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NCT04778969 Clinical Trial

Kor PCI - CAD Patients Treated With PCI: Analysis of the Korean Nationwide Health Insurance Database

Coronary Artery Disease Clinical Trial

Official title:
Coronary Artery Disease Patients Treated With Percutaneous Coronary Intervention: Analysis of the Korean Nationwide Health Insurance Database

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04778969
Other study ID # E-2009-016-1154
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date April 1, 2021

Study information
Verified date February 2021
Source Seoul National University Hospital
Contact Han-Mo Yang, MD, PhD
Phone 8220722677
Email hanname@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Current Status and Prognosis of Coronary artery disease patients treated with coronary intervention - Analysis of the Korean Nationwide Health Insurance Database

Description:

This is a retrospective study and is conducted for all patients who received percutaneous coronary intervention among cohorts registered with the National Health Insurance Service. Primary outcome is all cause of mortality. Secondary outcomes are cardiovascular death, ischemic stroke, cerebral hemorrhage, admission due to gastrointestinal bleeding, and admission due to major bleedings.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200000
Est. completion date April 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All coronary artery disease patients wih Korean NHIS (National Health Insurance Service)-listed PCI Exclusion Criteria: - non-specified

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• drug-eluting stent
A group of percutaneous coronary intervention (PCI) using drug-eluting stents (DES)
• drug-coated balloon
A group of percutaneous coronary intervention (PCI) using drug-coated balloon (DCB)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary All cause of death 'All cause of death' will be recorded as number of participants with 'All cause of death' 10 years
Secondary Cardiovascular death 'Cardiovascular death' will be recorded as number of participants with 'Cardiovascular death' 10 years
Secondary ischemic stroke 'ischemic stroke' will be recorded as number of participants with 'ischemic stroke' 10 years
Secondary Cerebral hemorrhage 'Cerebral hemorrhage' will be recorded as number of participants with 'Cerebral hemorrhage' 10 years
Secondary Admission due to gastrointestinal bleeding 'Admission due to gastrointestinal bleeding' will be recorded as number of participants with 'Admission due to gastrointestinal bleeding' 10 years
Secondary Admission due to major bleeding 'Admission due to major bleeding' will be recorded as number of participants with 'Admission due to major bleeding' Thismeasure is a composite outcome, which includes cerebral hemorrhage, admission due to gastrointestinal bleeding. 10 years
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