UMIN-CTR Clinical Trial

Basic information
Public title	A study on the rate of aortic valve stenosis in patients with left ventricular hypertrophy in preoperative electrocardiogram
Acronym	A study on the rate of aortic valve stenosis in patients with left ventricular hypertrophy in preoperative electrocardiogram
Scientific Title	A study on the rate of aortic valve stenosis in patients with left ventricular hypertrophy in preoperative electrocardiogram
Scientific Title:Acronym	A study on the rate of aortic valve stenosis in patients with left ventricular hypertrophy in preoperative electrocardiogram
Region	Japan

Condition
Condition	Aortic valve stenosis
Classification by specialty	Cardiology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Left ventricular hypertrophy (LVH) is a common finding in electrocardiogram. The patients with LVH can have important complication such as aortic valve stenosis. In this study, we investigate the incidence of aortic valve stenosis in the patients with LVH in their electrocardiogram.
Basic objectives2	Others
Basic objectives -Others	Based on the results, we find the indicator for the screening of aortic valve stenosis
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The incidence of aortic valve 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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with LVH in electrocardiogram
Key exclusion criteria	No electrocardiogram was performed
Target sample size	236

Research contact person
Name of lead principal investigator	1st name Shinichi Middle name Last name Nakao
Organization	Kindai University
Division name	Faculty of Medicine, Anesthesiology
Zip code	5898511
Address	377-2 Ono-Higashi,Osaka-Sayama,Osaka
TEL	0723660221
Email	kitaura@med.kindai.ac.jp

Public contact
Name of contact person	1st name Atsuhiro Middle name Last name Kitaura
Organization	Kindai University Faculty of Medicine
Division name	Anesthesiology
Zip code	589-8511
Address	377-2 Ono-Higashi,Osaka-Sayama,Osaka
TEL	0723660221
Homepage URL
Email	kitaura@med.kindai.ac.jp

Sponsor
Institute	Kindai University Faculty of Medicine Department of Anesthesiology
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JP

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kindai University
Address	377-2 Ono-Higashi,Osaka-Sayama,Osaka
Tel	0723660221
Email	anesth@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	近畿大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 01 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	Completed
Date of protocol fixation	2018 Year 07 Month 01 Day
Date of IRB	2018 Year 08 Month 08 Day
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date	2020 Year 12 Month 01 Day
Date of closure to data entry	2020 Year 12 Month 01 Day
Date trial data considered complete	2021 Year 05 Month 15 Day
Date analysis concluded	2021 Year 05 Month 15 Day

Other
Other related information	This study was already finished. The result of this study was published.

Management information
Registered date	2018 Year 11 Month 21 Day
Last modified on	2021 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039869