UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055552 |
|---|---|
| Receipt number | R000063484 |
| Scientific Title | Observational Study for the Prognosis and diagnostic accuracy of Triglycerides Deposit Cardiomyovasculopathy |
| Date of disclosure of the study information | 2024/09/20 |
| Last modified on | 2024/09/20 00:42:49 |
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Basic information
Public title
Observational Study for the Prognosis and diagnostic accuracy of Triglycerides Deposit Cardiomyovasculopathy
Acronym
Observational Study for Triglycerides Deposit Cardiomyovasculopathy
Scientific Title
Observational Study for the Prognosis and diagnostic accuracy of Triglycerides Deposit Cardiomyovasculopathy
Scientific Title:Acronym
Observational Study for Triglycerides Deposit Cardiomyovasculopathy
Region
| Japan |
Condition
Condition
Triglyceride deposit cardiomyovasculopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to elucidate the relationship between various diagnostic testing, clinical findings, and disease prognosis in triglyceride deposit cardiomyovasculopathy. Another purpose of the study include clarifying the correlation between pathological findings that can substantiate a definitive diagnosis and various imaging modalities that assist in diagnosis, aiming to improve diagnostic accuracy.
Basic objectives2
Others
Basic objectives -Others
Evaluate the usefulness of unestablished diagnostic methods in comparison with existing diagnostic criteria for the diagnosis of triglyceride deposit cardiomyovasculopathy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite endpoint including lethal arrhythmia, heart failure hospitalization, cardiovascular death, and all-cause mortality
Key secondary outcomes
Arrhythmic events including bradycardia, supraventricular tachycardia, and ventricular tachycardia
Heart failure hospitalization
Any hospitalization for the cardiovascular management, excluding heart failure
Cardiovascular death
All-cause mortality
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient providing written informed consent
Key exclusion criteria
not applicable
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Suwa |
Organization
Hamamatsu University School of Medicine
Division name
Internal Medicine III, Division of Cardiology
Zip code
431-3192
Address
1-20-1 Handayama Chuou-ku, Hamamatsu
TEL
0534352267
k-suwa@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Suwa |
Organization
Hamamatsu University School of Medicine
Division name
Internal Medicine III, Division of Cardiology
Zip code
431-3192
Address
1-20-1 Handayama Chuou-ku, Hamamatsu
TEL
0534352267
Homepage URL
k-suwa@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama Chuou-ku, Hamamatsu
Tel
0534352194
kenkyou.k@hama-med.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 | 09 | Month | 20 | 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 | 12 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study targets patients in whom triglyceride deposit cardiomyovasculopathy (TGCV) is a differential diagnosis and who are scheduled to undergo I-123 BMIPP scintigraphy. Using current diagnostic criteria, patients will be classified into TGCV and non-TGCV groups. Observational parameters include cardiac MRI (cine, strain, late gadolinium enhancement, T1 mapping, T2 mapping, MR spectroscopy), cardiac CT (coronary artery evaluation, myocardial fat deposition assessment), 99mTc-MIBI resting myocardial scintigraphy (including washout rate), and I-123 BMIPP (including washout rate and dynamic SPECT). The study aims to clarify the relationship between these parameters and the composite endpoint, the primary outcome measure (lethal arrhythmia, heart failure hospitalization, cardiovascular death, all-cause mortality).
Management information
Registered date
| 2024 | Year | 09 | Month | 20 | Day |
Last modified on
| 2024 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063484
