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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004812
Receipt No. R000005626
Scientific Title Efficacy of Ischemic Postconditioning Combined with Thrombus Aspiration Therapy in Patients with ST-segment. Elevation Myocardial Infarction.
Date of disclosure of the study information 2011/01/02
Last modified on 2020/05/20

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Basic information
Public title Efficacy of Ischemic Postconditioning Combined with Thrombus Aspiration Therapy in Patients with ST-segment. Elevation Myocardial Infarction.
Acronym iPost study
Scientific Title Efficacy of Ischemic Postconditioning Combined with Thrombus Aspiration Therapy in Patients with ST-segment. Elevation Myocardial Infarction.
Scientific Title:Acronym iPost study
Region
Japan

Condition
Condition Patients with ST-elevation AMI admitted or referred to the Coronary Care Unit of the Division of Cardiology of St.Lukes.International Hospital in Japan, after successful percutaneous coronary intervention and who are eligible for cardiac MRI will be enrolled prospectively. Informed consent
will be obtained from each patient before enrollment in the study, according to the approved protocol.
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary objective is to evaluate whether postconditioning combined thrombus aspiration induced by brief episodes of ischemia-reperfusion
performed during the first minutes of reperfusion obtained by percutaneous coronary intervention, compared to percutaneous coronary intervention without additional intervention.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes ST segment resolution
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 ipost procedure group; n=58
Interventions/Control_2 standard treatment group; n=58
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

Not applicable
Gender Male and Female
Key inclusion criteria Inclusion Criteria
1)Subject must have ST-segment Elevation Myocardial Infarction
2)Subject must be 20 years of age or older.
3)histry of cardiac-ischemia-related symptoms <12 hours prior to initial presentation.
4)clinical decision was made to treat with PCI.
5)Subject must be willing and able to give informed consent.
Key exclusion criteria Exclusion criteria will be previous AMI, candidate of CABG cardiogenic shock or Killip 4, rescue angioplasty after thrombolytic therapy, evidence of coronary collaterals in the risk area, TIMI flow grade 3 before intervention, inability to lay flat due to severe cardiac heart failure/respiratory insufficiency, pregnancy, known existence of a life threatening disease, and inability to give informed consent. In addition, exclusion criteria will be any contraindication to undergo CMR, such as severe renal dysfunction implanted metallic objects;cardiac pacemakers and/or implantable cardioverter defibrillator or any other type of electronic devices, or any other contraindication to CMR. Patients with newly placed intracoronary stents will be included.
Target sample size 116

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuya Watanabe
Organization St.Luke's International Hospital
Division name Cardiology Department
Zip code
Address 9-1,Akashi-cho,Chuou-ku Tokyo,Japan
TEL 03-3541-5151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takuya Watanabe
Organization St.Luke's International Hospital
Division name Cardiology Department
Zip code
Address 9-1,Akashi-cho,Chuou-ku Tokyo,Japan
TEL 03-3541-5151
Homepage URL
Email watataku@luke.or.jp

Sponsor
Institute St.Luke's International Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2011 Year 01 Month 02 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
2010 Year 11 Month 30 Day
Date of IRB
2010 Year 12 Month 01 Day
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2012 Year 06 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
2013 Year 02 Month 01 Day
Date analysis concluded
2013 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 01 Month 02 Day
Last modified on
2020 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005626

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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