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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04650529
Other study ID # G-NUH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2010
Est. completion date December 2025

Study information

Verified date January 2021
Source Gyeongsang National University Hospital
Contact Jin Sin Koh, MD, PhD
Phone 82-10-8544-0175
Email kjs0175@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age >= 18 years - Significant coronary artery disease - Treated with PCI - Multiple hemostatic or physiologic measurements Exclusion Criteria: - Medically treated cases

Study Design


Related Conditions & MeSH terms


Intervention

Device:
stent, ballooning
DES, BMS, BRS, DEB, and POBA can be used for PCI

Locations

Country Name City State
Korea, Republic of Changwon Gyeongsang National University Hospital Changwon Gyeongsangnam-do
Korea, Republic of Gyeonsang National University Hospital Jinju Gyeonsangnam-do

Sponsors (1)

Lead Sponsor Collaborator
Gyeongsang National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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 patient — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Incidence of MACE according to platelet function VerifyNow assay up to 10 years
Other Incidence of MACE according to global hemostasis assay thromboelastography (TEG: R, alpha angle, MA and LY30) up to 10 years
Other Incidence of MACE according to hemostatic biomarkers hs-CRP, fibrinogen, D-dimer, NT-proBNP, lipid battery up to 10 years
Other Incidence of MACE according to cardiac contractility Echocardiography: LV EF, E/A, TR Vmax, LAVI up to 10 years
Other Incidence of MACE according to physiologic index fractional flow reserve (FFR), coronary flow reserve (CFR) and the index of microvascular resistance (IMR) up to 10 years
Other Incidence of MACE according to 1-month bleeding & dyspnea episodes Qestionnarres for bleeding, dyspnea, side effects up to 10 years
Primary MACE the composite of cardiovascular death, myocardial infarction or stroke up to 10 years
Secondary Cardiovascular death Mortality related with cardiovascular events up to 10 years
Secondary Myocardial infarction Fatal & non-fatal myocardial infarction up to 10 years
Secondary Stroke Ischemic & hemorrhagic stroke up to 10 years
Secondary Revascularization target-lesion, target-vessel vs. nontarget-vessel up to 10 years
Secondary Major bleeding BARC type 3-5 up to 10 years
Secondary Stent thrombosis Thrombotic events in & near to stent up to 10 years
Secondary ISR in-stent restenosis up to 10 years
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