UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025067 |
|---|---|
| Receipt number | R000028839 |
| Scientific Title | Quantitative evaluation of T1 shortening in myocardium and left ventricle cavity by three different macrocyclic gadolinium based contrast agents |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2021/03/25 09:20:37 |
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Basic information
Public title
Quantitative evaluation of T1 shortening in myocardium and left ventricle cavity by three different macrocyclic gadolinium based contrast agents
Acronym
Quantitative evaluation of T1 shortening in heart by three different gadolinium based contrast agents
Scientific Title
Quantitative evaluation of T1 shortening in myocardium and left ventricle cavity by three different macrocyclic gadolinium based contrast agents
Scientific Title:Acronym
Quantitative evaluation of T1 shortening in heart by three different gadolinium based contrast agents
Region
| Japan |
Condition
Condition
Heart disease
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Late gadolinium enhancement (LGE) is widely used for clinical cardiac magnetic resonance imaging (CMR). Because LGE employs inversion recovery (IR) sequences, it would be sensitive for the difference in T1 relaxation times between normal myocardium and cardiac lesions. The aim of this study is to investigate the effect of three different macrocyclic gadolinium-based contrast agents (mGBCA) on T1 shortening in the myocardium and left ventricle (LV).
Basic objectives2
Others
Basic objectives -Others
Assessment of the ability to enhance by contrast agents for magnetic resonance imaging
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
T1 mapping was conducted using modified look-locker inversion recovery (MOLLI) sequences to measure the T1 relaxation time values of the myocardium and LV (1). Regions of Interest were drawn on the short axis images of areas of the myocardium without lesion involvement, at the LV septal/inferior walls, and in the LV cavity. An inversion scout sequence was also acquired seven min after mGBCA administration. Null points were defined as the inversion times (TI) that showed the lowest intensities of the myocardium and LV in each patient. The biological parameters of ejection fraction, estimated glomerular filtration rate, hematocrit, and heart rate were also compared across the three groups.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Patients who underwent cardiac magnetic resonance imaging with T1 mapping before and after administration of gaddolinium contrast agents
Key exclusion criteria
- Examinations without T1 mapping sequence
- Diffuse myocardial lesion
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Nakajima |
| Middle name | |
| Last name | Takahito |
Organization
Gunma University
Division name
Diagnostic Radiology and Nuclear Medicine
Zip code
3718911
Address
3-39-22, Showa, Maebashi, Gunma, Japan
TEL
027-220-8401
sojin@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Nakajima |
| Middle name | |
| Last name | Takahito |
Organization
Gunma University Hospital
Division name
Diagnostic Radiology and Nuclear Medicine
Zip code
3718911
Address
3-39-22, Showa, Maebashi, Gunma, Japan
TEL
027-220-8401
Homepage URL
sojin@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma 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
Gunma University
Address
3-39-22, Showa, Maebashi, Gunma, Japan
Tel
+81272208401
sojin@gunma-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
| 2016 | Year | 12 | 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
50
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Plans for publications and presentations
Management information
Registered date
| 2016 | Year | 11 | Month | 30 | Day |
Last modified on
| 2021 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028839
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| Registered date | File name |
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