Kitasato PCI Registry

Acute Coronary Syndrome Clinical Trial

Official title:

Kitasato Percutaneous Coronary Intervention Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05308329
• Other study ID #: KITASATO-B18-099
• Status: Recruiting
• Start date: February 1, 2012
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2022
• Source: Kitasato University
• Contact: Yoshiyasu Minami
• Email: nrg12391[@]yahoo.co.jp
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4500
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who underwent PCI

Exclusion Criteria:

• Patients who did not agree to participate in the registry

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Stable
• Atherosclerosis
• Coronary; Ischemic
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• Stable Angina

Intervention

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.

Locations

Country	Name	City	State
Japan	Kitasato University Hospital	Sagamihara	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Kitasato University

Country where clinical trial is conducted

Japan, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device-oriented clinical end points (DoCE)	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	Major adverse cardiac and cerebrovascular events (MACCE)	Composite of all-cause death, myocardial infarction, ischemic stroke, clinically indicated coronary revascularization	5 years after the PCI