UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005932 |
|---|---|
| Receipt number | R000007013 |
| Scientific Title | Post Ischemic Conditioning for Heart Failure study |
| Date of disclosure of the study information | 2011/07/06 |
| Last modified on | 2011/07/05 20:56:29 |
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Basic information
Public title
Post Ischemic Conditioning for Heart Failure study
Acronym
PICTURE study
Scientific Title
Post Ischemic Conditioning for Heart Failure study
Scientific Title:Acronym
PICTURE study
Region
| Japan |
Condition
Condition
Acute and chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of post ischemic conditioning in patients with heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of cardiac function
Key secondary outcomes
Change of inflammatory cytokines and collagens
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Four cycles of alternating 5-min inflation and 5-min deflation of upper-arm blood-pressure cuff to 200 mm Hg, twice a day, for seven days
Interventions/Control_2
Standard heart failure 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who admitted in the hospital with heart failure
2) Patients with do not need drip infusion therapy
3) Patients who can endure intermittent arms compression
Key exclusion criteria
1) Patients with systolic blood pressure > 200mmHg
2) Patients with CABG operation recently
3) Patients who have received dialysis
4) Patients considered not eligible for the study by the attending doctor due to other reasons
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Yoshiyama |
Organization
Osaka city university graduate school of medicine
Division name
Department of cardiology
Zip code
Address
1-4-3, Asahimachi Abeno-ku, Osaka
TEL
06-6645-3801
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihisa Hanatani |
Organization
Osaka city university graduate school of medicine
Division name
Department of cardiology
Zip code
Address
1-4-3, Asahimachi Abeno-ku, Osaka
TEL
06-6645-3801
Homepage URL
hanatania@msic.med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of cardiology
Osaka city university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Department of cardiology
Osaka city university graduate school of medicine
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 | 07 | Month | 06 | 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
| 2011 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 05 | Day |
Last modified on
| 2011 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007013
