NCT04778969

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

Same day

First QC Date

January 13, 2021

Last Update Submit

February 28, 2021

Conditions

Coronary Artery DiseaseDrug-eluting StentsDrug-coated Balloon

Outcome Measures

Primary Outcomes (1)

  • All cause of death

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

    10 years

Secondary Outcomes (5)

  • Cardiovascular death

    10 years

  • ischemic stroke

    10 years

  • Cerebral hemorrhage

    10 years

  • Admission due to gastrointestinal bleeding

    10 years

  • Admission due to major bleeding

    10 years

Interventions

drug-eluting stentDEVICE

A group of percutaneous coronary intervention (PCI) using drug-eluting stents (DES)

Also known as: DES group
drug-coated balloonDEVICE

A group of percutaneous coronary intervention (PCI) using drug-coated balloon (DCB)

Also known as: DCB group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All coronary artery disease patients wih Korean NHIS (National Health Insurance Service)-listed PCI Patients are selected based on the registered treatment insurance code.

You may qualify if:

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

You may not qualify if:

  • non-specified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Central Study Contacts

Han-Mo Yang, MD, PhD

CONTACT

8220722677hanname@gmail.com

Hak Seung Lee, MD

CONTACT

821031668399cardiolee@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2021

First Posted

March 3, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

March 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Since this research is conducted with a national public institution, data cannot be shared.