Cardiovascular DiseaseCIMTNCT00970918
Study of Artery Conditions of 'At-risk' Asian People Not on Lipid-lowering Drugs
A study testing Measurement of the Carotid Intima Media thickness and Blood sample testing for hs-CRP in people with Cardiovascular Disease, run by AstraZeneca at 19 sites in 9 countries.
Trial summary
The purpose of this study is to obtain the distribution of measurements of the intima media thickness of carotid arteries in people with high cardiovascular risk. Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Measurement of the Carotid Intima Media thickness and Blood sample testing for hs-CRP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,609 participants
- Where
- 19 sitesin 9 countries
- Study dates
- Oct 2009to Aug 2010
- Phase
- Interventional
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed informed consent.
- Patients with at least two CVD risk factors but not on lipid-lowering agents
Who cannot join
- Subjects with CHD, any conditions that may affect hs-CRP levels.
- Subjects on any lipid-lowering drug treatment within the last 3 months prior study entry.
Trial locations and contacts
19 sites in 9 countries.
19 sites in 9 countries
Indonesia4 sites
Research Site
Bandung-Jawa, Barat
Research Site
Denpasar, Bali
Research Site
Semarang-Jawa, Tengah
Research Site
Surabaya, Timur
Taiwan3 sites
Research Site
Kaohsiung, Taipei
Research Site
Shilin, Taipei
Research Site
Taoyuan, Taipei
China2 sites
Research Site
Beijing, Beijing Municipality
Research Site
Shanghai, Shanghai Municipality
Vietnam2 sites
Research Site
Hanoi, Hanoi
Research Site
Ho Chi Minh City, Ho Chi Min
About this study
Official title: Prevalence of Atherosclerotic Disease in Asian Subjects Not on Lipid-lowering Agents, But With at Least Two CVD Risk Factors
The purpose of this study is to obtain the distribution of measurements of the intima media thickness of carotid arteries in people with high cardiovascular risk.
- Conditions
- Cardiovascular Disease
- Being tested
- Measurement of the Carotid Intima Media thickness, Blood sample testing for hs-CRP
- Keywords
- Cardiovascular disease, Carotid Intima Media Thickness
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of the Carotid Intima Media thicknessProcedure or surgery
one time, radiological procedure on both sides of the neck
Blood sample testing for hs-CRPBiological
one time, blood sample taking
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: Measurement of the Carotid Intima Media thickness; Biological: Blood sample testing for hs-CRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Carotid Intima Media Thickness of people with high risk of cardiovascular disease but not on lipid lowering drugs
Measured: IIMT measurements taken only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months)
Secondary outcomes (1)
Lipid profile of people with high risk of cardiovascular disease but not on lipid lowering drugs
Measured: Blood sampling only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 2,609 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Guy Yeoman, MD, Study director, Asia Pacific Regional Office, AstraZeneca Singapore Pte Ltd 8 Wilkie Road, #07-01 Wilkie Edge, Singapore 228095
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970918
- Sponsor's protocol ID
- D3560L00092
- Acronym
- CIMT
- Status last verified
- Sep 2010
- First submitted
- 25 Aug 2009
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Atherosclerotic Disease in Asian Subjects Not on Lipid-lowering Agents, But With at Least Two CVD Risk Factors
- ClinicalTrials.gov ID
- NCT00970918
- Acronym / sponsor ID
- CIMT / D3560L00092
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular disease, Carotid Intima Media Thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,609 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 3 Sep 2009 (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.
The purpose of this study is to obtain the distribution of measurements of the intima media thickness of carotid arteries in people with high cardiovascular risk.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Measurement of the Carotid Intima Media thickness, Biological: Blood sample testing for hs-CRP |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Provision of signed informed consent.
- Patients with at least two CVD risk factors but not on lipid-lowering agents
Key exclusion criteria (2 listed)
- Subjects with CHD, any conditions that may affect hs-CRP levels.
- Subjects on any lipid-lowering drug treatment within the last 3 months prior study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of the Carotid Intima Media thicknessone time, radiological procedure on both sides of the neck | Procedure or surgery | 1 |
| Blood sample testing for hs-CRPone time, blood sample taking | Biological | 1 |
Primary outcome
Measurement of Carotid Intima Media Thickness of people with high risk of cardiovascular disease but not on lipid lowering drugs
Time frame: IIMT measurements taken only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months)
1 secondary outcome
Lipid profile of people with high risk of cardiovascular disease but not on lipid lowering drugs
Time frame: Blood sampling only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months)
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 24 Sep 2010.
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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.
Guy Yeoman, MD study director
Asia Pacific Regional Office, AstraZeneca Singapore Pte Ltd 8 Wilkie Road, #07-01 Wilkie Edge, Singapore 228095
19 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of the Carotid Intima Media thickness and Blood sample testing for hs-CRP in people with Cardiovascular Disease, run by AstraZeneca at 19 sites in 9 countries.
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 2 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 24 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Indonesia, India, Taiwan, China, Philippines and 4 more countries. 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?
Measurement of Carotid Intima Media Thickness of people with high risk of cardiovascular disease but not on lipid lowering drugs (time frame: IIMT measurements taken only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months)). 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 24 Sep 2010.