UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japanese Aortic Stenosis Study
Title of the study (Brief title)	JASS
Region	Japan

Condition
Condition	aortic valve stenosis or calcification
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify 1) factors related to the progression of aortic valve stenosis or calcification 2) the natural course of aortic valve stenosis or calcification 3) effective therapeutic approaches
Basic objectives2	Others
Basic objectives -Others	This is an observational study
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Severity of aortic stenosis or calcification assessed by echocardiography 2) Clinical events or symptoms for 3 years
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	transaortic valve velocity > or = 2m/s or leaflet calcification of aortic valve
Key exclusion criteria	1, rheumatic valve changes 2, post-operation of aortic valve 3, scheduled aortic valve operation 4, not suitable to this study (a doctor decides)
Target sample size	300

Research contact person
Name of lead principal investigator	kazuhiro Yamamoto
Organization	Tottori University, Faculty of Medicine
Division name	The Department of Molecular Medicine and Therapeutics
Address	86 Nishi-cho, Yonago, 683-8503, Japan
TEL	0859-38-6517
Email	ykazuhiro@med.tottori-u.ac.jp

Public contact
Name of contact person	kazuhiro Yamamoto
Organization	Tottori University, Faculty of Medicine
Division name	The Department of Molecular Medicine and Therapeutics
Address	86 Nishi-cho, Yonago, 683-8503, Japan
TEL	0859-38-6517
Homepage URL
Email	ykazuhiro@med.tottori-u.ac.jp

Sponsor
Institute	Tottori University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	the Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

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	2007 Year 05 Month 07 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2007 Year 03 Month 16 Day
Anticipated trial start date	2007 Year 06 Month 01 Day
Last follow-up date	2013 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	The results of the retrospective analysis were published in Hypertens Res 2010 ;33:269-74. The results of the prospective analysis were published in Circ J 2015;79:2050-7
Other related information	This study consists of JASS (retrospective and prospective studies).

Management information
Registered date	2007 Year 05 Month 05 Day
Last modified on	2016 Year 05 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000000842