Gyeongsang National University Hospital Registry (GNUH)

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.

Study Overview

• Status: Recruiting
• Conditions: Percutaneous Coronary Intervention; Hemostatic Disorder; Blood Clot
• Intervention / Treatment: Device: stent, ballooning

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 Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Jin Sin Koh, MD, PhD; Phone Number: 82-10-8544-0175; Email: kjs0175@gmail.com

Study Locations

• Korea, Republic of
  • Gyeongsangnam-do
    • Changwon, Gyeongsangnam-do, Korea, Republic of, 51472
      • Recruiting
      • Changwon Gyeongsang National University Hospital
      • Contact: Yongwhi Park, MD PhD; Phone Number: 82-10-2173-7214; Email: angio2000@hanmail.net
  • Gyeonsangnam-do
    • Jinju, Gyeonsangnam-do, Korea, Republic of
      • Recruiting
      • Gyeonsang National University Hospital
      • Contact: Jin Sin Koh, MD, PhD; Phone Number: 82-10-8544-0175; Email: kjs0175@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Medically treated cases

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	the composite of cardiovascular death, myocardial infarction or stroke	up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular death	Mortality related with cardiovascular events	up to 10 years
Myocardial infarction	Fatal & non-fatal myocardial infarction	up to 10 years
Stroke	Ischemic & hemorrhagic stroke	up to 10 years
Revascularization	target-lesion, target-vessel vs. nontarget-vessel	up to 10 years
Major bleeding	BARC type 3-5	up to 10 years
Stent thrombosis	Thrombotic events in & near to stent	up to 10 years
ISR	in-stent restenosis	up to 10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of MACE according to platelet function	VerifyNow assay	up to 10 years
Incidence of MACE according to global hemostasis assay	thromboelastography (TEG: R, alpha angle, MA and LY30)	up to 10 years
Incidence of MACE according to hemostatic biomarkers	hs-CRP, fibrinogen, D-dimer, NT-proBNP, lipid battery	up to 10 years
Incidence of MACE according to cardiac contractility	Echocardiography: LV EF, E/A, TR Vmax, LAVI	up to 10 years
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
Incidence of MACE according to 1-month bleeding & dyspnea episodes	Qestionnarres for bleeding, dyspnea, side effects	up to 10 years

Collaborators and Investigators

• Sponsor: Gyeongsang National University Hospital
• Investigators: Study Director: Young-Hoon Jeong, MD, PhD, Changwon Gyeongsang National University Hospital

Publications and helpful links

General 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.
• 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.

Helpful Links

• Analysis from the G-NUH registry

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: East Asian Paradox
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Embolism and Thrombosis; Hemostatic Disorders; Blood Coagulation Disorders; Thrombosis
• Other Study ID Numbers: G-NUH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This registry would be shared with other researchers in terms of whole collected data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes