Gyeongsang National University Hospital Registry

Percutaneous Coronary Intervention Clinical Trial

— GNUH  

Official title:

G-NUH (Gyeongsang National University Hospital) Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04650529
• Other study ID #: G-NUH
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Blood Clot
• Blood Coagulation Disorders
• Hemostatic Disorder
• Hemostatic Disorders
• Percutaneous Coronary Intervention
• Thrombosis

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

External Links

•   Analysis from the G-NUH registry