UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054643 |
|---|---|
| Receipt number | R000062436 |
| Scientific Title | Optimal parameters for left ventricular systolic data acquisition for T1 mapping in cardiac MRI |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/06/12 16:51:23 |
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Basic information
Public title
Optimal parameters for left ventricular systolic data acquisition for T1 mapping in cardiac MRI
Acronym
Optimal parameters for left ventricular systolic data acquisition for T1 mapping in cardiac MRI
Scientific Title
Optimal parameters for left ventricular systolic data acquisition for T1 mapping in cardiac MRI
Scientific Title:Acronym
Optimal parameters for left ventricular systolic data acquisition for T1 mapping in cardiac MRI
Region
| Japan |
Condition
Condition
Cardiomyopathy
Muscular dystrophy
Normal volunteer
Classification by specialty
| Cardiology | Pediatrics | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the optimal parameters for left ventricular systolic data acquisition for T1 mapping in cardiac MRI
Basic objectives2
Others
Basic objectives -Others
To study the differences in image quality assessment and T1 values obtained by patient background in left ventricular systolic data acquisition for cardiac MRI T1 mapping.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of the image quality of T1 mapping
Key secondary outcomes
Differences in Native T1 values (pre-contrast T1 values) and Extracellular Volume Fraction (ECV) according to imaging parameters
Optimal imaging parameters by arrhythmia type, heart rate and age
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
We acquire cardiac MRI T1-mapping data at nine ventricular systolic and conventional midsystolic parameters.
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
| 7 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Normal volunteer
(1) Persons with no previous history of cardiac abnormalities such as electrocardiograms, chest radiographs or ultrasounds.
(2) Persons with no symptoms of suspected heart disease.
(3) Individuals without a history of diabetes or hypertension.
(4) Persons who are at least 18 years of age at the time consent is obtained.
(5) Persons who can obtain written consent for this study from the subject.
Clinical case 1: High heart rate and arrhythmia
(1) Patients who have undergone cardiac MRI examination due to suspected myocardial disease.
(2) Patients with a heart rate of 80 bpm. or more at the time of examination or those with arrhythmias such as atrial fibrillation or ventricular arrhythmia.
(3) Patients whose condition at the time of the examination is stable and not acute
(4) Not complicated by other serious cardiac or systemic diseases (e.g. end-stage heart failure, serious renal failure)
(5) The subject is at least 18 years of age
(6) Who can obtain written consent for this study from the subject him/herself.
Clinical case 2: Children
(1) Those diagnosed with muscular dystrophy
(2) Who have a resting heart rate of 100 bpm or greater
(3) At least 7 years of age and less than or equal to 20 years of age
(4) Subjects who are able to provide written consent for this study from themselves and their surrogates.
Key exclusion criteria
Normal volunteer
People with claustrophobia, MRI non-compliant internal body metals
People with psychosis or dementia requiring treatment
Anyone deemed by the investigator to be unsuitable for the study.
Clinical case 1: High heart rate and arrhythmia
People with claustrophobia, MRI non-compliant internal body metals
People with psychosis or dementia requiring treatment
Anyone deemed by the investigator to be unsuitable for the study.
Individuals who cannot use MRI contrast media (Gadolinium contrast media).
Clinical case 2: Children
People with claustrophobia, MRI non-compliant internal body metals
People with psychosis or dementia requiring treatment
Anyone deemed by the investigator to be unsuitable for the study.
Individuals who cannot use MRI contrast media (Gadolinium contrast media).
Target sample size
165
Research contact person
Name of lead principal investigator
| 1st name | HIROMI |
| Middle name | |
| Last name | HASHIMURA |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Radiology
Zip code
6500017
Address
7-5-2, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-6104
h.hashimura@hotmail.co.jp
Public contact
Name of contact person
| 1st name | HIROMI |
| Middle name | |
| Last name | HASHIMURA |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Radiology
Zip code
6500017
Address
7-5-2, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-6104
Homepage URL
h.hashimura@hotmail.co.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Intervention research ethics review committee of Kobe University Hospital
Address
7-5-2, Chuo-ku, Kobe, Hyogo, Japan
Tel
078-382-6999
kainyu@med.kobe-u.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 | 08 | Month | 01 | 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
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 12 | Day |
Last modified on
| 2024 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062436
