Percutaneous Coronary InterventionGNUHNCT04650529
Gyeongsang National University Hospital Registry
An observational study of Percutaneous Coronary Intervention and Hemostatic Disorder, run by Gyeongsang National University Hospital at 2 sites in South Korea.
Trial summary
The G-NUH registry is a two-center, real-world registry of percutaneous coronary intervention in patients with significant coronary artery disease. From January 2010, PCI-treated patients from Gyeonsang National University Hospitals (Jinju \& Changwon) were enrolled in this registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention, Hemostatic Disorder, Blood Clot
- What is being tested?
- stent, ballooning
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jan 2010to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The GNUH registry is focused on clinical impact of multiple hemostatic, physiologic and laboratory measurements on CAD patients treated with PCI.
Who may be able to join
- Age >= 18 years
- Significant coronary artery disease
- Treated with PCI
- Multiple hemostatic or physiologic measurements
Who cannot join
- Medically treated cases
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Changwon Gyeongsang National University Hospital
Changwon, Gyeongsangnam-do, 51472
Yongwhi Park, MD PhD, 82-10-2173-7214, angio2000@hanmail.net
- Recruiting
Gyeonsang National University Hospital
Jinju, Gyeonsangnam-do
Jin Sin Koh, MD, PhD, 82-10-8544-0175, kjs0175@gmail.com
About this study
Official title: G-NUH (Gyeongsang National University Hospital) Registry
The G-NUH registry is a two-center, real-world registry of percutaneous coronary intervention in patients with significant coronary artery disease. From January 2010, PCI-treated patients from Gyeonsang National University Hospitals (Jinju \& Changwon) were enrolled in this registry.
The aim of this registry is to investigate long-term clinical outcomes and predictors of adverse outcomes after percutaneous coronary intervention from the academic hospitals.
Read the detailed description
In the G-NUH registry, the investigators have collected and measured multiple hemostatic, physiologic and laboratory measurements (on-admission \& 1-month) and questionnarred from PCI-treated patients. This registry will focus on the impacts of these parameters on long-term clinical outcomes from East Asian patients.
- Being tested
- stent, ballooning
- Keywords
- East Asian Paradox
- Medical subject headings
- Hemostatic Disorders, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stent, ballooningDevice
DES, BMS, BRS, DEB, and POBA can be used for PCI
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
the composite of cardiovascular death, myocardial infarction or stroke
Measured: up to 10 years
Secondary outcomes (7)
Cardiovascular death
Mortality related with cardiovascular events
Measured: up to 10 years
Myocardial infarction
Fatal \& non-fatal myocardial infarction
Measured: up to 10 years
Stroke
Ischemic \& hemorrhagic stroke
Measured: up to 10 years
Revascularization
target-lesion, target-vessel vs. nontarget-vessel
Measured: up to 10 years
Major bleeding
BARC type 3-5
Measured: up to 10 years
Stent thrombosis
Thrombotic events in \& near to stent
Measured: up to 10 years
ISR
in-stent restenosis
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 posted2 Dec 2020
- Study startJan 2010
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies 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
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Gyeongsang National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Hoon Jeong, Gyeongsang National University Hospital
- Investigators
- Young-Hoon Jeong, MD, PhD, Study director, Changwon Gyeongsang National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650529
- Sponsor's protocol ID
- G-NUH
- Acronym
- GNUH
- Status last verified
- Jan 2021
- First submitted
- 23 Nov 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: This registry would be shared with other researchers in terms of whole collected data.
Publications
Bae JS, Ahn JH, Jang JY, Cho SY, Kang MG, Kim KH, Park HW, Koh JS, Park Y, Hwang SJ, Kwak CH, Hwang JY, Tantry US, Gurbel PA, Jeong YH. The Impact of platelet-fibrin clot strength on occurrence and clinical outcomes of peripheral artery disease in patients with significant coronary artery disease. J Thromb Thrombolysis. 2020 Nov;50(4):969-981. doi: 10.1007/s11239-020-02103-w.
PubMed 32279217Kim BS, Ahn JH, Kang MG, Kim KH, Bae JS, Cho YH, Koh JS, Cho EJ, Kim SW, Tantry US, Gurbel PA, Hwang JY, Shin JH, Jeong YH. Arterial stiffness index and blood pressure phenotypes in patients undergoing percutaneous coronary intervention: prognostic implications for ischemic and bleeding events. Clin Hypertens. 2026 Apr 1;32:e15. doi: 10.5646/ch.2026.32.e15. eCollection 2026.
