZeneca at 24 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIMT values in centimeters (unit) of male and female subjects without established cardiovascular disease. (time frame: at visit 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2013; AzTrials last refreshed its copy on 26 Oct 2026.