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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000032954 |
Receipt No. | R000036828 |
Scientific Title | Laser Atherectomy for ST elevation myocardial infarction |
Date of disclosure of the study information | 2018/06/12 |
Last modified on | 2022/06/15 |
Basic information | ||
Public title | Laser Atherectomy for ST elevation myocardial infarction | |
Acronym | LASTPASS | |
Scientific Title | Laser Atherectomy for ST elevation myocardial infarction | |
Scientific Title:Acronym | LASTPASS | |
Region |
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Condition | ||
Condition | ST-elevation acute myocardial infarction (STEMI) | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To clarify the effectiveness of excimer laser coronary angiplasty (ELCA) on myocardial salvage in patients with anterior STEMI evaluated by nuclear scintigraphy (BMIPP 3-9 days after p-PCI and Tc99m-tetrofosmin at 6 months after p-PCI) |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | myocardial salvage = (Risk at area measured by BMIPP 3-9 days after p-PCI) - (Infarct size measured by Tc99m-tetrofosmin at 6 months after p-PCI)
myocardial salvage index (%) = myocardial salvage / Risk at area measured by BMIPP 3-9 days after p-PCI x 100 |
Key secondary outcomes | Myocardial salvage, infarct size, microvascular obstruction by MRI
Left ventricular ejection fraction by TF scintigraphy at 6 months 12 months, 36 months, 60 months Clinical end point Intra-stent tissue volume by OCT |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Cluster |
Blinding | Open -but assessor(s) are blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Excimer laser catheter | |
Interventions/Control_2 | Standard treatment | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients to whom PCI treatment for Anterior STEMI is indicated
[Main selection criteria] First-episode Anterior STEMI patients within 6 hours of onset that satisfy electrocardiogram criteria Patients who are 21 years of age or older at the time of consent acquisition Patient who the patient himself agreed in writing |
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Key exclusion criteria | Patients presenting cardiac shock at the time of visit
Patients whose target lesions are left main trunk, circumflex, right coronary artery, distal anterior descending branch Patients who have TIMI 2, 3 at the initial imaging Patients with a reference vessel diameter of 2.5 mm or less Patients determined to lack consent ability for mental or other reasons Patient who is judged inappropriate by research researcher or research sharing doctor |
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Target sample size | 248 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tokai University | ||||||
Division name | Department of Cardiovascular Medicine | ||||||
Zip code | 259-1193 | ||||||
Address | Kanagawa prefecture Isehara-shi Shimosya store 143 | ||||||
TEL | 0463-93-1121 | ||||||
ikari@is.icc.u-tokai.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Tokai University | ||||||
Division name | Department of Cardiovascular Medicine | ||||||
Zip code | 259-1193 | ||||||
Address | 143 Shimokasuya, Isehara, 259-1193 Japan | ||||||
TEL | 0463-93-1121 | ||||||
Homepage URL | |||||||
f.saito@tokai-u.jp |
Sponsor | |
Institute | Tokai University |
Institute | |
Department |
Funding Source | |
Organization | Tokai 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 | Keio University |
Address | 35 Shinanomachi, Shinjukuku, Tokyo |
Tel | 03-5363-3961 |
crc-admin@ctr.hosp.keio.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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 100 |
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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036828 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |