UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053482 |
|---|---|
| Receipt number | R000060689 |
| Scientific Title | European Association of Cardiovascular Imaging Multiple and Mixed Valvular Diseases Study (EACVI-MMVD study) |
| Date of disclosure of the study information | 2024/01/31 |
| Last modified on | 2024/11/25 11:31:48 |
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Basic information
Public title
European Association of Cardiovascular Imaging Multiple and Mixed Valvular Diseases Study (EACVI-MMVD study)
Acronym
European Association of Cardiovascular Imaging Multiple and Mixed Valvular Diseases Study (EACVI-MMVD study)
Scientific Title
European Association of Cardiovascular Imaging Multiple and Mixed Valvular Diseases Study (EACVI-MMVD study)
Scientific Title:Acronym
EACVI-MMVD study
Region
| Japan | Asia(except Japan) | North America |
| Europe | Africa |
Condition
Condition
multiple and mixed valvular heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence and prognosis of multiple and mixed valvular heart disease
Basic objectives2
Others
Basic objectives -Others
To investigate the factors that influence the prevalence and prognosis of multiple and mixed valvular heart disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the prevalence of multiple and mixed valvular heart disease at baseline
Key secondary outcomes
The survey will include cardiovascular deaths, non-cardiac deaths, strokes, cardiovascular events, sudden deaths, heart failure hospitalizations, and the presence and nature of treatment in progress.
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) 18 years of age or older at the time of obtaining consent
(2) Patients who have undergone echocardiography and have been diagnosed as having moderate or severe united valvular heart disease.
(3) Patients who have received a thorough explanation of their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the study.
Key exclusion criteria
(1) Patients with a history of valvular surgery with respect to the valve that led to the diagnosis of united valvular disease.
(2) Patients diagnosed with infective endocarditis within 6 months.
(3) Complex congenital heart disease.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Kagiyama |
Organization
Juntendo University
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
kagiyaman@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Kagiyama |
Organization
Juntendo University
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
kagiyaman@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
Medical Research Ethics Committee
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3814-5672
hongo-rinri@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
順天堂大学医学部附属順天堂医院（東京都）
Juntendo University Hospital（Tokyo）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 10 | 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
The primary institution in Japan is Juntendo University and the primary institution worldwide is the Lariboisiere Hospital in France.
The following parameters are collected
(1) Basic information on study subjects
(2) Baseline laboratory information
(3) Existence and details of treatment during the course of the disease
(4) CT/MRI images for selected patients
(5) Laboratory information during the course of the study: Echocardiography at 1, 2, 3, and 5 years in patients who are able to do so.
(6) Endpoints: The primary endpoint will be the prevalence of united valvular heart disease at baseline. Secondary endpoints will include cardiovascular death, non-cardiac death, stroke, cardiovascular events, sudden death, heart failure hospitalization, and presence and nature of treatment during the course of the study.
Management information
Registered date
| 2024 | Year | 01 | Month | 30 | Day |
Last modified on
| 2024 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060689
