UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020528 |
|---|---|
| Receipt number | R000023700 |
| Scientific Title | Evaluation of effect of remote ischemic peri-conditioning on the activation of sympathetic nervous system in patients with acute myocardial infarction |
| Date of disclosure of the study information | 2016/01/12 |
| Last modified on | 2016/01/12 10:12:33 |
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Basic information
Public title
Evaluation of effect of remote ischemic peri-conditioning on the activation of sympathetic nervous system in patients with acute myocardial infarction
Acronym
Evaluation of effect of RIPC on the activation of sympathetic nervous system in patients with acute myocardial infarction
Scientific Title
Evaluation of effect of remote ischemic peri-conditioning on the activation of sympathetic nervous system in patients with acute myocardial infarction
Scientific Title:Acronym
Evaluation of effect of RIPC on the activation of sympathetic nervous system in patients with acute myocardial infarction
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of remote ischemic peri-conditioning on the sympathetic nerve activation in patients with acute myocardial infarction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Late H/M ratio and washout rate of MIBG scintigraphy (planar image) at discharge
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
reperfusion therapy + remote ischemic peri-conditioning
Interventions/Control_2
reperfusion therapy
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
1 Patients with ST elevation myocardial infarction undergoing reperfusion therapy
2 Patients who received sufficient explanation, understood it and gave written consent based on their free will, before participating in this study
Key exclusion criteria
1 Patients with non-ST-elevation acute coronary syndrome
2 Patients who need percutaneous cardiopulmonary support
3 Patients who have difficulties to undergo the therapy, mentally or physically
4 Patients who are judged inappropriate by the principal investigator
Target sample size
162
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takumi Kondo |
Organization
Osaka General Medical Center
Division name
Department of Cardiology
Zip code
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
kenkyusien@gh.opho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takumi Kondo |
Organization
Osaka General Medical Center
Division name
Department of Cardiology
Zip code
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
Homepage URL
kenkyusien@gh.opho.jp
Sponsor or person
Institute
Osaka General Medical Center
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
| 2016 | Year | 01 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 12 | Day |
Last modified on
| 2016 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023700
