Coronary Artery DiseaseNCT02966262
Korea University Anam Hospital Optical Coherence Tomography Registry
An observational study of Coronary Artery Disease and Optical Coherence Tomography, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
All comer registry who had undergone intravascular optical coherence tomography during and/or after coronary intervention. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Optical Coherence Tomography
- What is being tested?
- Optical coherence tomography
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Dec 2021
- How long will I take part?
- 10 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All comer registry with patients who had undergone coronary intervention and optical coherence tomography
Who may be able to join
- patients who had undergone coronary intervention and optical coherence tomography
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital
Seoul, 136-705
Cheol Woong Yu, M.D., Ph.D., +82-2-920-6726, ycw717@naver.com
About this study
Official title: Optical Coherence Tomography Registry of Korea University Anam Hospital
All comer registry who had undergone intravascular optical coherence tomography during and/or after coronary intervention.
Read the detailed description
Optical coherence tomography registry is composed with before coronary stenting, immediate after coronary stenting and follow-up study.
- Being tested
- Optical coherence tomography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomographyDevice
Intracoronary imaging device which can precisely observe intracoronary structures
| Study group | Role | What they receive |
|---|---|---|
| Optical Coherence Tomography registry group | Patients who had undergone optical coherence tomography within coronary intervention Receives: Device: Optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of participants with Major Adverse Cardiovascular Events (MACE)
Composite of non-fatal myocardial infarction, all cause death, target vessel revascularization
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Cheol Woong Yu, Korea University Anam Hospital
- Investigators
- Do-Sun Lim, MD, PhD, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966262
- Sponsor's protocol ID
- KUMC
- Status last verified
- Nov 2016
- First submitted
- 25 Apr 2016
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Registry of Korea University Anam Hospital
- ClinicalTrials.gov ID
- NCT02966262
- Acronym / sponsor ID
- KUMC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Nov 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.
All comer registry who had undergone intravascular optical coherence tomography during and/or after coronary intervention.
Detailed description
Optical coherence tomography registry is composed with before coronary stenting, immediate after coronary stenting and follow-up study.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optical Coherence Tomography registry group | – | Device: Optical coherence tomographyPatients who had undergone optical coherence tomography within coronary intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All comer registry with patients who had undergone coronary intervention and optical coherence tomography
Key inclusion criteria (1 listed)
- patients who had undergone coronary intervention and optical coherence tomography
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical coherence tomographyIntracoronary imaging device which can precisely observe intracoronary structures | Device | Optical Coherence Tomography registry group |
Primary outcome
Incidence of participants with Major Adverse Cardiovascular Events (MACE)
Time frame: Up to 10 years
Composite of non-fatal myocardial infarction, all cause death, target vessel revascularization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Do-Sun Lim, MD, PhD principal investigator
Korea University Anam Hospital
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 Coronary Artery Disease and Optical Coherence Tomography, run by Korea University Anam Hospital 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 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: status not confirmed, as of the sponsor's last update on 17 Nov 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheol Woong Yu, MD, PhD (8229205445, ycw717@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of participants with Major Adverse Cardiovascular Events (MACE) (time frame: Up to 10 years). 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 17 Nov 2016.