UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025357 |
|---|---|
| Receipt number | R000029190 |
| Scientific Title | Risk stratification for sudden cardiac death in patients with mitral valve prolapse, based on cardiac imaging |
| Date of disclosure of the study information | 2020/07/31 |
| Last modified on | 2018/01/02 17:37:47 |
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Basic information
Public title
Risk stratification for sudden cardiac death in patients with mitral valve prolapse, based on cardiac imaging
Acronym
Risk stratification for sudden cardiac death in mitral valve prolapse
Scientific Title
Risk stratification for sudden cardiac death in patients with mitral valve prolapse, based on cardiac imaging
Scientific Title:Acronym
Risk stratification for sudden cardiac death in mitral valve prolapse
Region
| Europe |
Condition
Condition
Mitral valve prolapse
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sudden cardiac death is an important health issue, still affection 1 on 1000 persons per year. Mitral valve prolapse has since long been associated with sudden cardiac death in young people. The pathophysiological link between the presence of mitral valve prolapse and the occurrence of sudden cardiac death is not yet fully understood. Furthermore, guidelines for the assessment of the arrhythmic risk in patients with mitral valve prolapse are lacking.
In this study, the arrhythmic profile of patients with mitral valve prolapse will be assessed based on repeated Holter monitoring recordings. Transthoracic echocardiography and cardiac magnetic resonance will be performed in order to detect subtle structural and mechanical changes. Blood samples will be collected to look for potential biomarkers. Electrophysiological data and respectively imaging features and biological data will be correlated. In this way, new predictors for the risk of severe ventricular arrhythmias in patients with mitral valve prolapse can be identified. This will also allow to further elucidate the pathophysiological link between mitral valve prolapse and the occurence of severe arrhythmias.
Basic objectives2
Others
Basic objectives -Others
Diagnostic
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
(Aborted) sudden cardiac death or severe ventricular arrhythmias. After 2 years.
Key secondary outcomes
Premature ventricular complexes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Baseline cardiac magnetic resonance and echocardiography. ECG and Holter monitoring every 6 months.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Diagnosis of mitral valve prolapse or Barlow's disease on echocardiography
Ability to give informed consent
Key exclusion criteria
Severe valvular disease or heart disease from a different origine
Severe renal failure
Life expectancy of less than one year
Inability to give informed consent
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Esther Scheirlynck |
Organization
Universitair ziekenhuis Brussel
Division name
Cardiology department
Zip code
Address
Laarbeeklaan 101, 1090 Jette
TEL
00324776009
escheirl@vub.ac.be
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Esther Scheirlynck |
Organization
Universitair ziekenhuis Brussel
Division name
Cardiology department
Zip code
Address
Laarbeeklaan 101, 1090 Jette
TEL
00324776009
Homepage URL
escheirl@vub.ac.be
Sponsor or person
Institute
Cardiology department UZ Brussel, under supervision of Bernard Cosyns
Institute
Department
Personal name
Funding Source
Organization
Cardiology department UZ Brussel, under supervision of Bernard Cosyns
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
University hospital (Brussels)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 31 | 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
| 2016 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 02 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 21 | Day |
Last modified on
| 2018 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029190
| 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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