UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058159 |
|---|---|
| Receipt number | R000065896 |
| Scientific Title | Prognostic and Re-evaluative Value of Left Ventricular Hypertrophy in Severe Aortic Stenosis |
| Date of disclosure of the study information | 2025/06/20 |
| Last modified on | 2025/06/12 10:43:58 |
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Basic information
Public title
Prognostic and Re-evaluative Value of Left Ventricular Hypertrophy in Severe Aortic Stenosis
Acronym
Prognostic and Re-evaluative Value of Left Ventricular Hypertrophy in Severe Aortic Stenosis
Scientific Title
Prognostic and Re-evaluative Value of Left Ventricular Hypertrophy in Severe Aortic Stenosis
Scientific Title:Acronym
Prognostic and Re-evaluative Value of Left Ventricular Hypertrophy in Severe Aortic Stenosis
Region
| Japan |
Condition
Condition
Left Ventricular Hypertrophy
Severe Aortic Stenosis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated patients with left ventricular hypertrophy (LVH) identified on preoperative 12-lead electrocardiograms, calculating the odds of severe aortic stenosis based on age and the presence of diabetes mellitus, and compared the results with findings from previous studies. Furthermore, to evaluate the accuracy of ECG-based screening, we cross-referenced the results with echocardiographic findings and determined the frequencies of false negatives and false positives.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association Between Left Ventricular Hypertrophy on Preoperative 12-Lead Electrocardiograms and Severe Aortic Stenosis
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals aged 18 years or older (regardless of sex)
Individuals diagnosed with aortic stenosis prior to undergoing surgery under general anesthesia
Individuals who underwent preoperative transthoracic echocardiography as part of the preoperative evaluation for surgery under general anesthesia
Key exclusion criteria
Individuals with abnormal 12-lead electrocardiogram findings during preoperative evaluation, such as arrhythmias (e.g., atrial fibrillation), right bundle branch block, or left bundle branch block
Individuals with congenital heart disease, such as bicuspid aortic valve
Individuals who expressed their unwillingness to participate in this study
Individuals deemed inappropriate for inclusion in the study by the principal investigator for any other reason
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | MINO |
Organization
Kindai University Hospital
Division name
Department of Nurse anesthetist and Nurse practitioner
Zip code
589-8511
Address
377-2 Onohigashi, Osaka-Sayama City, Osaka Prefecture, Japan
TEL
(072)366-0206
takashi.mino@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | MINO |
Organization
Kindai University Hospital
Division name
Department of Nurse anesthetist and Nurse practitioner
Zip code
589-8511
Address
377-2 Onohigashi, Osaka-Sayama City, Osaka Prefecture, Japan
TEL
(072)366-0206
Homepage URL
takashi.mino@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Kindai University
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
Kindai Hospital Global Research Alliance Center
Address
377-2 Onohigashi, Osaka-Sayama City, Osaka Prefecture, Japan
Tel
(072)366-0206
khgrac.info@med.kindai.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular
Management information
Registered date
| 2025 | Year | 06 | Month | 12 | Day |
Last modified on
| 2025 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065896
