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

Email

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


Email

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

Email

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