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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04778969
• Collaborator: (none)
• Enrollment: 200,000

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Drug-eluting Stents; Drug-coated Balloon	Device: drug-eluting stent; Device: drug-coated balloon

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Coronary Artery Disease Patients Treated With Percutaneous Coronary Intervention: Analysis of the Korean Nationwide Health Insurance Database
• Anticipated Study Start Date: Apr 1, 2021
• Anticipated Primary Completion Date: Apr 1, 2021
• Anticipated Study Completion Date: Apr 1, 2021

Outcome Measures

Primary Outcome Measures

1. All cause of death [10 years]

   'All cause of death' will be recorded as number of participants with 'All cause of death'

Secondary Outcome Measures

1. Cardiovascular death [10 years]

   'Cardiovascular death' will be recorded as number of participants with 'Cardiovascular death'

2. ischemic stroke [10 years]

   'ischemic stroke' will be recorded as number of participants with 'ischemic stroke'

3. Cerebral hemorrhage [10 years]

   'Cerebral hemorrhage' will be recorded as number of participants with 'Cerebral hemorrhage'

4. Admission due to gastrointestinal bleeding [10 years]

   'Admission due to gastrointestinal bleeding' will be recorded as number of participants with 'Admission due to gastrointestinal bleeding'

5. Admission due to major bleeding [10 years]

   '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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All coronary artery disease patients wih Korean NHIS (National Health Insurance Service)-listed PCI

Exclusion Criteria:

• non-specified

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Han-Mo Yang, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04778969
• Other Study ID Numbers: E-2009-016-1154
• First Posted: Mar 3, 2021
• Last Update Posted: Mar 3, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Study Results

No Results Posted as of Mar 3, 2021