UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023940 |
|---|---|
| Receipt number | R000027567 |
| Scientific Title | Prospective study of evaluating the incidence and clinical outcomes of bioprosthetic aortic-valve thrombosis |
| Date of disclosure of the study information | 2016/09/05 |
| Last modified on | 2018/12/16 21:28:38 |
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Basic information
Public title
Prospective study of evaluating the incidence and clinical outcomes of bioprosthetic aortic-valve thrombosis
Acronym
The incidence and clinical outcomes of bioprosthetic aortic-valve thrombosis
Scientific Title
Prospective study of evaluating the incidence and clinical outcomes of bioprosthetic aortic-valve thrombosis
Scientific Title:Acronym
The incidence and clinical outcomes of bioprosthetic aortic-valve thrombosis
Region
| Japan |
Condition
Condition
Aortic stenosis
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This prospective study was designed to evaluate the incidence, predictors, and clinical outcomes of bioprosthetic aortic-valve thrombosis with multimodality imaging
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of patients with bioprosthetic aortic-valve thrombosis
Key secondary outcomes
Frequency of valve functional abnormalities in patients with bioprosthetic aortic-valve thrombosis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Presence of transcatheter or surgical bioprosthetic aortic valve implanted at least 48 hours prior to enrollment
2) Written informed consent is taken
Key exclusion criteria
1) Reduced renal function (estimated glomerular filtration rate of <30 mL/[min1.73 m2]
2) Known allergy to iodinated contrast agents
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Hayashida |
Organization
Keio University School of Medicine
Division name
Cardiology
Zip code
Address
35 Shinanomachi, Sinjyuku-ku, Tokyo, Japan
TEL
03-3353-1211
k-hayashida@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Yanagisawa |
Organization
Keio University School of Medicine
Division name
Cardiology
Zip code
Address
35 Shinanomachi, Sinjyuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
ryoyanagi0217@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Financial support: none
Organization
Division
Category of Funding Organization
Other
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All included patients undergo four-dimensional contrast-enhanced cardiac computed tomography (CT) and transthoracic echocardiography (TTE) after the procedure to evaluate the incidence of bioprosthetic aortic-valve thrombosis and valve function.
Clinical follow-up is performed at 6 months and 1 year for the first year and annually thereafter along with CT and TTE analysis to clarify the clinical outcomes of thrombosis.
Management information
Registered date
| 2016 | Year | 09 | Month | 05 | Day |
Last modified on
| 2018 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027567
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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