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Name:
UMIN ID:

Recruitment status Enrolling by invitation
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 2019/01/21

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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
Japan

Condition
Condition ST-elevation acute myocardial infarction (STEMI)
Classification by specialty
Cardiology
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
Device,equipment
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
21 years-old <=
Age-upper limit

Not applicable
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
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
Target sample size 248

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Ikari Yuji
Organization Tokai University
Division name Department of Cardiovascular Medicine
Zip code
Address Kanagawa prefecture Isehara-shi Shimosya store 143
TEL 0463-93-1121
Email ikari@is.icc.u-tokai.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Fumie Saito
Organization Tokai University
Division name Department of Cardiovascular Medicine
Zip code
Address 143 Shimokasuya, Isehara, 259-1193 Japan
TEL 0463-93-1121
Homepage URL
Email natsumedaoverture1928@hotmail.com

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
Address
Tel
Email

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
2018 Year 06 Month 12 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
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
2018 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 12 Day
Last modified on
2019 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.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


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