Acute Coronary SyndromeNCT01578616
Endothelial Dysfunction and Plaque Vulnerability
An observational study of Acute Coronary Syndrome, run by Yokohama City University Medical Center at 1 site in Japan.
Trial summary
Thinning of fibrous cap in atherosclerotic plaques is associated with plaque vulnerability. The high resolution of optical coherence tomography (OCT) provides an accurate measurement of fibrous cap thickness. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2010to May 2014
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Yokohama City University Medical Center
Who may be able to join
- patients with angiographically proven ACS (luminal stenosis of at least 50%) who undergo both OCT examination before coronary stent implantation and RH-PAT examination before discharge.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Japan1 site
Division of Cardiology, Yokohama City University Medical Center
Yokohama, 232-0024
About this study
Official title: Association of Endothelial Function With Plaque Vulnerability Assessed by Optical Coherence Tomography in Patients With Acute Coronary Syndrome
Thinning of fibrous cap in atherosclerotic plaques is associated with plaque vulnerability. The high resolution of optical coherence tomography (OCT) provides an accurate measurement of fibrous cap thickness. Endothelial dysfunction is a key component of vulnerable plaque and digital reactive hyperemia-peripheral arterial tonometry (RH-PAT) is a non-invasive automatic and quantitative method to evaluate endothelial function. The investigators will investigate the association between endothelial function assessed by RH-PAT and plaque vulnerability determined by OCT-derived thin-cap fibroatheroma (TCFA).
Read the detailed description
Consecutive patients with acute coronary syndrome (ACS) who undergo both OCT examination and RH-PAT examination are enrolled. OCT examination is performed to observe the culprit lesion before percutaneous coronary intervention, and endothelial function is evaluated using RH-PAT before discharge.
- Conditions
- Acute Coronary Syndrome
- Keywords
- Coronary artery disease, Endothelial function, Optical coherence tomography, Thin cap fibroatheroma
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease
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 |
|---|---|---|
| 3 / non-CAD, ACS with or without TCFA | ACS patients with thin cap fibroatheroma. ACS patients without thin cap fibroatheroma. Age-, gender-, and rate of hypertension or diabetes mellitus-matched patients who have never been diagnosed or treated for CAD are also enrolled as non-CAD patients | |
| non-CAD, ACS without TCFA, ACS with TCFA | Acute coronary syndrome (ACS) patients with thin cap fibroatheroma. ACS patients without thin cap fibroatheroma. Age-, gender-, and rate of hypertension or diabetes mellitus-matched patients who have never been diagnosed or treated for CAD are also enrolled as non-CAD patients |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startJul 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yokohama City University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiyoshi Hibi, Yokohama City University Medical Center
- Investigators
- Kiyoshi Hibi, MD, PhD, Principal investigator, Division of Cardiology, Yokohama City University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578616
- Sponsor's protocol ID
- RHI OCT study
- Status last verified
- Aug 2015
- First submitted
- 11 Apr 2012
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Endothelial Function With Plaque Vulnerability Assessed by Optical Coherence Tomography in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01578616
- Acronym / sponsor ID
- RHI OCT study
- Conditions
- Acute Coronary Syndrome
- Keywords
- Coronary artery disease, Endothelial function, Optical coherence tomography, Thin cap fibroatheroma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yokohama City University Medical CenterUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Apr 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.
Thinning of fibrous cap in atherosclerotic plaques is associated with plaque vulnerability. The high resolution of optical coherence tomography (OCT) provides an accurate measurement of fibrous cap thickness. Endothelial dysfunction is a key component of vulnerable plaque and digital reactive hyperemia-peripheral arterial tonometry (RH-PAT) is a non-invasive automatic and quantitative method to evaluate endothelial function. The investigators will investigate the association between endothelial function assessed by RH-PAT and plaque vulnerability determined by OCT-derived thin-cap fibroatheroma (TCFA).
Detailed description
Consecutive patients with acute coronary syndrome (ACS) who undergo both OCT examination and RH-PAT examination are enrolled. OCT examination is performed to observe the culprit lesion before percutaneous coronary intervention, and endothelial function is evaluated using RH-PAT before discharge.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 / non-CAD, ACS with or without TCFA | – | –ACS patients with thin cap fibroatheroma. ACS patients without thin cap fibroatheroma. Age-, gender-, and rate of hypertension or diabetes mellitus-matched patients who have never been diagnosed or treated for CAD are also enrolled as non-CAD patients |
| non-CAD, ACS without TCFA, ACS with TCFA | – | –Acute coronary syndrome (ACS) patients with thin cap fibroatheroma. ACS patients without thin cap fibroatheroma. Age-, gender-, and rate of hypertension or diabetes mellitus-matched patients who have never been diagnosed or treated for CAD are also enrolled as non-CAD patients |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Yokohama City University Medical Center
Key inclusion criteria (1 listed)
- patients with angiographically proven ACS (luminal stenosis of at least 50%) who undergo both OCT examination before coronary stent implantation and RH-PAT examination before discharge.
Key exclusion criteria (1 listed)
- none
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
Not reported in the source record.
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 7 Aug 2015.
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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.
Kiyoshi Hibi, MD, PhD principal investigator
Division of Cardiology, Yokohama City University Medical Center
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 Acute Coronary Syndrome, run by Yokohama City University Medical Center 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 1 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 7 Aug 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.
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 7 Aug 2015.