UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043818 |
|---|---|
| Receipt number | 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 | 2023/04/04 13:44:36 |
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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
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
ymatcvm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
| Delay expected |
Results Delay Reason
Delay of enrollment
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
No longer recruiting
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
| 2023 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049999
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
