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 | 2025/04/05 00:47:51 |
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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
Institute of Science Tokyo Hospital
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
Institute of Science Tokyo Hospital
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
Institute of Science Tokyo Hospital
Institute
Department
Personal name
Taishi Yonetsu
Funding Source
Organization
Institute of Science Tokyo Hospital
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
Institute of Science Tokyo 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
東京科学大学病院（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
https://doi.org/10.1016/j.jjcc.2025.01.008
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.jjcc.2025.01.008
Number of participants that the trial has enrolled
2593
Results
A total of 2593 patients were analyzed with a median follow-up of 815 days. No significant difference in TV-MACE-free survival was observed between the ELCA and non-ELCA groups (HR 1.265, 95% CI 0.910-1.757; p=0.161). Stratification by catheter size showed a lower event rate in the large catheter (1.4-1.7 mm) group in univariate analysis, but this was not significant in multivariate analysis. In the propensity-matched cohort (736 patients), TV-MACE-free survival was similar between groups.
Results date posted
| 2025 | Year | 04 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Enrollment was completed.
Under writing the manuscript for the post-hoc analysis.
Date of the first journal publication of results
Baseline Characteristics
Regarding study population of the total cohort, from a total of 2777 patients enrolled in the registry, 184 patients were excluded from the analysis: 3 patients with insufficient angiographic data, 134 patients lost to follow-up within 30 days, 40 patients with multiple culprit lesions treated in the primary PCI, and 7 patients with bypass graft failure. The final dataset comprised 2593 patients including 427 (16.5 %) patients who underwent ELCA and 2166 (84.6 %) patients who did not undergo ELCA.
The ELCA group showed younger age, less frequent hypertension, more frequent prior statin use, higher high-density lipoprotein cholesterol levels, higher triglyceride levels, lower rate of severe calcified lesions, and a greater angiographic reference diameter at baseline. The distribution of Killip classes differed significantly between the two groups, with less prevalent Killip III class in the ELCA group. In terms of angiographic findings, a large thrombus, defined as a TIMI grade 4 or 5 thrombus, was more frequently observed, and the reference diameter was significantly greater in the ELCA group than in the non-ELCA group. The corrected TIMI frame count was worse in the ELCA group than in the non-ELCA group, while no significant differences were observed in the QCA parameters, TIMI flow grade, or myocardial blush grade. In terms of the frequency of procedural complications, there were no significant differences between ELCA and non-ELCA groups in coronary perforation (0 % vs 0.2 %), no-reflow phenomenon (12.6 % vs 13.0 %), coronary dissection (0.5 % vs 0.2 %), or distal embolization (1.2 % vs 0.8 %). The peak creatine kinase myocardial band (CK-MB) level was significantly higher in the ELCA group, whereas the peak cardiac troponin I level was significantly greater in the non-ELCA group.
Participant flow
This study is a retrospectively collected, multicenter registry of patients with STEMI who underwent primary PCI within 24 h from the onset of myocardial infarction. Twelve regional healthcare centers in Japan providing continuous emergency care, including primary PCI for STEMI, participated in this study. ELCA was available at seven of the participating sites.
Consecutive patients with STEMI who underwent primary PCI at the participating sites within 24 h of symptom onset between January 2015 and December 2019 were enrolled. The exclusion criteria were refusal or waiver of agreement to participate, loss of follow-up data at 30 d after primary PCI, and multiple culprit lesions identified at baseline.
Adverse events
None.
Outcome measures
The primary endpoint was target vessel-related major adverse cardiac events (TV-MACE), defined as a composite of cardiovascular death (CVD), target vessel revascularization (TVR), and target vessel non-fatal myocardial infarction (TV-MI). The secondary endpoints were each component of TV-MACE, peak values of cardiac enzymes, angiographical results of primary PCI, including the final TIMI flow grade, and corrected TIMI frame count.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2025 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049999
