UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052402 |
|---|---|
| Receipt number | R000059821 |
| Scientific Title | Prognostic Value of Right Ventricular Free Wall Longitudinal Strain in Aortic Stenosis: A Systematic Review and Meta-analysis |
| Date of disclosure of the study information | 2023/10/04 |
| Last modified on | 2024/04/04 10:49:00 |
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Basic information
Public title
Prognostic Value of Right Ventricular Free Wall Longitudinal Strain in Aortic Stenosis: A Systematic Review and Meta-analysis
Acronym
Prognostic Value of Right Ventricular Free Wall Longitudinal Strain in Aortic Stenosis: A Systematic Review and Meta-analysis
Scientific Title
Prognostic Value of Right Ventricular Free Wall Longitudinal Strain in Aortic Stenosis: A Systematic Review and Meta-analysis
Scientific Title:Acronym
Prognostic Value of Right Ventricular Free Wall Longitudinal Strain in Aortic Stenosis: A Systematic Review and Meta-analysis
Region
| Japan |
Condition
Condition
Aortic stenosis
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A systematic review and meta-analysis of prognostic value of right ventricular free wall strain in aortic stenosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary end point is the hazard ratio of right ventricular free wall longitudinal strain in patients with aortic stenosis.
Key secondary outcomes
The secondary end point is to compare the prognostic value of right ventricular free wall longitudinal strain with other right chamber parameters.
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) The studies are cohort studies.
(2) The studies are of patients with aortic stenosis in whom right ventricular free wall longitudinal strain with echocardiography is measured.
(3) We collect other right chamber parameters such as pulmonary arterial pressure, fractional area change, tricuspid annular systolic excursion.
(4) The studies describe hazard ratio and its 95% confidence interval of outcomes.
Key exclusion criteria
We use aortic stenosis, right ventricular free wall longitudinal strain, prognosis, and outcome as key words for search.
In addition, followings are exclusion criterion.
(1) Systematic review or meta-analysis articles.
(2) Case reports.
(3) Articles that only provide hazard ratio as a dichotomous variable.
(4) Studies not provided standard deviation of each parameter.
(5) Studies published in languages other than English.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Takeuchi |
Organization
Hospital of University of Occupational and Environmental Health
Division name
Department of Laboratory and Transfusion Medicine
Zip code
807-8556
Address
1-1 Iseigaoka, Yahatanishi, Kitakyushu, 807-8555 Japan
TEL
093-603-1611
takeuchi@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Takeuchi |
Organization
Hospital of University of Occupational and Environmental Health
Division name
Department of Laboratory and Transfusion Medicine
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishi, Kitakyushu, 807-855 Japan
TEL
093-603-1611
Homepage URL
takeuchi@med.uoeh-u.ac.jp
Sponsor or person
Institute
Hospital of University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hospital of University of Occupational and Environmental Health
Address
1-1 Iseigaoka, Yahatanishi, Kitakyushu 807-8555 japan
Tel
093-603-1611
rinrisys@mbox.pub.uoeh-u.ac.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
福岡県
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
doi: 10.1016/j.jjcc.2023.11.008
Number of participants that the trial has enrolled
2547
Results
Nine studies with 10 discrete study population were included in this metaanalysis (2547 patients). The total event number was 679. The pooled HR for 1SD reduction in RVfwLS was 1.56 (95% CI, 1.39 to 1.75). RVfwLS failed to show any superiority over traditional parameters (SPAP, FAC, and TAPSE).
Results date posted
| 2024 | Year | 04 | Month | 04 | Day |
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
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Articles were searched in PubMed and Scopus. The search was performed through June 5th, 2023.
Management information
Registered date
| 2023 | Year | 10 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059821
