UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014055
Receipt No. R000016366
Official scientific title of the study Registry of Severe Aortic Stenosis in Sendai Kousei Hospital
Date of disclosure of the study information 2014/06/01
Last modified on 2014/07/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Registry of Severe Aortic Stenosis in Sendai Kousei Hospital
Title of the study (Brief title) Registry of Severe Aortic Stenosis in Sendai Kousei Hospital
Region
Japan

Condition
Condition Severe aortic stenosis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Observational study, registry of severe aortic stenosis in Sendai Kousei Hospital
Basic objectives2 Others
Basic objectives -Others To enroll all patient of severe aortic stenosis in Sendai Kousei Hospital and to investigate their clinical background, outcome in interventional therapy such as surgery or transcatheter therapy, and outcome in medical therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Survival at 1 year
Key secondary outcomes 30days cardiovascular death in interventional therapy cohort
30days major adverse event in interventional therapy cohort
Major adverse event at 1 year

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Severe aortic stenosis defined as maximal aortic valve velocity greater than 4.0 m/s, systolic mean gradient greater than 40mmHg, or aortic valve area 1.0cm2 in echocardiography
Key exclusion criteria Aortic prosthetic valve
Target sample size 500

Research contact person
Name of lead principal investigator Norio Tada
Organization Sendai Kousei Hospital
Division name Cardiovascular center
Address 4-15 Hirosemachi Aoba Sendai, Miyagi
TEL 022-222-6181
Email noriotada@hotmail.com

Public contact
Name of contact person Norio Tada
Organization Sendai Kousei Hospital
Division name Cardiovascular center
Address 4-15 Hirosemachi Aoba Sendai, Miyagi
TEL 022-222-6181
Homepage URL
Email noriotada@hotmail.com

Sponsor
Institute Sendai Kousei Hospital
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 Sendai Kousei Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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
2014 Year 06 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 05 Month 31 Day
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
2019 Year 05 Month 31 Day
Date of closure to data entry
2020 Year 05 Month 31 Day
Date trial data considered complete
2020 Year 05 Month 31 Day
Date analysis concluded
2021 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information This is an observational study.

Management information
Registered date
2014 Year 05 Month 24 Day
Last modified on
2014 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016366


Contact us.