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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029508
Receipt No. R000033701
Scientific Title Characteristics of mitral valve leaflet length in patients with pectus excavatum: a singlecenter cross-sectional study
Date of disclosure of the study information 2017/10/17
Last modified on 2018/10/13

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Basic information
Public title Characteristics of mitral valve leaflet length in patients with pectus excavatum: a singlecenter cross-sectional study
Acronym Mitral leaflet length in pectus excavatum
Scientific Title Characteristics of mitral valve leaflet length in patients with pectus excavatum: a singlecenter cross-sectional study
Scientific Title:Acronym Mitral leaflet length in pectus excavatum
Region
Japan

Condition
Condition pectus excavatum
Classification by specialty
Cardiology Chest surgery Adult
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the characteristics of mitral leaflet lengths in pectus excavatum
Basic objectives2 Others
Basic objectives -Others the characteristics of mitral leaflet lengths in pectus excavatum
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes mitral valve leaflet lengths
Key secondary outcomes Ratio of mitral P2 length/A2 length
Haller CT index

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
1 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Pectus excavatum patients who underwent transthoracic echocardiogram between November 2012 and March 2014
Key exclusion criteria Inavailability of accurate measurement of mitral P2 or A2 length
Target sample size 81

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichi Ajiro
Organization National Hospital Organization Yokohama Medical Center
Division name Department of Cardiology
Zip code
Address 3-60-2 Harajuku, Totsuka-ku, Yokohama-shi, Kanagawa, 245-8575, Japan
TEL +81-45-851-2621
Email you617bacchus@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoichi Ajiro
Organization National Hospital Organization Yokohama Medical Center
Division name Department of Cardiology
Zip code
Address 3-60-2 Harajuku, Totsuka-ku, Yokohama-shi, Kanagawa, 245-8575, Japan
TEL +81-45-851-2621
Homepage URL
Email you617bacchus@gmail.com

Sponsor
Institute Department of Cardiology, National Hospital Organization Yokohama Medical Center
Institute
Department

Funding Source
Organization Clinical Research Division of National Hospital Organization Yokohama Medical Center
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 国立病院機構 横浜医療センター

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 17 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 No longer recruiting
Date of protocol fixation
2017 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information (1) the actual P2 and A2 leaflet lengths were compared between normal controls and PE patients older than 16 years; (2) the actual P2 and A2 leaflet lengths were compared between 4 normal controls and 7 age- and sex-matched PE patients 16 years or younger individually (no statistical analysis was conducted due to the small sample number); (3) the A2/P2 ratio, which was calculated to reduce the influence of the growth period, was compared between PE patients older than 16 years and those 16 years or younger; (4) to evaluate the correlation between the extent of chest deformity and the mitral leaflet lengths, the Spearman rank correlation coefficients between the Haller CT index and the actual P2 and A2 mitral leaflet lengths in PE patients older than 16 years and between the Haller CT index and the A2/P2 ratio in all PE patients were calculated.

Management information
Registered date
2017 Year 10 Month 11 Day
Last modified on
2018 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033701

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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