UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004812 |
|---|---|
| Receipt number | 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 09:30:34 |
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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
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
watataku@luke.or.jp
Sponsor or person
Institute
St.Luke's International Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005626
