UMIN-CTR Clinical Trial

Basic information
Public title	Impairment of Peripheral Endothelial Function in Patients with Aortic Valve Stenosis in the Aging Population
Acronym	Endothelial dysfunction in aortic valve stenosis
Scientific Title	Impairment of Peripheral Endothelial Function in Patients with Aortic Valve Stenosis in the Aging Population
Scientific Title:Acronym	Endothelial dysfunction in aortic valve stenosis
Region	Japan

Condition
Condition	aortic valve stenosis
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the correlation between aortic valve stenosis and peripheral endothelial function.
Basic objectives2	Others
Basic objectives -Others	Assessment of pathophysiology.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The correlation between aortic valve stenosis and peripheral endothelial function.
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	65 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with aortic valve stenosis.
Key exclusion criteria	We excluded patients with acute coronary syndrome who required emergency coronary areteriography, defined as either acute myocardial infarction, those with unstable angina (class II or III of Braunwald's classification). We also excluded patients with advanced collagen disease, endocrine disease, active inflammatory disease, severe liver dysfunction and neoplasm, and those on hemodialysis.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Tsujita
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
Zip code	860-8556
Address	1-1-1 Honjo, Chuo-ku, Kumamoto City, Japan
TEL	81-96-373-5175
Email	ogawah@kumamoto-u.ac.jp

Public contact
Name of contact person	1st name Koichiro Middle name Last name Fujisue
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
Zip code	860-8556
Address	1-1-1 Honjo, Chuo-ku, Kumamoto City, Japan
TEL	81-96-373-5175
Homepage URL
Email	fujisues@kumamoto-u.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Institute
Department

Funding Source
Organization	the Ministry of Education, Science, and Culture in Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Human Ethics Review Committee of Kumamoto University
Address	1-1-1 Honjo, Chuo-ku, Kumamoto City, Japan
Tel	81-96-373-5657
Email	byi-senshin@jimu.kumamoto-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

Other administrative information
Date of disclosure of the study information	2013 Year 08 Month 05 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	Open public recruiting
Date of protocol fixation	2006 Year 06 Month 01 Day
Date of IRB	2006 Year 06 Month 01 Day
Anticipated trial start date	2006 Year 07 Month 01 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We will assess the biochemical profiles, parameters of echocardiogram, and peripheral endothelial function using RH-PAT in patients with aortic valve stenosis.

Management information
Registered date	2013 Year 08 Month 05 Day
Last modified on	2022 Year 08 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013330