UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019508 |
|---|---|
| Receipt number | R000022560 |
| Scientific Title | Comparison of Autonomic Nerve Function by Three Procedures including PTAV, TAVR and TAVR in Patients with Severe Aortic Stenosis |
| Date of disclosure of the study information | 2015/10/26 |
| Last modified on | 2015/10/26 21:40:39 |
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Basic information
Public title
Comparison of Autonomic Nerve Function by Three Procedures including PTAV, TAVR and TAVR in Patients with Severe Aortic Stenosis
Acronym
Comparison of improvement on Autonomic Nerve function by 3 interventional treaments for AS patinets
Scientific Title
Comparison of Autonomic Nerve Function by Three Procedures including PTAV, TAVR and TAVR in Patients with Severe Aortic Stenosis
Scientific Title:Acronym
Comparison of improvement on Autonomic Nerve function by 3 interventional treaments for AS patinets
Region
| Japan |
Condition
Condition
Aortic Valvar Stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the pre and post- interventional procudures (SAVR,TAVR,PTAV)in autonomic nervous activity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compared the improvement of autonomic nerve activity by 11C-HED-PET/CT among 3 procedures (SAVR,TAVR,PTAV), pre, after 2 weeks, after 6months,respectively.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
SAVR
Interventions/Control_2
TAVR
Interventions/Control_3
PTAV
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
Symptomatic AS patients who were admitted in our hospital to schedule PTAV, TAVR or SAVR.
AS was diagnosed based on JCS Guideline
Key exclusion criteria
1.Patients with hemodialysis
2.patients with prior history of Myocardial infarction within a month
3. patients with prior history of cerebrovascular events within 6 months
4.patients with LVEF<20%
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mamoru Sakakibara |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine,
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo
TEL
011-706-6973
mike.s@ninus.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mamoru Sakakibara |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo
TEL
011-706-6973
Homepage URL
mike.s@ninus.ocn.ne.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine,Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine,Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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
| 2015 | Year | 10 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 26 | 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
| 2015 | Year | 10 | Month | 26 | Day |
Last modified on
| 2015 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022560
