AtherosclerosisNCT00795067
Relation of Circulating Endothelium-derived Microparticle to Carotid Atherosclerosis
An observational study of Atherosclerosis, run by Kurume University at 1 site in Japan.
Trial summary
The investigators hypothesized that circulating endothelium-derived microparticle (EMP) may be a useful surrogate marker of atherosclerosis and future episode of cerebrovascular events. Peripheral blood is drawn at the time of carotid ultrasound examination. Circulating EMPs are counted using flow-cytometry. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atherosclerosis
- How many people
- 154 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2008to Nov 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who undergo carotid ultrasound examination for screening of atheroscrelosis
Who may be able to join
- Patients who undergo carotid ultrasound examination for screening of atherosclerosis
Who cannot join
- Cerebrovascular events within the last 12 months
- Acute coronary syndrome, coronary and peripheral intervention within the last 6 months
- Uncontrolled heart failure
- Other severe systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesized that circulating endothelium-derived microparticle (EMP) may be a useful surrogate marker of atherosclerosis and future episode of cerebrovascular events. Peripheral blood is drawn at the time of carotid ultrasound examination. Circulating EMPs are counted using flow-cytometry. The correlation among circulating EMP, ultrasound findings, and atherosclerotic risk factors are determined by multiple stepwise regression analysis. The prevalence of cerebrovascular events is also determined during 3-year follow-up period.
- Conditions
- Atherosclerosis
- Medical subject headings
- Atherosclerosis
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 |
|---|---|---|
| Carotid atherosclerosis group | Patients who undergo carotid ultrasound examination for carotid atherosclerosis screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of circulating EMPs
Measured: at the time of carotid ultrasound examination
Secondary outcomes (1)
The occurrence of cerebrovascular and/or cardiovascular events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2010
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kurume University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisashi Kai, Kurume University
- Investigators
- Tsutomu Imaizumi, MD, PhD, Study chair, Kurume University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795067
- Sponsor's protocol ID
- KurumeU-08060
- Status last verified
- Mar 2015
- First submitted
- 20 Nov 2008
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Circulating Endothelium-derived Microparticle to Carotid Atherosclerosis
- ClinicalTrials.gov ID
- NCT00795067
- Acronym / sponsor ID
- KurumeU-08060
- Conditions
- Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Kurume UniversityUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 21 Nov 2008 (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 investigators hypothesized that circulating endothelium-derived microparticle (EMP) may be a useful surrogate marker of atherosclerosis and future episode of cerebrovascular events. Peripheral blood is drawn at the time of carotid ultrasound examination. Circulating EMPs are counted using flow-cytometry. The correlation among circulating EMP, ultrasound findings, and atherosclerotic risk factors are determined by multiple stepwise regression analysis. The prevalence of cerebrovascular events is also determined during 3-year follow-up period.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid atherosclerosis group | – | –Patients who undergo carotid ultrasound examination for carotid atherosclerosis screening |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo carotid ultrasound examination for screening of atheroscrelosis
Key inclusion criteria (1 listed)
- Patients who undergo carotid ultrasound examination for screening of atherosclerosis
Key exclusion criteria (4 listed)
- Cerebrovascular events within the last 12 months
- Acute coronary syndrome, coronary and peripheral intervention within the last 6 months
- Uncontrolled heart failure
- Other severe systemic diseases
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
The number of circulating EMPs
Time frame: at the time of carotid ultrasound examination
1 secondary outcome
The occurrence of cerebrovascular and/or cardiovascular events
Time frame: 3 years
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 31 Mar 2015.
Related trials for Atherosclerosis
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
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.
Tsutomu Imaizumi, MD, PhD study chair
Kurume University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by Kurume University at 1 site in Japan.
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 1 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 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
The number of circulating EMPs (time frame: at the time of carotid ultrasound examination). 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 31 Mar 2015.