Kitasato PCI Registry

March 29, 2022 updated by: Yoshiyasu Minami, Kitasato University

Kitasato Percutaneous Coronary Intervention Registry

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

4500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Kanagawa
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Recruiting
        • Kitasato University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with coronary artery disease requiring PCI at Kitasato University Hospital

Description

Inclusion Criteria:

  • Patients who underwent PCI

Exclusion Criteria:

  • Patients who did not agree to participate in the registry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device-oriented clinical end points (DoCE)
Time Frame: 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
5 years after the PCI

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kitasato University

Investigators

  • Principal Investigator: Yoshiyasu Minami, Kitasato University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Anticipated)

March 31, 2025

Study Completion (Anticipated)

March 31, 2025

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KITASATO-B18-099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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