UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037608 |
|---|---|
| Receipt number | R000042869 |
| Scientific Title | Quantification of myocardial fibrosis with cardiovascular magnetic resonance imaging in patients with muscular dystrophy |
| Date of disclosure of the study information | 2019/08/06 |
| Last modified on | 2020/09/07 12:39:57 |
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Basic information
Public title
Quantification of myocardial fibrosis with cardiovascular magnetic resonance imaging in patients with muscular dystrophy
Acronym
Quantification of myocardial fibrosis with CMR in muscular dystrophy
Scientific Title
Quantification of myocardial fibrosis with cardiovascular magnetic resonance imaging in patients with muscular dystrophy
Scientific Title:Acronym
Quantification of myocardial fibrosis with CMR in muscular dystrophy
Region
| Japan |
Condition
Condition
Muscular dystrophy
Classification by specialty
| Cardiology | Neurology | Pediatrics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our objective is to evaluate and predict the progression of myocardial fibrosis in patients with muscular dystrophy or suspected muscular dystrophy carriers using cardiovascular magnetic resonance imaging including T1 mapping.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The prespecified primary outcome of the study is to assess improvement of left ventricular ejection fraction 24 months after the first cardiovascular magnetic resonance imaging in patients with muscular dystrophy, suspected muscular dystrophy carriers, and volunteers.
Key secondary outcomes
The prespecified secondary outcomes of the study are as follows:
1. To assess predictors of the occurrence of left ventricular dysfunction (left ventricular ejection fraction <50% or decrease by 5% or more per year) in patients with muscular dystrophy or suspected muscular dystrophy carriers.
2. To assess the association between absolute change and percent change in left ventricular ejection fraction per year and baseline values of the extent of late gadolinium enhancement, T1 mapping measurements, circumferential strain analysis by the tagging method, coronary flow reserve, echocardiography measurements, and biomarkers.
3. To assess the cross-sectional and longitudinal association between left ventricular ejection fraction, the extent of late gadolinium enhancement, T1 mapping measurements, circumferential strain analysis by the tagging method, coronary flow reserve, echocardiography measurements, and biomarkers.
4. To assess predictors of all-cause death, cardiovascular death, left ventricular assist device implantation, cardiac transplantation, heart failure admission, life-threatening arrhythmia (ventricular tachycardia, ventricular fibrillation).
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient group:
1. Patients 6 years of age or older are eligible.
2. Patients diagnosed as Duchenne muscular dystrophy, Becker muscular dystrophy, Emery-Dreifuss muscular dystrophy, limb-girdle muscular dystrophy, or myotonic dystrophy are eligible.
3. Patients who are scheduled for cardiac magnetic resonance imaging are eligible.
4. Patients who can be scheduled for cardiac magnetic resonance imaging 24 months after the first scan are eligible.
5. Patients who provided informed consent, parental permission, or assent are eligible.
Muscular dystrophy carrier group:
1. Proven or suspected muscular dystrophy carriers 20 years of age or older are eligible.
2. Proven or suspected carriers of Duchenne or Becker muscular dystrophy who have at least one first-degree male relatives with a previously established Duchenne or Becker muscular dystrophy diagnosis.
3. Proven or suspected carriers who are scheduled for cardiac magnetic resonance imaging are eligible.
4. Proven or suspected carriers who can be scheduled for cardiac magnetic resonance imaging 24 months after the first scan are eligible.
5. Proven or suspected carriers who provided informed consent are eligible.
Normal volunteer group:
1. Persons 20 years of age or older are eligible.
2. Persons without cardiac or kidney disease are eligible.
3. Persons who provided informed consent are eligible.
Key exclusion criteria
1. Patients with impaired renal function (estimated glomerular filtration rate <30 mL/min/1.73m2)
2. Patients with claustrophobia
3. Patients expected to live a year or less
4. Patients who contact persons judge as ineligible for this study
Target sample size
420
Research contact person
Name of lead principal investigator
| 1st name | Tadao |
| Middle name | |
| Last name | Aikawa |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15, Nishi-7, Kita-ku, Sapporo
TEL
011-706-6973
aikawatadao@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Tadao |
| Middle name | |
| Last name | Aikawa |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15, Nishi-7, Kita-ku, Sapporo
TEL
011-706-6973
Homepage URL
aikawatadao@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Japan Heart Foundation
Watanabe Foundation
Japan Intractable Diseases Research Foundation
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Clinical Research Administration, Hokkaido University Hospital
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, 060-8648, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/mrms/advpub/0/advpub_bc.2020-0069/_article/-char/en
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/mrms/advpub/0/advpub_bc.2020-0069/_article/-char/en
Number of participants that the trial has enrolled
11
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 09 | Month | 07 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 27 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 27 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 27 | Day |
Other
Other related information
In this prospective observational study, we evaluated left ventricular ejection fraction, the extent of late gadolinium enhancement, T1 mapping measurements (native T1 and extracellular volume fraction mapping), coronary flow reserve, circumferential strain analysis using cardiac magnetic resonance imaging, echocardiography measurements, and biomarkers to assess the primary and secondary outcomes.
Management information
Registered date
| 2019 | Year | 08 | Month | 06 | Day |
Last modified on
| 2020 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042869
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| Registered date | File name |
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| Registered date | File name |
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