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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021549
Receipt No. R000024774
Scientific Title Exploring MECHANISM of early and late vascular responses of ULTIMASTER sirolimus-eluting stent for treatment of ST-elevation Acute Myocardial Infarction
Date of disclosure of the study information 2016/03/22
Last modified on 2019/03/28

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Basic information
Public title Exploring MECHANISM of early and late vascular responses of ULTIMASTER sirolimus-eluting stent for treatment of ST-elevation Acute Myocardial Infarction
Acronym Evaluation of vascular responses of ULTIMASTER sirolimus-eluting stent for Acute Myocardial Infarction
(MECHANISM-ULTIMASTER-AMI Study)
Scientific Title Exploring MECHANISM of early and late vascular responses of ULTIMASTER sirolimus-eluting stent for treatment of ST-elevation Acute Myocardial Infarction
Scientific Title:Acronym Evaluation of vascular responses of ULTIMASTER sirolimus-eluting stent for Acute Myocardial Infarction
(MECHANISM-ULTIMASTER-AMI Study)
Region
Japan

Condition
Condition Coronary Artery Disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate early, mid-term and late vascular healing after the implantation of Ultimaster Sirolimus-eluting stent in acute myocardial infarction (AMI) patients by Optical Frequency Domain Imaging(OFDI)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The percentage of stent strut coverage by OFDI at 1 month (To observe temporal course from the early stage, the rate of stent-strut coverage in the 3-month arm will also be evaluated in a complementary manner, separately from the 1-month arm.)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Ultimaster Sirolimus-eluting stent,
1month or 3month OFDI
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
85 years-old >
Gender Male and Female
Key inclusion criteria - AMI definition is accordance with the third universal definition of ESC /ACCF/ AHA/ WHF Task Force10, detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn) I or T] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following:

Symptoms of ischemia.
New or presumed new significant STsegment-T wave (ST-T) changes or new left bundlebranch block (LBBB).
Development of pathological Q waves in the ECG.
Imaging evidence of new loss of viable myocardium or new regional wall motionabnormality.
Identification of an intracoronary thrombus by angiography or autopsy

Of the AMI patients who met the above
definition, the criterial for inclusion is limited to STEMI patients. STEMI is defined as new
ST elevation at the J point in at least 2 contiguous leads of equal or greater than 2mm (0.2 mV) in men equal or greater than1.5mm (0.15 mV) in women in leads V2-V3 and/or of equal or greater than 1 mm (0.1mV) in other contiguous chest leads or the limb leads


-Patients having at least one de novo lesion in a coronary artery in whom PCI with a DES is indicated.

-Patients aged 20 to less than 85 years at the time of informed consent

-Patients who have provided written informed consent

-Patients who are able to undergo OFDI examinations of the site of stent placement at 1 month or 3 months and at 12 months
Key exclusion criteria 1) Patients who are judged incapable of undergoing clinical follow-up 12 months after PCI (Consider also the location of patients' residences)
2) Lack of specific findings of ACS by angiography (Left to the operator's decision.)
3) Shock
4) The culprit lesion is the left main coronary trunk
5) Lesion with the reference vessel diameter less than 2.0mm or larger than 4.5mm by visual evaluation.
6) AMI due to stent thrombosis at prior stented segment.
7) Chronic renal failure with serum creatinine level not less than 2.0mg/dl on hospital visit
8) Patients on hemodialysis
9) Cancer patients whose vital prognosis is expected to be within 2 years.
10) Surgery that requires discontinuation of the antiplatelet agent is scheduled within 3 months.
11) Female patient plan to became pregnant or during pregnancy.
12) Patients who experienced adverse
reaction to aspirin or clopidogrel (this shall not apply for patients in whom safety of ticlopidine is confirmed)
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Morino
Organization Iwate Medical University
Division name Division of Cardiology, Department of Internal Medicine
Zip code
Address 19-1 Uchimaru, Morioka, Iwate
TEL 019-651-5111
Email ymorino@iwate-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Morino
Organization The Academic Research Group for Exploring Undiscovered Mechanisms of Cardiovascular Diseases
Division name Department of cardiovascular medicine
Zip code
Address 19-1 Uchimaru, Morioka, Iwate
TEL 019-651-5111
Homepage URL
Email ymorino@iwate-med.ac.jp

Sponsor
Institute Iwate Medical University
Institute
Department

Funding Source
Organization Terumo Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2016 Year 03 Month 22 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 Completed
Date of protocol fixation
2016 Year 02 Month 01 Day
Date of IRB
2016 Year 02 Month 04 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is multicenter prospective single arm registry. Eligible patients are planned to be enrolled between April 2016 and Aug 2017.
PCI related information such as patient's background procedural information. Coronary angiogram and OFDI image data are also collected and analyzed at the independent core laboratory.

Management information
Registered date
2016 Year 03 Month 19 Day
Last modified on
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024774

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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