Acute Coronary SyndromeNCT05308329
Kitasato PCI Registry
An observational study of Acute Coronary Syndrome and STEMI - ST-segment Elevation Myocardial Infarction, run by Kitasato University at 1 site in Japan.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome, STEMI - ST-segment Elevation Myocardial Infarction, NSTEMI - Non-ST-Segment Elevation Myocardial Infarction
- What is being tested?
- Intra-coronary imaging device and PCI procedural characteristics
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 4,500 participants
- Where
- 1 siteJapan
- Study dates
- 1 Feb 2012to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with coronary artery disease requiring PCI at Kitasato University Hospital
Who may be able to join
- Patients who underwent PCI
Who cannot join
- Patients who did not agree to participate in the registry
Trial locations and contacts
1 site in 1 country.
Yoshiyasu Minami contact
Japan1 site, 1 recruiting
- Recruiting
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0375
Yosiyasu Minami, MD, PhD, (81)-42-778-8111, nrg12391@yahoo.co.jp
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Coronary Syndrome, STEMI - ST-segment Elevation Myocardial Infarction, NSTEMI - Non-ST-Segment Elevation Myocardial Infarction, Atherosclerosis, Coronary; Ischemic, Stable Angina
- Being tested
- Intra-coronary imaging device, PCI procedural characteristics
- Medical subject headings
- Acute Coronary Syndrome, Atherosclerosis, Ischemia, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-coronary imaging deviceDevice
Culprit/nonculprit lesions are accessed by intra-coronary imaging device including intravascular ultrasound and optical coherence tomography.
PCI procedural characteristicsBehavioural
Procedural characteristics include the information about angiographical characteristics, type of stent, pre/post POBA, and thrombectomy.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years after the PCI
Secondary outcomes (1)
Major adverse cardiac and cerebrovascular events (MACCE)
Composite of all-cause death, myocardial infarction, ischemic stroke, clinically indicated coronary revascularization
Measured: 5 years after the PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Feb 2012
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kitasato University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshiyasu Minami, Kitasato University
- Investigators
- Yoshiyasu Minami, Principal investigator, Kitasato University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308329
- Sponsor's protocol ID
- KITASATO-B18-099
- Status last verified
- Mar 2022
- First submitted
- 11 Jan 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34896410Kato 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.
PubMed 33694096Hashimoto 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.
PubMed 32761364Muramatsu 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.
PubMed 31245530Kakizaki 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.
PubMed 29975201Kakizaki 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.
PubMed 33004019Fujiyoshi 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.
PubMed 30802681
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kitasato Percutaneous Coronary Intervention Registry
- ClinicalTrials.gov ID
- NCT05308329
- Acronym / sponsor ID
- KITASATO-B18-099
- Conditions
- Acute Coronary Syndrome, STEMI - ST-segment Elevation Myocardial Infarction, NSTEMI - Non-ST-Segment Elevation Myocardial Infarction, Atherosclerosis, Coronary; Ischemic, Stable Angina
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Kitasato UniversityUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with coronary artery disease requiring PCI at Kitasato University Hospital
Key inclusion criteria (1 listed)
- Patients who underwent PCI
Key exclusion criteria (1 listed)
- Patients who did not agree to participate in the registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-coronary imaging deviceCulprit/nonculprit lesions are accessed by intra-coronary imaging device including intravascular ultrasound and optical coherence tomography. | Device | – |
| PCI procedural characteristicsProcedural characteristics include the information about angiographical characteristics, type of stent, pre/post POBA, and thrombectomy. | Behavioural | – |
Primary outcome
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
1 secondary outcome
Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 5 years after the PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Background: PubMed 34896410Asakura 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.
- Background: PubMed 33694096Kato 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.
- Background: PubMed 32761364Hashimoto 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.
- Background: PubMed 31245530Muramatsu 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.
- Background: PubMed 29975201Kakizaki 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.
- Background: PubMed 33004019Kakizaki 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.
- Background: PubMed 30802681Fujiyoshi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshiyasu Minami contact
Yoshiyasu Minami principal investigator
Kitasato University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and STEMI - ST-segment Elevation Myocardial Infarction, run by Kitasato University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoshiyasu Minami (nrg12391@yahoo.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device-oriented clinical end points (DoCE) (time frame: 5 years after the PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05308329, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.