UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000019508
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email mike.s@ninus.ocn.ne.jp

Sponsor
Institute Department of Cardiovascular Medicine,Hokkaido University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022560

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.