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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000033403
Receipt No. R000038082
Scientific Title Investigation on the relationship between echocardiographic and clinical data after aortic valve reconstruction using autologous-pericardium surgery
Date of disclosure of the study information 2018/07/20
Last modified on 2019/01/15

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Basic information
Public title Investigation on the relationship between echocardiographic and clinical data after aortic valve reconstruction using autologous-pericardium surgery
Acronym Investigation on the relationship between echocardiographic and clinical data after aortic valve reconstruction using autologous-pericardium surgery
Scientific Title Investigation on the relationship between echocardiographic and clinical data after aortic valve reconstruction using autologous-pericardium surgery
Scientific Title:Acronym Investigation on the relationship between echocardiographic and clinical data after aortic valve reconstruction using autologous-pericardium surgery
Region
Japan

Condition
Condition Aortic valve disease
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will investigate the relationship between echocardiographic findings and clinical background for patients undergoing aortic valve reconstruction using autologous-pericardium surgery.
Basic objectives2 Others
Basic objectives -Others none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Major cardiovascular events
Key secondary outcomes Change in valve morphology after surgery

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients who underwent aortic valve reconstruction using autologous pericardium
Key exclusion criteria Patients who could not perform echocardiography
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masao Moroi
Organization Toho University Medical Center Ohashi Hospital
Division name Department of Cardiology
Zip code
Address 2-22-36 Ohashi, Meguro-ku, Tokyo
TEL 03-3468-1251
Email moroi@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromasa Hayama
Organization Toho University Medical Center Ohashi Hospital
Division name Department of Cardiology
Zip code
Address 2-22-36 Ohashi, Meguro-ku, Tokyo
TEL 03-3468-1251
Homepage URL
Email md16040h@oc.toho-u.ac.jp

Sponsor
Institute Toho University Medical Center Ohashi Hospital
Institute
Department

Funding Source
Organization Toho University Medical Center Ohashi Hospital
Organization
Division
Category of Funding Organization Other
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
2018 Year 07 Month 20 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 Main results already published
Date of protocol fixation
2018 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study
The subjects were patients who underwent aortic valve reconstruction using autologous pericardium from January 2007 to June 2018

Management information
Registered date
2018 Year 07 Month 16 Day
Last modified on
2019 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038082

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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