PubMed 41953291Cho JH, Ahn JH, Kang MG, Bae JS, Koh JS, Jung MK, Kim SW, Gorog DA, Tantry US, Gurbel PA, Kim W, Hwang JY, Jeong YH. Residual Cardiovascular Biomarkers After Medical Therapy and Their Prognostic Implications Following Percutaneous Coronary Intervention. JACC Adv. 2026 Feb;5(2):102498. doi: 10.1016/j.jacadv.2025.102498. Epub 2026 Jan 2.
PubMed 41483545Omar M, Kang MG, Jung MK, Ahn JH, Koh JS, Guevarra PI, Kim SW, Tantry US, Gurbel PA, Hwang JY, Jeong YH. Association and Prognostic Implications of "No-Reflow Phenomenon" and Hypercoagulability in Patients With ST-Segment Elevation Myocardial Infarction. JACC Asia. 2025 Nov;5(11):1487-1501. doi: 10.1016/j.jacasi.2025.07.015. Epub 2025 Sep 5.
PubMed 40910963Cho S, Jung M, Ahn JH, Kang MG, Bae JS, Koh JS, Hwang SJ, Kim HS, Kim SW, Hwang JY, Jeong YH. Diabetic Status and Thrombogenicity: Association and Prognostic Implications After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2025 Mar 24;18(6):720-733. doi: 10.1016/j.jcin.2024.12.002.
PubMed 40139850Lee SY, Cho JY, Gorog DA, Angiolillo DJ, Yun KH, Ahn JH, Koh JS, Park Y, Hwang SJ, Hwang JY, Kim JW, Jang Y, Jeong YH. Inflammation and platelet reactivity during adjunctive colchicine versus aspirin in patients with acute coronary syndrome treated with potent P2Y12 inhibitor. Front Med (Lausanne). 2024 Apr 19;11:1349577. doi: 10.3389/fmed.2024.1349577. eCollection 2024.
PubMed 38841588Lee SH, Kim HK, Ahn JH, Kang MG, Kim KH, Bae JS, Cho SY, Koh JS, Park Y, Hwang SJ, Gorog DA, Tantry US, Bliden KP, Gurbel PA, Hwang JY, Jeong YH. Prognostic impact of hypercoagulability and impaired fibrinolysis in acute myocardial infarction. Eur Heart J. 2023 May 14;44(19):1718-1728. doi: 10.1093/eurheartj/ehad088.
PubMed 36857519Ahn JH, Tantry US, Kang MG, Park HW, Koh JS, Bae JS, Cho SY, Kim KH, Jang JY, Park JR, Park Y, Hwang SJ, Kwak CH, Hwang JY, Gurbel PA, Jeong YH. Residual Inflammatory Risk and its Association With Events in East Asian Patients After Coronary Intervention. JACC Asia. 2022 Apr 12;2(3):323-337. doi: 10.1016/j.jacasi.2021.11.014. eCollection 2022 Jun.
PubMed 36338415
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- G-NUH (Gyeongsang National University Hospital) Registry
- ClinicalTrials.gov ID
- NCT04650529
- Acronym / sponsor ID
- GNUH / G-NUH
- Keywords
- East Asian Paradox
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Gyeongsang National University HospitalUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Dec 2020 (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 G-NUH registry is a two-center, real-world registry of percutaneous coronary intervention in patients with significant coronary artery disease. From January 2010, PCI-treated patients from Gyeonsang National University Hospitals (Jinju \& Changwon) were enrolled in this registry.
The aim of this registry is to investigate long-term clinical outcomes and predictors of adverse outcomes after percutaneous coronary intervention from the academic hospitals.
Detailed description
In the G-NUH registry, the investigators have collected and measured multiple hemostatic, physiologic and laboratory measurements (on-admission \& 1-month) and questionnarred from PCI-treated patients. This registry will focus on the impacts of these parameters on long-term clinical outcomes from East Asian patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The GNUH registry is focused on clinical impact of multiple hemostatic, physiologic and laboratory measurements on CAD patients treated with PCI.
Key inclusion criteria (4 listed)
- Age >= 18 years
- Significant coronary artery disease
- Treated with PCI
- Multiple hemostatic or physiologic measurements
Key exclusion criteria (1 listed)
- Medically treated cases
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 |
|---|---|---|
| stent, ballooningDES, BMS, BRS, DEB, and POBA can be used for PCI | Device | – |
Primary outcome
MACE
Time frame: up to 10 years
the composite of cardiovascular death, myocardial infarction or stroke
7 secondary outcomes
Cardiovascular death
Time frame: up to 10 years
Myocardial infarction
Time frame: up to 10 years
Stroke
Time frame: up to 10 years
Revascularization
Time frame: up to 10 years
Major bleeding
Time frame: up to 10 years
Stent thrombosis
Time frame: up to 10 years
ISR
Time frame: up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Results publication: PubMed 32279217Bae JS, Ahn JH, Jang JY, Cho SY, Kang MG, Kim KH, Park HW, Koh JS, Park Y, Hwang SJ, Kwak CH, Hwang JY, Tantry US, Gurbel PA, Jeong YH. The Impact of platelet-fibrin clot strength on occurrence and clinical outcomes of peripheral artery disease in patients with significant coronary artery disease. J Thromb Thrombolysis. 2020 Nov;50(4):969-981. doi: 10.1007/s11239-020-02103-w.
