UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021549
Receipt number 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 13:52:32

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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 or person

Institute

Iwate Medical University

Institute

Department

Personal name



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

Value
https://center6.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