UMIN-CTR Clinical Trial

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