- Derived from this study: PubMed 41953291Kim BS, Ahn JH, Kang MG, Kim KH, Bae JS, Cho YH, Koh JS, Cho EJ, Kim SW, Tantry US, Gurbel PA, Hwang JY, Shin JH, Jeong YH. Arterial stiffness index and blood pressure phenotypes in patients undergoing percutaneous coronary intervention: prognostic implications for ischemic and bleeding events. Clin Hypertens. 2026 Apr 1;32:e15. doi: 10.5646/ch.2026.32.e15. eCollection 2026.
- Derived from this study: PubMed 41483545Cho JH, Ahn JH, Kang MG, Bae JS, Koh JS, Jung MK, Kim SW, Gorog DA, Tantry US, Gurbel PA, Kim W, Hwang JY, Jeong YH. Residual Cardiovascular Biomarkers After Medical Therapy and Their Prognostic Implications Following Percutaneous Coronary Intervention. JACC Adv. 2026 Feb;5(2):102498. doi: 10.1016/j.jacadv.2025.102498. Epub 2026 Jan 2.
- Derived from this study: PubMed 40910963Omar M, Kang MG, Jung MK, Ahn JH, Koh JS, Guevarra PI, Kim SW, Tantry US, Gurbel PA, Hwang JY, Jeong YH. Association and Prognostic Implications of "No-Reflow Phenomenon" and Hypercoagulability in Patients With ST-Segment Elevation Myocardial Infarction. JACC Asia. 2025 Nov;5(11):1487-1501. doi: 10.1016/j.jacasi.2025.07.015. Epub 2025 Sep 5.
- Derived from this study: PubMed 40139850Cho S, Jung M, Ahn JH, Kang MG, Bae JS, Koh JS, Hwang SJ, Kim HS, Kim SW, Hwang JY, Jeong YH. Diabetic Status and Thrombogenicity: Association and Prognostic Implications After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2025 Mar 24;18(6):720-733. doi: 10.1016/j.jcin.2024.12.002.
- Derived from this study: PubMed 38841588Lee SY, Cho JY, Gorog DA, Angiolillo DJ, Yun KH, Ahn JH, Koh JS, Park Y, Hwang SJ, Hwang JY, Kim JW, Jang Y, Jeong YH. Inflammation and platelet reactivity during adjunctive colchicine versus aspirin in patients with acute coronary syndrome treated with potent P2Y12 inhibitor. Front Med (Lausanne). 2024 Apr 19;11:1349577. doi: 10.3389/fmed.2024.1349577. eCollection 2024.
- Derived from this study: PubMed 36857519Lee SH, Kim HK, Ahn JH, Kang MG, Kim KH, Bae JS, Cho SY, Koh JS, Park Y, Hwang SJ, Gorog DA, Tantry US, Bliden KP, Gurbel PA, Hwang JY, Jeong YH. Prognostic impact of hypercoagulability and impaired fibrinolysis in acute myocardial infarction. Eur Heart J. 2023 May 14;44(19):1718-1728. doi: 10.1093/eurheartj/ehad088.
- Derived from this study: PubMed 36338415Ahn JH, Tantry US, Kang MG, Park HW, Koh JS, Bae JS, Cho SY, Kim KH, Jang JY, Park JR, Park Y, Hwang SJ, Kwak CH, Hwang JY, Gurbel PA, Jeong YH. Residual Inflammatory Risk and its Association With Events in East Asian Patients After Coronary Intervention. JACC Asia. 2022 Apr 12;2(3):323-337. doi: 10.1016/j.jacasi.2021.11.014. eCollection 2022 Jun.
- Analysis from the G-NUH registryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. This registry would be shared with other researchers in terms of whole collected data.
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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.
Young-Hoon Jeong, MD, PhD study director
Changwon Gyeongsang National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Coronary Intervention and Hemostatic Disorder, run by Gyeongsang National University Hospital at 2 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 4 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 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Contact Jin Sin Koh, MD, PhD (82-10-8544-0175, kjs0175@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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?
On the ClinicalTrials.gov record for NCT04650529, which also lists 8 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 27 Jan 2021.