UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033403 |
|---|---|
| Receipt number | 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 18:43:31 |
* 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
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
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
md16040h@oc.toho-u.ac.jp
Sponsor or person
Institute
Toho University Medical Center Ohashi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038082
