Kitasato PCI Registry

Recruiting

• Conditions: NSTEMI - Non-ST-Segment Elevation Myocardial Infarction; Acute Coronary Syndrome; Atherosclerosis; Coronary; Ischemic; Stable Angina; STEMI - ST-segment Elevation Myocardial Infarction

• Registration Number: NCT05308329
• Lead Sponsor: Kitasato University

Brief Summary

The Kitasato PCI Registry is a single-center, observational, prospective study. This study aims to investigate the impact of characteristics in clinical manifestation, patients' background, procedure of percutaneous coronary intervention (PCI), and pre/post PCI culprit/nonculprit lesion observed by intra-coronary imaging modality on clinical outcomes.

Detailed Description

Subjects who underwent PCI are eligible in this registry. The analysis for clinical characteristics, PCI procedural characteristics and findings of intra-coronary imaging including optical coherence tomography (OCT) and intravascular ultrasound (IVUS) is conducted. Subjects are clinically followed up to 5 years after the PCI.

Study Timeline

• Study Start: 2012-02-01
• Study First Submitted: 2022-01-11
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-29
• Last Update Submitted: 2022-03-29
• Study First Posted: 2022-04-04
• Last Update Posted: 2022-04-04
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4500

Inclusion Criteria

• Patients who underwent PCI

Exclusion Criteria

• Patients who did not agree to participate in the registry

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device-oriented clinical end points (DoCE)	5 years after the PCI	Composite of all-cause death, myocardial infarction, ischemic stroke, clinically indicated Composite of cardiac death, target lesion revascularization and stent thrombosis

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiac and cerebrovascular events (MACCE)	5 years after the PCI	Composite of all-cause death, myocardial infarction, ischemic stroke, clinically indicated coronary revascularization

Trial Locations

Locations (1)

Kitasato University Hospital; 🇯🇵 Sagamihara, Kanagawa, Japan