UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000036669
Receipt No. R000041784
Scientific Title The impact of the degree of myocardial injury after transcatheter aortic valve implantation on left ventricle function after TAVI and predictors of myocardial injury after transcatheter aortic valve implantation
Date of disclosure of the study information 2019/12/31
Last modified on 2019/05/07 (Ver. 1)

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Basic information
Public title The impact of the degree of myocardial injury after transcatheter aortic valve implantation on left ventricle function after TAVI and predictors of myocardial injury after transcatheter aortic valve implantation: SAPIEN 3 study

Acronym The impact of the degree of myocardial injury after transcatheter aortic valve implantation on left ventricle function after TAVI and predictors of myocardial injury after transcatheter aortic valve implantation
Scientific Title The impact of the degree of myocardial injury after transcatheter aortic valve implantation on left ventricle function after TAVI and predictors of myocardial injury after transcatheter aortic valve implantation
Scientific Title:Acronym The impact of the degree of myocardial injury after transcatheter aortic valve implantation on left ventricle function after TAVI and predictors of myocardial injury after transcatheter aortic valve implantation
Region
Japan

Condition
Condition aortic valve stenosis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To aim to the impact of the degree of myocardial injury after transcatheter aortic valve implantation on left ventricle function after TAVI and predictors of myocardial injury after transcatheter aortic valve implantation
Basic objectives2 Others
Basic objectives -Others To aim to the impact of the degree of myocardial injury after transcatheter aortic valve implantation on left ventricle function after TAVI and predictors of myocardial injury after transcatheter aortic valve implantation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The elevation in troponin T and recovery of cardiac function
Key secondary outcomes

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
70 years-old <=
Age-upper limit
95 years-old >
Gender Male and Female
Key inclusion criteria 1) the presence of symptoms, 2) degenerative aortic stenosis with a New York Heart Association class II or higher, 3) an aortic-valve area < 1.0 cm2 (or an effective orifice area index < 0.6 cm2/m2) or mean pressure gradient >40 mmHg, 4) transfemoral (TF) approach, and 5) successful procedure
Key exclusion criteria the use of dialysis
Target sample size 68

Research contact person
Last name of lead principal investigator
1st name Takao
Middle name
Last name Sato
Organization Tachikawa general hospital
Division name Cardiology
Zip code 940-8621
Address 1-24 asahioka, Nagaoka city, Niigata prefecture Japan
TEL 0258-33-3111
Email kirotaro19731013@yahoo.co.jp

Public contact
1st name of contact person
1st name Takao
Middle name
Last name Sato
Organization Tachikawa general hospital
Division name Cardiology
Zip code 940-8621
Address 1-24 asahioka, Nagaoka city, Niigata prefecture Japan
TEL 0258-33-3111
Homepage URL
Email kirotaro19731013@yahoo.co.jp

Sponsor
Institute Tachikawa general hospital
Institute
Department

Funding Source
Organization nothing to declare
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 Tachikawa general hospital
Address 1-24 asahioka, Nagaoka city, Niigata prefecture Japan
Tel 0258-33-3111
Email kirotaro19731013@yahoo.co.jp

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
2019 Year 12 Month 31 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 68
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 Completed
Date of protocol fixation
2018 Year 08 Month 08 Day
Date of IRB
2018 Year 08 Month 31 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

Management information
Registered date
2019 Year 05 Month 07 Day
Last modified on
2019 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041784