UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of ascending aortic expansion rate in patients with bicuspid aortic valve (surgical intervention) and bicuspid valve without surgical intervention
Acronym	Postoperative review of bicuspid valve patients
Scientific Title	Postoperative review of bicuspid valve patients
Scientific Title:Acronym	Postoperative review of bicuspid valve patients
Region	Japan

Condition
Condition	Bicuspid aortic valve
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The guidelines state that the indication for surgery of the ascending aorta in patients with the bicuspid aortic valve is 45 mm or more, but we will examine whether 45 mm is really the cutoff line. In addition, we examined how unoperated bicuspid valves that have undergone ascending aortic replacement produce changes.
Basic objectives2	Others
Basic objectives -Others	Bicuspid valve patients are prone to ascending aortic enlargement, and the ascending aorta is operated on at the same time. However, the 45mm guideline is based on clinical data from overseas and is not based on Japanese original data. In the present study, we used 10 years of follow-up data of bicuspid valve patients after aortic valve replacement to determine the appropriate diameter of ascending aortic replacement in bicuspid valve patients.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Assessing aortic diameter more than 10 years after surgery Ascending aortic diameter on CT Valsalva, AVd, STJ, Pressure gradient of aortic valve on echo testing
Key secondary outcomes	Ascending aortic diameter at the time of reoperation

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	Bicuspid aortic valve
Key exclusion criteria	Patients who underwent ascending aortic replacement at the same time as aortic valve replacement
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Ken Middle name Last name Nakamura
Organization	Saitama Cardiovascular and Respiratory Center
Division name	Cardiac Surgery
Zip code	360-0197
Address	1696, Itai, Kumagaya-shi, Saitama
TEL	+81485369920
Email	cardiacsurgken@ybb.ne.jp

Public contact
Name of contact person	1st name KEN Middle name Last name NAKAMURA
Organization	Saitama Cardiovascular and Respiratory Center
Division name	Cardiac Surgery
Zip code	360-0197
Address	1696, Itai, Kumagaya-shi, Saitama
TEL	+81485369920
Homepage URL
Email	cardiacsurgken@ybb.ne.jp

Sponsor
Institute	Saitama Cardiovascular and Respiratory Center
Institute
Department

Funding Source
Organization	Saitama Cardiovascular and Respiratory Center
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saitama Cardiovascular and Respiratory Center Cardiac Surgery
Address	1696, Itai, Kumagaya-shi, Saitama
Tel	+81485369920
Email	cardiacsurgken@ybb.ne.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	2020 Year 06 Month 21 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	2000 Year 01 Month 01 Day
Date of IRB	2020 Year 07 Month 10 Day
Anticipated trial start date	2000 Year 01 Month 01 Day
Last follow-up date	2025 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Follow up with an annual echocardiogram CT scan.

Management information
Registered date	2020 Year 06 Month 21 Day
Last modified on	2021 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046632