UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043828 |
|---|---|
| Receipt number | R000049541 |
| Scientific Title | Exploratory research for identifying blood biomarkers associated with aortic valve and arterial calcification in patients following transcatheter aortic valve implantation |
| Date of disclosure of the study information | 2021/04/05 |
| Last modified on | 2022/04/03 13:10:34 |
* 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
Public title
Exploratory research for identifying blood biomarkers associated with aortic valve and arterial calcification in patients following transcatheter aortic valve implantation
Acronym
Exploratory research for identifying blood biomarkers associated with aortic valve and arterial calcification in patients following transcatheter aortic valve implantation
Scientific Title
Exploratory research for identifying blood biomarkers associated with aortic valve and arterial calcification in patients following transcatheter aortic valve implantation
Scientific Title:Acronym
Exploratory research for identifying blood biomarkers associated with aortic valve and arterial calcification in patients following transcatheter aortic valve implantation
Region
| Japan |
Condition
Condition
Aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To identify blood biomarkers associated with aortic and arterial calcification in patients following transcatheter aortic valve implantation
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
all-cause death
Key secondary outcomes
heart failure hospitalization
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who underwent transcatheter aortic valve implantation
Key exclusion criteria
patient refusal
heart transplant recipients
Target sample size
650
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Iwata |
Organization
Juntendo University
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
hiroiwata-circ@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Chikata |
Organization
Juntendo University
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
ychikata@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
none
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
Juntendo University
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-3111
kenkyu5858@juntendo.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
| 2021 | Year | 04 | 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
300
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
single center observational study
Management information
Registered date
| 2021 | Year | 04 | Month | 02 | Day |
Last modified on
| 2022 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049541
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
