UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053343 |
|---|---|
| Receipt number | R000060871 |
| Scientific Title | European Association of Cardiovascular Imaging Multiple and Mixed Valvular Diseases Study |
| Date of disclosure of the study information | 2024/01/16 |
| Last modified on | 2024/01/13 18:09:29 |
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Basic information
Public title
European Association of Cardiovascular Imaging Multiple and Mixed Valvular Diseases Study
Acronym
EACVI-MMVD study
Scientific Title
European Association of Cardiovascular Imaging Multiple and Mixed Valvular Diseases Study
Scientific Title:Acronym
EACVI-MMVD study
Region
| Japan | Europe |
Condition
Condition
Multiple and mixed valvular diseases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is a prospective multicentre observational study conducted as a cohort study with a 1-year follow-up. Consecutive patients with a diagnosis of MMVD who meet the inclusion criteria will be included during the 6 months period of recruitment. Primary outcomes are to assess the proportion of MMVD and prognostic outcomes in MMVD.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the proportion of MMVD
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age more than 18 years
2. Diagnosis of MMVD confirmed by transthoracic echocardiography, defined as:
3. Patient not refusing to have their data involved in the protocol after information.
Key exclusion criteria
1. History of prior valve surgery or percutaneous valve intervention concerning a valve other than those involved in the definition of MMVD.
2. Acute infective endocarditis at the time of evaluation for inclusion (confirmed according to modified Duke criteria) or history of endocarditis less than 6 months.
3. Complex congenital heart diseases.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Kinugawa |
Organization
Faculty of Medicine, Academic Assembly, University of Toyama
Division name
The Second Department of Internal Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama, Toyama, Japan
TEL
076-434-7297
kinugawa@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Toshihide |
| Middle name | |
| Last name | Izumida |
Organization
Faculty of Medicine, Academic Assembly, University of Toyama
Division name
The Second Department of Internal Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama, Toyama, Japan
TEL
076-434-7297
Homepage URL
toshiizu@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
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
Ethics Committee, University of Toyama
Address
2630 Sugitani, Toyama, Toyama, Japan
Tel
076-434-7681
rinri@adm.u-toyama.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
| 2024 | Year | 01 | Month | 16 | 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
| 2023 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
European Association of Cardiovascular Imaging Multiple and Mixed Valvular Diseases Study
Management information
Registered date
| 2024 | Year | 01 | Month | 13 | Day |
Last modified on
| 2024 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060871
