UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029508 |
|---|---|
| Receipt number | 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 | 2023/03/18 10:56:28 |
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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 | Yoichi |
| Middle name | |
| Last name | Ajiro |
Organization
National Hospital Organization Yokohama Medical Center
Division name
Department of Cardiology
Zip code
245-8575
Address
3-60-2 Harajuku, Totsuka-ku, Yokohama-shi, Kanagawa, 245-8575, Japan
TEL
+81-45-851-2621
you617bacchus@gmail.com
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Ajiro |
Organization
National Hospital Organization Yokohama Medical Center
Division name
Department of Cardiology
Zip code
245-8575
Address
3-60-2 Harajuku, Totsuka-ku, Yokohama-shi, Kanagawa, 245-8575, Japan
TEL
+81-45-851-2621
Homepage URL
you617bacchus@gmail.com
Sponsor or person
Institute
Department of Cardiology, National Hospital Organization Yokohama Medical Center
Institute
Department
Personal name
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
National Hospital Organization Yokohama Medical Center
Address
3-60-2 Harajuku, Totsuka-ku, Yokohama-shi, Kanagawa, 245-8575, Japan
Tel
+81-45-851-2621
chikenk@hosp.go.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
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
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0212165#sec013
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0212165
Number of participants that the trial has enrolled
81
Results
The characteristic features of the shorter posterior mitral leaflet, the longer anterior mitral leaflet, the shorter coaptation depth, and the longer papillary muscle tethering length in patients with PE was demonstrated. This finding might provide a clue regarding the etiology of mitral valve prolapse in PE at its possible earliest form.
Results date posted
| 2020 | Year | 04 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 02 | Month | 11 | Day |
Baseline Characteristics
TThirty-five consecutive patients who were diagnosed with PE and who underwent transthoracic echocardiography between November 2012 and March 2014 were registered. Moreover, 46 healthy individuals with no history of heart failure, atrial fibrillation, myocardial infarction, cardiomyopathy, pericardial disease, or valvular heart disease from the same period were registered as normal controls.
Participant flow
Participants were enrolled with obtaining informed consent by opt-out method
Adverse events
no adverse events
Outcome measures
The P2 and A2 lengths were separately compared between 2 groups: older than 16 years and 16 years or younger. Furthermore, the correlations between actual P2 or A2 lengths and Haller computed tomography index, an index of chest deformity, were investigated in patients with PE exclusively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033701
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