Coronary Artery StenosisHYUMCNCT05935397
HanYang University Medical Center (HYUMC) Registry
An observational study of Coronary Artery Stenosis and Coronary Artery Disease, run by Hanyang University Seoul Hospital at 3 sites in South Korea.
Trial summary
The HYUMC registry is a two-center, real-world registry of percutaneous coronary intervention in patients with coronary artery disease. From January 2012, PCI-treated patients from Hanyang University Seoul Hospitals and Hanyang University Guri Hospitals were enrolled in this registry. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Stenosis, Coronary Artery Disease, Blood Pressure
- What is being tested?
- percutaneous coronary intervention
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 1 Jan 2012to 31 Dec 2025
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with CAD
Who may be able to join
- Consecutive patients with CAD who underwent PCI one or more drug eluting stent (DES) with from 2012 at the Division of Cardiology of Hanyang University Seoul Hospital and Hanyang University Guri Hospital, Korea.
Who cannot join
- second or subsequent hospitalization records of patients with multiple admissions
- patients who died during index hospitalization
- patients who treated with first-generation drug eluting stent
- patients with an outpatient follow-up record of less than 6 months
- patients with insufficient medical records.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Hanyang University Guri Hospital
Guri-si, 11923
Byung Sik Kim, M.D., fish3777@hanmail.net
- Recruiting
Hanyang University Seoul Hospital
Seoul, 04763
Byung Sik Kim, M.D., fish3777@hanmail.net
- Recruiting
Young-Hyo Lim
Seoul, 04763
Young-Hyo Lim, M.D., PhD, mdoim@hanyang.ac.kr
Byung Sik Kim, M.D, fish3777@hanmail.net
About this study
Official title: HanYang University Medical Center (HYUMC) PCI Registry
The HYUMC registry is a two-center, real-world registry of percutaneous coronary intervention in patients with coronary artery disease. From January 2012, PCI-treated patients from Hanyang University Seoul Hospitals and Hanyang University Guri Hospitals were enrolled in this registry.
The aim of this registry is to examine the long-term clinical outcomes and identify predictors of adverse outcomes following percutaneous coronary intervention conducted at academic hospitals.
Read the detailed description
In the HYUMC registry, the researchers have gathered and assessed various demographic, laboratory, echocardiographic, and angiographic measurements (both on-admission and during follow-up), as well as conducted questionnaires among patients who underwent percutaneous coronary intervention. The primary focus of this registry is to examine the effects of these parameters on long-term clinical outcomes.
- Being tested
- percutaneous coronary intervention
- Medical subject headings
- Coronary Stenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionDevice
patients with CAD undergoing PCI with second generation DES
| Study group | Role | What they receive |
|---|---|---|
| patients with CAD undergoing PCI | patients with CAD undergoing PCI with second generation DES Receives: Device: percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE (major adverse cardiac and cerebrovascular event)
the composite of all-cause death, myocardial infarction, stroke, or any revascularization
Measured: 10-year
Secondary outcomes (4)
All-cause death
death from any cause
Measured: 10-year
Myocardial infarction,
presence of clinical symptoms with the presence of electrocardiographic changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormalities, in conjunction with elevated levels of cardiac biomarker above the 99th percentile upper reference limit
Measured: 10-year
Stroke
neurological deficit resulting from acute focal damage to the central nervous system due to a vascular cause, requiring hospitalization, and confirmed by a neurologist through imaging findings
Measured: 10-year
Any revascularization
PCI or coronary artery bypass surgery on either target or nontarget vessels
Measured: 10-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Jan 2012
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery StenosisStudies 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
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hanyang University
- Responsible party
- Principal investigator, Young-Hyo Lim, Hanyang University Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935397
- Sponsor's protocol ID
- HYUMC
- Acronym
- HYUMC
- Status last verified
- Jun 2023
- First submitted
- 29 Jun 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Publications
Kim BS, Lim YH, Shin J, Shin JH. Association of systolic blood pressure target and variability with long-term clinical outcomes in patients undergoing percutaneous coronary intervention. Clin Hypertens. 2025 Apr 1;31:e13. doi: 10.5646/ch.2025.31.e13. eCollection 2025.
PubMed 40201318Kim BS, Shin JH, Kim W, Kook H, Lee Y, Park JK, Shin J, Lim YH. Association of office blood pressure with ischemic and bleeding events in patients undergoing percutaneous coronary intervention. Sci Rep. 2024 Sep 2;14(1):20310. doi: 10.1038/s41598-024-71060-8.
PubMed 39218965
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HanYang University Medical Center (HYUMC) PCI Registry
- ClinicalTrials.gov ID
- NCT05935397
- Acronym / sponsor ID
- HYUMC / HYUMC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Collaborators
- Hanyang University
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Jul 2023 (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.
The HYUMC registry is a two-center, real-world registry of percutaneous coronary intervention in patients with coronary artery disease. From January 2012, PCI-treated patients from Hanyang University Seoul Hospitals and Hanyang University Guri Hospitals were enrolled in this registry.
The aim of this registry is to examine the long-term clinical outcomes and identify predictors of adverse outcomes following percutaneous coronary intervention conducted at academic hospitals.
Detailed description
In the HYUMC registry, the researchers have gathered and assessed various demographic, laboratory, echocardiographic, and angiographic measurements (both on-admission and during follow-up), as well as conducted questionnaires among patients who underwent percutaneous coronary intervention. The primary focus of this registry is to examine the effects of these parameters on long-term clinical outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with CAD undergoing PCI | – | Device: percutaneous coronary interventionpatients with CAD undergoing PCI with second generation DES |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with CAD
Key inclusion criteria (1 listed)
- Consecutive patients with CAD who underwent PCI one or more drug eluting stent (DES) with from 2012 at the Division of Cardiology of Hanyang University Seoul Hospital and Hanyang University Guri Hospital, Korea.
Key exclusion criteria (5 listed)
- second or subsequent hospitalization records of patients with multiple admissions
- patients who died during index hospitalization
- patients who treated with first-generation drug eluting stent
- patients with an outpatient follow-up record of less than 6 months
- patients with insufficient medical records.
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 interventionpatients with CAD undergoing PCI with second generation DES | Device | patients with CAD undergoing PCI |
Primary outcome
MACCE (major adverse cardiac and cerebrovascular event)
Time frame: 10-year
the composite of all-cause death, myocardial infarction, stroke, or any revascularization
4 secondary outcomes
All-cause death
Time frame: 10-year
Myocardial infarction,
Time frame: 10-year
Stroke
Time frame: 10-year
Any revascularization
Time frame: 10-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Derived from this study: PubMed 40201318Kim BS, Lim YH, Shin J, Shin JH. Association of systolic blood pressure target and variability with long-term clinical outcomes in patients undergoing percutaneous coronary intervention. Clin Hypertens. 2025 Apr 1;31:e13. doi: 10.5646/ch.2025.31.e13. eCollection 2025.
- Derived from this study: PubMed 39218965Kim BS, Shin JH, Kim W, Kook H, Lee Y, Park JK, Shin J, Lim YH. Association of office blood pressure with ischemic and bleeding events in patients undergoing percutaneous coronary intervention. Sci Rep. 2024 Sep 2;14(1):20310. doi: 10.1038/s41598-024-71060-8.
- Individual participant dataSharing planned: Undecided. The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
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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.
3 sites 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 Stenosis and Coronary Artery Disease, run by Hanyang University Seoul Hospital at 3 sites 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 5 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 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE (major adverse cardiac and cerebrovascular event) (time frame: 10-year). 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 NCT05935397, which also lists 2 linked publications.
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 Jul 2023.