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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032353
Receipt No. R000036901
Scientific Title A prospective registry of physical and psychological functional status after surgical or transcatheter aortic valve replacement in patients with aortic valve stenosis.
Date of disclosure of the study information 2018/04/24
Last modified on 2018/10/25

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Basic information
Public title A prospective registry of physical and psychological functional status after surgical or transcatheter aortic valve replacement in patients with aortic valve stenosis.
Acronym Registry of physical and psychological functional status after SAVR or TAVI.
Scientific Title A prospective registry of physical and psychological functional status after surgical or transcatheter aortic valve replacement in patients with aortic valve stenosis.
Scientific Title:Acronym Registry of physical and psychological functional status after SAVR or TAVI.
Region
Japan

Condition
Condition Aortic valve stenosis
Classification by specialty
Cardiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate physical and psychological functional status at before and after SAVR or TAVI, and to find out which pre procedural markers predict these recovery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Ambulation status at a week, 1, 6 and 12 months after procedure. Ambulation status is evaluated with 6-min walk test.
Key secondary outcomes Cumulative survival rate after procedure.
Re-admission after procedure.
Physical function at a week, 1, 6 and 12 months after procedure.
Mini-mental state examination at a week, 1, 6 and 12 months after procedure.
SF-12 at 1, 6 and 12 months after procedure.
NYHA classification at a week, 1, 6 and 12 months after procedure.
Katz index of ADL at a week, 1, 6 and 12 months after procedure.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Age 75 years or older, undergoing TAVI or SAVR with or without concomitant revascularization at Tokushima Red Cross Hospital.
Key exclusion criteria Need for emergency surgery, clinical instability, concomitant replacement or repair of another heart valve or the aorta, difficult to undergoing physical or psychological function test, informed consent was not obtained.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Takase
Organization Tokushima Red Cross Hospital
Division name Department of Rehabilitation
Zip code
Address Irinokuchi 103-banchi, Komatsushima Town, Komatsushima City, Tokushima Pref, 773-8502, Japan.
TEL 0885-32-2555
Email mk_koudai@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Takase
Organization Tokushima Red Cross Hospital
Division name Department of Rehabilitation
Zip code
Address Irinokuchi 103-banchi, Komatsushima Town, Komatsushima City, Tokushima Pref, 773-8502, Japan.
TEL 0885-32-2555
Homepage URL
Email mk_koudai@yahoo.co.jp

Sponsor
Institute Tokushima Red Cross Hospital
Institute
Department

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
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 徳島赤十字病院

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 24 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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a prospective, observational study.

Management information
Registered date
2018 Year 04 Month 24 Day
Last modified on
2018 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036901

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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