Kitasato PCI Registry

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ClinicalTrials.gov Identifier: NCT05308329

Recruitment Status : Recruiting

First Posted : April 4, 2022

Last Update Posted : April 4, 2022

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View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Yoshiyasu Minami, Kitasato University

Study Description

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.

Study Design

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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

Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease

U.S. FDA Resources

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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 :

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

Eligibility Criteria

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

Contacts and Locations

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

More Information

Publications:

Asakura K, Minami Y, Kinoshita D, Katamine M, Kato A, Katsura A, Sato T, Muramatsu Y, Hashimoto T, Kameda R, Meguro K, Shimohama T, Ako J. Impact of triglyceride levels on plaque characteristics in patients with coronary artery disease. Int J Cardiol. 2022 Feb 1;348:134-139. doi: 10.1016/j.ijcard.2021.12.008. Epub 2021 Dec 9.

Kato A, Minami Y, Asakura K, Katamine M, Katsura A, Muramatsu Y, Sato T, Kakizaki R, Hashimoto T, Meguro K, Shimohama T, Ako J. Characteristics of carotid atherosclerosis in patients with plaque erosion. J Thromb Thrombolysis. 2021 Aug;52(2):620-627. doi: 10.1007/s11239-021-02419-1. Epub 2021 Mar 10.

Hashimoto T, Minami Y, Asakura K, Katamine M, Kato A, Katsura A, Sato T, Muramatsu Y, Kakizaki R, Fujiyoshi K, Ishida K, Kameda R, Meguro K, Shimohama T, Ako J. Achilles tendon thickening is associated with higher incidence of adverse cardiovascular event in patients with coronary artery disease. Heart Vessels. 2021 Feb;36(2):163-169. doi: 10.1007/s00380-020-01679-w. Epub 2020 Aug 6.

Muramatsu Y, Minami Y, Kato A, Katsura A, Sato T, Kakizaki R, Nemoto T, Hashimoto T, Fujiyoshi K, Meguro K, Shimohama T, Ako J. Lipoprotein (a) level is associated with plaque vulnerability in patients with coronary artery disease: An optical coherence tomography study. Int J Cardiol Heart Vasc. 2019 Jun 13;24:100382. doi: 10.1016/j.ijcha.2019.100382. eCollection 2019 Sep.

Kakizaki R, Minami Y, Hashikata T, Nemoto T, Hashimoto T, Fujiyoshi K, Meguro K, Shimohama T, Tojo T, Ako J. Impact of underlying plaque type on strut coverage in the early phase after drug-eluting stent implantation. Coron Artery Dis. 2018 Dec;29(8):624-631. doi: 10.1097/MCA.0000000000000654.

Kakizaki R, Minami Y, Katamine M, Katsura A, Muramatsu Y, Hashimoto T, Meguro K, Shimohama T, Ako J. Clinical outcome of biodegradable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with diabetes. Cardiovasc Diabetol. 2020 Oct 1;19(1):162. doi: 10.1186/s12933-020-01145-x.

Fujiyoshi K, Minami Y, Ishida K, Kato A, Katsura A, Muramatsu Y, Sato T, Kakizaki R, Nemoto T, Hashimoto T, Sato N, Meguro K, Shimohama T, Tojo T, Ako J. Incidence, factors, and clinical significance of cholesterol crystals in coronary plaque: An optical coherence tomography study. Atherosclerosis. 2019 Apr;283:79-84. doi: 10.1016/j.atherosclerosis.2019.02.009. Epub 2019 Feb 14.

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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

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