UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043818
Receipt No. R000049999
Scientific Title The Registry Study of ST-elevation Myocardial Infarction for the Assessment of the Efficacy of Excimer Laser Coronary Atherectomy (STELA registry)
Date of disclosure of the study information 2021/04/30
Last modified on 2021/04/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The Registry Study of ST-elevation Myocardial Infarction for the Assessment of the Efficacy of Excimer Laser Coronary Atherectomy (STELA registry)
Acronym STELA registry
Scientific Title The Registry Study of ST-elevation Myocardial Infarction for the Assessment of the Efficacy of Excimer Laser Coronary Atherectomy (STELA registry)
Scientific Title:Acronym STELA registry
Region
Japan

Condition
Condition ST-segment elevation myocardial infarction
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this registry is to evaluate the efficacy and safety of excimer laser coronary atherectomy for ST-segment elevation myocardial infarction and to identify the effective group where excimer laser coronary atherectomy is effective.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Composite of major cardiovascular events including cardiovascular death, target vessel revascularization and acute myocardial infarction
Key secondary outcomes Each component of primary outcomes, all-cause death, non-target vessel revascularization (excluding the revascularizations planned at primary administration), lethal arrhythmia

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with ST-segment elevation myocardial infarction who underwent percutaneous coronary intervention between January 1 2015 and December 31 2019 and met the followings criteria were enrolled:
1. The age was twenty years old or more.
2. Percutaneous coronary intervention was performed within twenty four hours after the onset.
Key exclusion criteria 1. Rejection to participate.
2. Unavailable outcome data at 30 days.
3. Investigator's decision.
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Taishi
Middle name
Last name Yonetsu
Organization Tokyo Medical and Dental University Hospital, Faculty of Medicine
Division name Department of Cardiovascular Medicine
Zip code 113-8510
Address Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL 0358035231
Email yntcvm@tmd.ac.jp

Public contact
Name of contact person
1st name Yuji
Middle name
Last name Matsuda
Organization Tokyo Medical and Dental University Hospital, Faculty of Medicine
Division name Department of Cardiovascular Medicine
Zip code 113-8510
Address Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL 0358035231
Homepage URL
Email ymatcvm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Medical and Dental University School of Medicine Ethics Review Board
Address Yushima 1-5-45, Bunkyo-ku, Tokyo
Tel 03-5803-5096
Email syomu1.adm@tmd.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京医科歯科大学医学部附属病院(東京都)、武蔵野赤十字病院(東京都)、都立広尾病院(東京都)、土浦協同病院(東京都)、横須賀共済病院(東京都)、青梅市立総合病院(東京都)、国立病院機構災害医療センター(東京都)、新百合ヶ丘総合病院(東京都)、平塚共済病院(神奈川県)、横浜南共済病院(神奈川県)、横浜市立みなと赤十字病院(神奈川県)、
JAとりで総合医療センター(埼玉県)、亀田総合病院(千葉県)、柏市立柏病院(千葉県)、東京山手メディカルセンター(東京都)、草加市立病院(埼玉県)、秀和総合病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2021 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 2000
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2021 Year 03 Month 13 Day
Date of IRB
2021 Year 03 Month 13 Day
Anticipated trial start date
2021 Year 04 Month 30 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
2024 Year 02 Month 28 Day
Date trial data considered complete
2024 Year 03 Month 31 Day
Date analysis concluded
2026 Year 03 Month 31 Day

Other
Other related information The data about following categories are collected from electric record chart and analyzed.
1. Research subject information
2. General inspection
3. Coronary artery angiography (preoperative, postoperative, post-PCI chronic phase)
4. Catheter treatment
5. Oral medication at discharge
6. Cardiovascular event

Management information
Registered date
2021 Year 04 Month 02 Day
Last modified on
2021 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049999

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.