UMIN-CTR Clinical Trial

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
Last 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
1st 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