Kitasato PCI Registry

NCT05308329 | Unknown

• 1 other identifier: KITASATO-B18-099
• Study Type: observational
• Target: 4,500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Major adverse cardiac and cerebrovascular events (MACCE)

  5 years after the PCI

Interventions

Intra-coronary imaging device DEVICE

Culprit/nonculprit lesions are accessed by intra-coronary imaging device including intravascular ultrasound and optical coherence tomography.

PCI procedural characteristics BEHAVIORAL

Procedural characteristics include the information about angiographical characteristics, type of stent, pre/post POBA, and thrombectomy.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with coronary artery disease requiring PCI at Kitasato University Hospital

You may qualify if:

• Patients who underwent PCI

You may not qualify if:

• Patients who did not agree to participate in the registry

Sponsors & Collaborators

• Kitasato University: lead

Study Sites (1)

Kitasato University Hospital

Sagamihara, Kanagawa, 252-0375, Japan

RECRUITING

Related 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.

  PMID: 34896410 BACKGROUND

• 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.

  PMID: 33694096 BACKGROUND

• 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.

  PMID: 32761364 BACKGROUND

• 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.

  PMID: 31245530 BACKGROUND

• 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.

  PMID: 29975201 BACKGROUND

• 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.

  PMID: 33004019 BACKGROUND

• 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.

  PMID: 30802681 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Atherosclerosis; Ischemia; Angina, Stable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Yoshiyasu Minami

  Kitasato University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoshiyasu Minami

CONTACT

nrg12391@yahoo.co.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: April 4, 2022
• Study Start: February 1, 2012
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

JP (1)