Coronary Artery DiseaseSMC-PCINCT05624905
Prospective Pecutaneous Coronary Intervention Registry
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Coronary artery disease is the most important cause of death worldwide. Treatment option for coronary artery disease is medical treatment, percutaneous coronary intervention, or coronary artery bypass surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 15,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Mar 2016to 31 Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients who underwent coronary angiography adn percutaneous coronary intervention
Who may be able to join
- patients who have undergone or are scheduled to undergo coronary angiography and percutaneous coronary intervention.
Who cannot join
- patients who did not consent to the research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Joo-Yong Hahn, MD, PhD, 82-2-3410-6653, jyhahn@skku.edu
Ki Hong Choi, MD, PhD, 82-2-3410-2575, cardiokh@gmail.com
About this study
Official title: Prospective Registry for Identifying Long-term Prognosis in Patients Who Underwent Coronary Angiography and Percutaneous Coronary Intervention for Coronary Artery Disease
Coronary artery disease is the most important cause of death worldwide. Treatment option for coronary artery disease is medical treatment, percutaneous coronary intervention, or coronary artery bypass surgery. Among them, the field of percutaneous coronary intervention is rapidly developing with regard to the improvement of devices, techniques, or medical treatment, leading to reduce mortality or morbidity. Until now, numerous previous studies related to the risk factors of coronary artery disease and the prognosis of patients have been conducted. However, the field of percutaneous coronary intervention is rapidly evolving, and treatment strategies are constantly being updated. Therefore, the current study sought to identify the long-term prognosis and related risk factors of patients with coronary artery disease who underwent percutaneous coronary intervention.
- Being tested
- Percutaneous coronary intervention
- 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.
Percutaneous coronary interventionProcedure or surgery
Percutaneous Coronary Intervention Procedure
| Study group | Role | What they receive |
|---|---|---|
| PCI group | All consecutive patients with coronary artery disease who underwent percutaneous coronary intervention Receives: Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Cardiac death or Target-vessel myocardial infarction
A composite of cardiac death or target vessel myocardial infarction
Measured: up to 10 years
Rates of Major adverse cardiac and cerebrovascular event
A composite of all-cause death, myocardial infarction, cerebrovascular accident, or repeat revascularization
Measured: up to 10 years
Secondary outcomes (8)
Rates of all-cause death
Death from any cause
Measured: up to 10 years
Rates of cardiac death
Death from cardiac cause
Measured: up to 10 years
Rates of myocardial infarction
Any myocardial infarction
Measured: up to 10 years
Rates of target-vessel myocardial infarction
target-vessel myocardial infarction
Measured: up to 10 years
Rates of target lesion revascularization
target lesion revascularization
Measured: up to 10 years
Rates of target vessel revascularization
target vessel revascularization
Measured: up to 10 years
Rates of cerebrovascular accident
ischemic or hemorrhagic stroke
Measured: up to 10 years
Rates of stent thrombosis
definite or probable stent thrombosis
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 posted22 Nov 2022
- Study start20 Mar 2016
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joo-Yong Hahn, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624905
- Sponsor's protocol ID
- SMC-PCI
- Acronym
- SMC-PCI
- Status last verified
- Aug 2024
- First submitted
- 15 Nov 2022
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi KH, Lee SY, Song YB, Park TK, Lee JM, Yang JH, Choi JH, Choi SH, Gwon HC, Hahn JY. Prognostic Impact of Operator Experience and IVUS Guidance on Long-Term Clinical Outcomes After Complex PCI. JACC Cardiovasc Interv. 2023 Jul 24;16(14):1746-1758. doi: 10.1016/j.jcin.2023.04.022.
PubMed 37495350
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry for Identifying Long-term Prognosis in Patients Who Underwent Coronary Angiography and Percutaneous Coronary Intervention for Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05624905
- Acronym / sponsor ID
- SMC-PCI / SMC-PCI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 20 Mar 2016 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Nov 2022 (actual)
- 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.
Coronary artery disease is the most important cause of death worldwide. Treatment option for coronary artery disease is medical treatment, percutaneous coronary intervention, or coronary artery bypass surgery. Among them, the field of percutaneous coronary intervention is rapidly developing with regard to the improvement of devices, techniques, or medical treatment, leading to reduce mortality or morbidity. Until now, numerous previous studies related to the risk factors of coronary artery disease and the prognosis of patients have been conducted. However, the field of percutaneous coronary intervention is rapidly evolving, and treatment strategies are constantly being updated. Therefore, the current study sought to identify the long-term prognosis and related risk factors of patients with coronary artery disease who underwent percutaneous coronary intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCI group | – | Procedure: Percutaneous coronary interventionAll consecutive patients with coronary artery disease who underwent percutaneous coronary intervention |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients who underwent coronary angiography adn percutaneous coronary intervention
Key inclusion criteria (1 listed)
- patients who have undergone or are scheduled to undergo coronary angiography and percutaneous coronary intervention.
Key exclusion criteria (1 listed)
- patients who did not consent to the research
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 |
|---|---|---|
| Percutaneous coronary interventionPercutaneous Coronary Intervention Procedure | Procedure or surgery | PCI group |
Primary outcome
Rates of Cardiac death or Target-vessel myocardial infarction
Time frame: up to 10 years
A composite of cardiac death or target vessel myocardial infarction
Rates of Major adverse cardiac and cerebrovascular event
Time frame: up to 10 years
A composite of all-cause death, myocardial infarction, cerebrovascular accident, or repeat revascularization
8 secondary outcomes
Rates of all-cause death
Time frame: up to 10 years
Rates of cardiac death
Time frame: up to 10 years
Rates of myocardial infarction
Time frame: up to 10 years
Rates of target-vessel myocardial infarction
Time frame: up to 10 years
Rates of target lesion revascularization
Time frame: up to 10 years
Rates of target vessel revascularization
Time frame: up to 10 years
Rates of cerebrovascular accident
Time frame: up to 10 years
Rates of stent thrombosis
Time frame: up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Derived from this study: PubMed 37495350Choi KH, Lee SY, Song YB, Park TK, Lee JM, Yang JH, Choi JH, Choi SH, Gwon HC, Hahn JY. Prognostic Impact of Operator Experience and IVUS Guidance on Long-Term Clinical Outcomes After Complex PCI. JACC Cardiovasc Interv. 2023 Jul 24;16(14):1746-1758. doi: 10.1016/j.jcin.2023.04.022.
- 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.
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 Percutaneous Coronary Intervention, run by Samsung Medical Center 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: looking for participants now, as of the sponsor's last update on 14 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joo-Yong Hahn, MD (82-2-3410-3419, jyhahn@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Cardiac death or Target-vessel myocardial infarction (time frame: up to 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05624905, which also lists 1 linked publication.
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 14 Aug 2024.