UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057332 |
|---|---|
| Receipt number | R000065530 |
| Scientific Title | Registry-based Research of Extracellular Volume Fraction (ECV) Assessed by Cardiac CT in patients with cardiovascular disease |
| Date of disclosure of the study information | 2025/03/19 |
| Last modified on | 2025/03/18 22:33:26 |
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Basic information
Public title
Registry-based Research of Extracellular Volume Fraction (ECV) Assessed by Cardiac CT in patients with cardiovascular disease
Acronym
Observational Study on Extracellular Volume using Cardiac CT
Scientific Title
Registry-based Research of Extracellular Volume Fraction (ECV) Assessed by Cardiac CT in patients with cardiovascular disease
Scientific Title:Acronym
Observational Study on Extracellular Volume using Cardiac CT
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Myocardial fibrosis and edema are recognized as pathological changes in a wide range of cardiac conditions, including coronary artery disease and cardiomyopathies. Accurate assessment of these changes is known to be useful for diagnosing heart diseases and predicting their prognosis. Extracellular volume fraction (ECV), measured non-invasively, has been established as a valuable indicator for evaluating the extent of myocardial fibrosis or edema. This study aims to investigate the relationship between ECV assessed by cardiac CT and patient characteristics, as well as findings from other invasive and non-invasive examinations (including echocardiography, coronary angiography, and myocardial biopsy). By clarifying the diagnostic utility, risk stratification potential, therapeutic efficacy assessment, and prognostic value of ECV in heart diseases, this study seeks to contribute to the optimization of individualized disease prevention and treatment strategies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
None
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
Patients who underwent a cardiac CT scan for a detailed evaluation of heart disease and were eligible for ECV assessment.
Key exclusion criteria
Patients for whom cardiac CT and its corresponding ECV assessment cannot be performed.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Tsunekazu |
| Middle name | |
| Last name | Kakuta |
Organization
Tsuchiura Kyodo General Hospital
Division name
Department of Cardiovascular Medicine
Zip code
300-0028
Address
4-1-1, Otsuno, Tsuchiura, Ibaraki, Japan
TEL
+81-29-830-3711
kaz@joy.email.ne.jp
Public contact
Name of contact person
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Kanaji |
Organization
Tsuchiura Kyodo General Hospital
Division name
Department of Cardiovascular Medicine
Zip code
300-0028
Address
4-1-1, Otsuno, Tsuchiura, Ibaraki, Japan
TEL
+81-29-830-3711
Homepage URL
yoshihisa.kanaji@gmail.com
Sponsor or person
Institute
Tsuchiura Kyodo General Hospital
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
Ethics Committee of Tsuchiura Kyodo General Hospital
Address
4-1-1, Otsuno, Tsuchiura, Ibaraki, Japan
Tel
+81-29-830-3711
general@tkgh.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
| 2025 | Year | 03 | Month | 19 | 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
| 2025 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A registry-based study encompassing both retrospective data from cardiac CT scans performed since 2023 and prospective data from future cardiac CT examinations.
Management information
Registered date
| 2025 | Year | 03 | Month | 18 | Day |
Last modified on
| 2025 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065530
