Gangwon PCI Prospective Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorYonsei University

About this trial

This prospective, multicenter registry will consecutively enroll patients of all ages undergoing percutaneous coronary intervention (PCI) at four university hospitals in Gangwon Province, Republic of Korea.

The study will describe contemporary clinical, procedural, and medication treatment patterns and assess 1-year clinical outcomes in routine practice.

The primary outcome is patient-oriented composite outcome (POCO), defined as all-cause death, any myocardial infarction, or any repeat revascularization.

No study-specific intervention will be assigned.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients of any age undergoing percutaneous coronary intervention (PCI) at a participating hospital during the study period.

Written informed consent is obtained from the patient or a legally authorized representative before collection of study data, unless the requirement for informed consent is waived by the Institutional Review Board.

Disqualifiers

Refusal or withdrawal of informed consent, when informed consent is required.

No PCI performed during the index hospital encounter.

Trial population

The study population will consist of consecutive, all-comer patients of any age undergoing percutaneous coronary intervention (PCI) at four participating university hospitals in Gangwon Province, Republic of Korea. Patients undergoing PCI for any clinical presentation, including chronic coronary syndrome and acute coronary syndrome, will be eligible. There will be no restrictions based on sex, clinical presentation, comorbidity, lesion complexity, or procedural characteristics. Patients undergoing staged PCI during the same hospitalization will be included. Information on the initial and subsequent procedures will be recorded separately using dedicated electronic case report forms.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Percutaneous Coronary Intervention (PCI)

    Procedure/Surgery

    PCI performed as part of routine clinical care; no study-specific procedure is assigned.

Treatment groups

10,000 Participants
are divided into 1 treatment group
Group A: Patients undergoing PCI1 intervention

Trial outcomes

Primary outcomes

1

Patient-oriented composite outcome (POCO)

A composite of all-cause death, any myocardial infarction, or any repeat revascularization.

Time frame
Within 1 year after the index PCI procedure

Secondary outcomes

1

Device-oriented composite outcome (DOCO)

A composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization.

Time frame
Within 1 year after the index PCI procedure
2

All-cause death

Death from any cause

Time frame
Within 1 year after the index PCI procedure
3

Cardiovascular death

Death resulting from a cardiovascular cause.

Time frame
Within 1 year after the index PCI procedure
4

Any myocardial infarction

Any myocardial infarction occurring after the index PCI procedure.

Time frame
Within 1 year after the index PCI procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yonsei University

Lead sponsor

Gangwon Cardiovascular Health Research Institute

Collaborator