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Kitasato PCI Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05308329
Recruitment Status : Recruiting
First Posted : April 4, 2022
Last Update Posted : April 4, 2022
Sponsor:
Information provided by (Responsible Party):
Yoshiyasu Minami, 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.

Condition or disease Intervention/treatment
Acute Coronary Syndrome STEMI - ST-segment Elevation Myocardial Infarction NSTEMI - Non-ST-Segment Elevation Myocardial Infarction Atherosclerosis Coronary; Ischemic Stable Angina Device: Intra-coronary imaging device Behavioral: PCI procedural characteristics

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.

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Study Type : Observational
Estimated Enrollment : 4500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Kitasato Percutaneous Coronary Intervention Registry
Actual Study Start Date : February 1, 2012
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Intra-coronary imaging device
    Culprit/nonculprit lesions are accessed by intra-coronary imaging device including intravascular ultrasound and optical coherence tomography.
  • Behavioral: PCI procedural characteristics
    Procedural characteristics include the information about angiographical characteristics, type of stent, pre/post POBA, and thrombectomy.


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with coronary artery disease requiring PCI at Kitasato University Hospital
Criteria

Inclusion Criteria:

  • Patients who underwent PCI

Exclusion Criteria:

  • Patients who did not agree to participate in the registry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05308329


Contacts
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Contact: Yoshiyasu Minami nrg12391@yahoo.co.jp

Locations
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Japan
Kitasato University Hospital Recruiting
Sagamihara, Kanagawa, Japan, 252-0375
Contact: Yosiyasu Minami, MD, PhD    (81)-42-778-8111    nrg12391@yahoo.co.jp   
Sponsors and Collaborators
Kitasato University
Investigators
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Principal Investigator: Yoshiyasu Minami Kitasato University School of Medicine
Publications:

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Responsible Party: Yoshiyasu Minami, Assistant Professor, Kitasato University
ClinicalTrials.gov Identifier: NCT05308329    
Other Study ID Numbers: KITASATO-B18-099
First Posted: April 4, 2022    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Atherosclerosis
Angina, Stable
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations