![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000014055 |
Receipt No. | R000016366 |
Scientific Title | 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 |
Basic information | ||
Public title | Registry of Severe Aortic Stenosis in Sendai Kousei Hospital | |
Acronym | Registry of Severe Aortic Stenosis in Sendai Kousei Hospital | |
Scientific Title | Registry of Severe Aortic Stenosis in Sendai Kousei Hospital | |
Scientific Title:Acronym | Registry of Severe Aortic Stenosis in Sendai Kousei Hospital | |
Region |
|
Condition | ||
Condition | Severe aortic stenosis | |
Classification by specialty |
|
|
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 |
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
Organization | Sendai Kousei Hospital | ||||||
Division name | Cardiovascular center | ||||||
Zip code | |||||||
Address | 4-15 Hirosemachi Aoba Sendai, Miyagi | ||||||
TEL | 022-222-6181 | ||||||
noriotada@hotmail.com |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Sendai Kousei Hospital | ||||||
Division name | Cardiovascular center | ||||||
Zip code | |||||||
Address | 4-15 Hirosemachi Aoba Sendai, Miyagi | ||||||
TEL | 022-222-6181 | ||||||
Homepage URL | |||||||
noriotada@hotmail.com |
Sponsor | |
Institute | Sendai Kousei Hospital |
Institute | |
Department |
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) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry |
|
||||||
Date trial data considered complete |
|
||||||
Date analysis concluded |
|
Other | |
Other related information | This is an observational study. |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016366 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |