NCT04650529

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10.9 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

15.9 years

First QC Date

November 23, 2020

Last Update Submit

January 26, 2021

Conditions

Percutaneous Coronary InterventionHemostatic DisorderBlood Clot

Keywords

East Asian Paradox

Outcome Measures

Primary Outcomes (1)

  • MACE

    the composite of cardiovascular death, myocardial infarction or stroke

    up to 10 years

Secondary Outcomes (7)

  • Cardiovascular death

    up to 10 years

  • Myocardial infarction

    up to 10 years

  • Stroke

    up to 10 years

  • Revascularization

    up to 10 years

  • Major bleeding

    up to 10 years

  • +2 more secondary outcomes

Other Outcomes (6)

  • Incidence of MACE according to platelet function

    up to 10 years

  • Incidence of MACE according to global hemostasis assay

    up to 10 years

  • Incidence of MACE according to hemostatic biomarkers

    up to 10 years

  • +3 more other outcomes

Interventions

stent, ballooningDEVICE

DES, BMS, BRS, DEB, and POBA can be used for PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The GNUH registry is focused on clinical impact of multiple hemostatic, physiologic and laboratory measurements on CAD patients treated with PCI.

You may qualify if:

  • Age \>= 18 years
  • Significant coronary artery disease
  • Treated with PCI
  • Multiple hemostatic or physiologic measurements

You may not qualify if:

  • Medically treated cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Changwon Gyeongsang National University Hospital

Changwon, Gyeongsangnam-do, 51472, South Korea

RECRUITING

Gyeonsang National University Hospital

Jinju, Gyeonsangnam-do, South Korea

RECRUITING

Related Publications (7)

  • 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.

    PMID: 32279217RESULT

  • Cho 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 Jan 2;5(2):102498. doi: 10.1016/j.jacadv.2025.102498. Online ahead of print.

    PMID: 41483545DERIVED

  • Omar 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.

    PMID: 40910963DERIVED

  • Cho 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.

    PMID: 40139850DERIVED

  • Lee 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.

    PMID: 38841588DERIVED

  • Lee 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.

    PMID: 36857519DERIVED

  • Ahn 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.

    PMID: 36338415DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

After we receive patients' approval, their blood would be collected before PCI. The blood will be stored in Biobank (Gyeongsang National University Hospital).

MeSH Terms

Conditions

Hemostatic DisordersThrombosis

Interventions

Stents

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Young-Hoon Jeong, MD, PhD

    Changwon Gyeongsang National University Hospital

    STUDY DIRECTOR

Central Study Contacts

Jin Sin Koh, MD, PhD

CONTACT

82-10-8544-0175kjs0175@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Cardiovascular Center

Study Record Dates

First Submitted

November 23, 2020

First Posted

December 2, 2020

Study Start

January 1, 2010

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 27, 2021

Record last verified: 2021-01

Locations

KR(2)