Atherosclerotic PlaqueOCT pathologyNCT02649881
Diagnosis of Macrophage Coronary Plaque by Optical Tomographic Imaging
An observational study of Atherosclerotic Plaque, run by Young-Hak Kim, MD, PhD at 1 site in South Korea.
Trial summary
This study evaluated optimal macrophage diagnosis algorithm through comparative analysis between coronary artery, OCT image, and IVUS, and improve a diagnosis rate of vulnerable coronary plaque accompanied with macrophage infiltration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Plaque
- What is being tested?
- The heart subject will undergo OCT
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 May 2015to 31 Aug 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is targeted at the isolated heart voluntarily donated from adult patients who receive heart transplantation
Who may be able to join
- Age 18 and above
- Patients who are to receive heart transplantation
- Patients or their legal representatives who gave a prior written consent
Who cannot join
- Impossible to OCT and IVUS analysis due to severe coronary stenosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnosis of Macrophage Coronary Plaque by Optical Tomographic Imaging : A Comparative Study With Coronary Artery of the Transplanted or Autopsy Heart
This study evaluated optimal macrophage diagnosis algorithm through comparative analysis between coronary artery, OCT image, and IVUS, and improve a diagnosis rate of vulnerable coronary plaque accompanied with macrophage infiltration.
- Conditions
- Atherosclerotic Plaque
- Being tested
- The heart subject will undergo OCT
- Keywords
- macrophage, vulnerable coronary plaque
- Medical subject headings
- Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The heart subject will undergo OCTProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| isolated heart from heart transplantation | Not described Receives: Procedure: The heart subject will undergo OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROC curve of diagnosis
Receiver Operating Characteristic curve of diagnosis through existing NSD(normalized standard deviation)-based method and developed algorithm in the diagnosis of coronary plaque accompanied with macrophage infiltration
Measured: within 48 hours
Secondary outcomes (5)
fibrin accumulation
Measured: within 48 hours
neoatherosclerosis
Measured: within 48 hours
elastic lamia
Measured: within 48 hours
cholesterol crystal
Measured: within 48 hours
microcalcification
Measured: within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study start12 May 2015
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic PlaqueStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Young-Hak Kim, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Young-Hak Kim, MD, PhD, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649881
- Sponsor's protocol ID
- AMCCV2015-03
- Acronym
- OCT pathology
- Status last verified
- Sep 2018
- First submitted
- 6 Jan 2016
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: This is not publicly funded trial.
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Macrophage Coronary Plaque by Optical Tomographic Imaging : A Comparative Study With Coronary Artery of the Transplanted or Autopsy Heart
- ClinicalTrials.gov ID
- NCT02649881
- Acronym / sponsor ID
- OCT pathology / AMCCV2015-03
- Conditions
- Atherosclerotic Plaque
- Keywords
- macrophage, vulnerable coronary plaque
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Young-Hak Kim, MD, PhDUniversity, hospital or other
- Study start
- 12 May 2015 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 8 Jan 2016 (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 study evaluated optimal macrophage diagnosis algorithm through comparative analysis between coronary artery, OCT image, and IVUS, and improve a diagnosis rate of vulnerable coronary plaque accompanied with macrophage infiltration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| isolated heart from heart transplantation | – | Procedure: The heart subject will undergo OCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is targeted at the isolated heart voluntarily donated from adult patients who receive heart transplantation
Key inclusion criteria (3 listed)
- Age 18 and above
- Patients who are to receive heart transplantation
- Patients or their legal representatives who gave a prior written consent
Key exclusion criteria (1 listed)
- Impossible to OCT and IVUS analysis due to severe coronary stenosis
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 |
|---|---|---|
| The heart subject will undergo OCT | Procedure or surgery | isolated heart from heart transplantation |
Primary outcome
ROC curve of diagnosis
Time frame: within 48 hours
Receiver Operating Characteristic curve of diagnosis through existing NSD(normalized standard deviation)-based method and developed algorithm in the diagnosis of coronary plaque accompanied with macrophage infiltration
5 secondary outcomes
fibrin accumulation
Time frame: within 48 hours
neoatherosclerosis
Time frame: within 48 hours
elastic lamia
Time frame: within 48 hours
cholesterol crystal
Time frame: within 48 hours
microcalcification
Time frame: within 48 hours
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 6 Sep 2018.
- Individual participant dataSharing planned: No. This is not publicly funded trial.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Atherosclerotic Plaque, run by Young-Hak Kim, MD, PhD at 1 site in South Korea.
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 3 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 6 Sep 2018. 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 South Korea. 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?
ROC curve of diagnosis (time frame: within 48 hours). 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 6 Sep 2018.