Clinical trial NCT04650529: Gyeongsang National University Hospital Registry
Official title: G-NUH (Gyeongsang National University Hospital) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Percutaneous Coronary Intervention
Hemostatic Disorder
Blood Clot
Keywords: East Asian Paradox
Lead sponsor: Gyeongsang National University Hospital
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Medically treated cases

Primary outcomes:
measure: MACE
timeFrame: up to 10 years
Secondary outcomes:
measure: Cardiovascular death
timeFrame: up to 10 years
measure: Myocardial infarction
timeFrame: up to 10 years
measure: Stroke
timeFrame: up to 10 years
measure: Revascularization
timeFrame: up to 10 years
measure: Major bleeding
timeFrame: up to 10 years
measure: Stent thrombosis
timeFrame: up to 10 years
measure: ISR
timeFrame: up to 10 years
Other outcomes:
measure: Incidence of MACE according to platelet function
timeFrame: up to 10 years
measure: Incidence of MACE according to global hemostasis assay
timeFrame: up to 10 years
measure: Incidence of MACE according to hemostatic biomarkers
timeFrame: up to 10 years
measure: Incidence of MACE according to cardiac contractility
timeFrame: up to 10 years
measure: Incidence of MACE according to physiologic index
timeFrame: up to 10 years
measure: Incidence of MACE according to 1-month bleeding & dyspnea episodes
timeFrame: up to 10 years
Locations:
city: Changwon
country: Korea, Republic of
facility: Changwon Gyeongsang National University Hospital
state: Gyeongsangnam-do
city: Jinju
country: Korea, Republic of
facility: Gyeonsang National University Hospital
state: Gyeonsangnam-do
Study officials:
affiliation: Changwon Gyeongsang National University Hospital
name: Young-Hoon Jeong, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.