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RecruitingNCT04650529GNUHUpdated Jan 27, 2021

Gyeongsang National University Hospital Registry

An observational study in Percutaneous Coronary Intervention, Hemostatic Disorder and Blood Clot, sponsored by Gyeongsang National University Hospital. Recruiting at 2 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-27.

Sponsored by Gyeongsang National University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2010; still recruiting 16 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Percutaneous Coronary Intervention
  • Hemostatic Disorder
  • Blood Clot

Keywords

  • East Asian Paradox
03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 213 across 586 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Gyeongsang National University Hospital is the lead sponsor of 21 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Medically treated cases
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Interventions

  • Devicestent, ballooning

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

06

What researchers measure

Primary outcomes

  1. MACE

    the composite of cardiovascular death, myocardial infarction or stroke

    Time frame: up to 10 years

Secondary outcomes

  1. Cardiovascular death

    Mortality related with cardiovascular events

    Time frame: up to 10 years

  2. Myocardial infarction

    Fatal \& non-fatal myocardial infarction

    Time frame: up to 10 years

  3. Stroke

    Ischemic \& hemorrhagic stroke

    Time frame: up to 10 years

  4. Revascularization

    target-lesion, target-vessel vs. nontarget-vessel

    Time frame: up to 10 years

  5. Major bleeding

    BARC type 3-5

    Time frame: up to 10 years

  6. Stent thrombosis

    Thrombotic events in \& near to stent

    Time frame: up to 10 years

  7. ISR

    in-stent restenosis

    Time frame: up to 10 years

Other outcomes

  1. Incidence of MACE according to platelet function

    VerifyNow assay

    Time frame: up to 10 years

  2. Incidence of MACE according to global hemostasis assay

    thromboelastography (TEG: R, alpha angle, MA and LY30)

    Time frame: up to 10 years

  3. Incidence of MACE according to hemostatic biomarkers

    hs-CRP, fibrinogen, D-dimer, NT-proBNP, lipid battery

    Time frame: up to 10 years

  4. Incidence of MACE according to cardiac contractility

    Echocardiography: LV EF, E/A, TR Vmax, LAVI

    Time frame: up to 10 years

  5. Incidence of MACE according to physiologic index

    fractional flow reserve (FFR), coronary flow reserve (CFR) and the index of microvascular resistance (IMR)

    Time frame: up to 10 years

  6. Incidence of MACE according to 1-month bleeding & dyspnea episodes

    Qestionnarres for bleeding, dyspnea, side effects

    Time frame: up to 10 years

07

Study locations

2 of 2 sites recruiting
  • Changwon Gyeongsang National University Hospital
    Changwon, Gyeongsangnam-do 51472, Korea, Republic of
    Recruiting
  • Gyeonsang National University Hospital
    Jinju, Gyeonsangnam-do, Korea, Republic of
    Recruiting
08

References and documents

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 32279217 ↗
  • 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. PubMed 36338415 ↗

Individual participant data

Plan to share: Undecided — This registry would be shared with other researchers in terms of whole collected data.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04650529
Lead sponsor
Gyeongsang National University Hospital
Responsible party
Young-Hoon Jeong (Director, Cardiovascular Center, Gyeongsang National University Hospital) — Principal investigator
First posted
Dec 2, 2020
Start date
Jan 2010
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jan 27, 2021

Study contacts

Jin Sin Koh, MD, PhD
Contact
kjs0175@gmail.com
82-10-8544-0175
Young-Hoon Jeong, MD, PhD
study director · Changwon Gyeongsang National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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