UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029447 |
|---|---|
| Receipt number | R000033644 |
| Scientific Title | Evaluation of left ventricular Fibrosis and Ischemia in severe aortic stenosis beFore and After aortic valve replacement. FIFA -study |
| Date of disclosure of the study information | 2017/10/05 |
| Last modified on | 2017/10/05 21:41:53 |
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Basic information
Public title
Evaluation of left ventricular Fibrosis and Ischemia in severe aortic stenosis beFore and After aortic valve replacement.
FIFA -study
Acronym
FIFA study
Scientific Title
Evaluation of left ventricular Fibrosis and Ischemia in severe aortic stenosis beFore and After aortic valve replacement.
FIFA -study
Scientific Title:Acronym
FIFA study
Region
| Europe |
Condition
Condition
Observational, prospective study
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the left ventricle in severe aortic stenosis before and after aortic valve replacement by means of cardiac computed tomography and magnetic resonance imaging.
Basic objectives2
Others
Basic objectives -Others
Evaluation left ventricular ischemia and fibrosis in aortic stenosis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate coronary vessels before and after aortic valve replacement and left ventricular fibrosis. 1 year follow-up.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with severe aortic stenosis planned for aortic valve replacement.
Key exclusion criteria
- Refusal to give informed consent
- History of cardiac intervention (CABG, PCI, valve surgery)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Vincent Michiels MD |
Organization
Brussels University Hospital
Division name
Cardiology
Zip code
Address
Laarbeeklaan 101 1090 Brussels
TEL
0032474550904
vincent.michiels@uzbrussel.be
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Vincent Michiels MD |
Organization
Brussels University hospital
Division name
Cardiology
Zip code
Address
Laarbeeklaan 101
TEL
0032474550904
Homepage URL
vincent.michiels@uzbrussel.be
Sponsor or person
Institute
Brussels University hospital
Cardiology
Institute
Department
Personal name
Funding Source
Organization
Brussels University Hospital
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2017 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient follow-up will be done at the outpatient clinical visits.
Management information
Registered date
| 2017 | Year | 10 | Month | 05 | Day |
Last modified on
| 2017 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033644
