UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032167 |
|---|---|
| Receipt number | R000036695 |
| Scientific Title | Myocardial Quantitative Evaluation using Cardiac Magnetic Resonance Imaging |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2019/02/28 18:01:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Myocardial Quantitative Evaluation using Cardiac Magnetic Resonance Imaging
Acronym
Myocardial Quantitative Evaluation using Cardiac Magnetic Resonance Imaging
Scientific Title
Myocardial Quantitative Evaluation using Cardiac Magnetic Resonance Imaging
Scientific Title:Acronym
Myocardial Quantitative Evaluation using Cardiac Magnetic Resonance Imaging
Region
| Japan |
Condition
Condition
Cardiomyopathy
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To make reference value of myocardial T1, T2 and T2* at 1.5T MR scanner.
Basic objectives2
Others
Basic objectives -Others
To make reference value
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Average, Standard deviation, and 95% Confidence Interval of myocardial T1, T2 and T2* value
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
| 20 | years-old | < |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy without cardiovascular disease
2. Subject who consent to participation
Key exclusion criteria
1. Cannot obtain the consent from subject him/herself
2. Cannot keep a spine position for more than 30 minutes
3. Cannot hold breath for 30 seconds.
4. Arrhythmia.
5. Subject with metallic implants.
6. Claustrophobic.
7. Hypertension, diabetes, or dyslipidemia
8. Body mass index > 30 kg/m2
9. Past history of chemotherapy or radiotherapy
10. Suspected pregnancy
11. Past history of thoracic surgery
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenobu Takagi |
Organization
Iwate Medical University
Division name
Department of Radiology
Zip code
Address
19-1, Uchimaru, Morioka, Iwate, Japan
TEL
019-651-5111
hdnb69tkg@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidenobu Takagi |
Organization
Iwate Medical University
Division name
Department of Radiology
Zip code
Address
19-1, Uchimaru, Morioka, Iwate, Japan
TEL
019-651-5111
Homepage URL
hdnb69tkg@gmail.com
Sponsor or person
Institute
Department of Radiology, Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Radiology, Iwate Medical 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
Address
Tel
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
岩手医科大学病院 循環器医療センター
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | 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
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 01 | Month | 31 | Day |
Other
Other related information
This study enrolls 30 healthy subjects without cardiovascular disease.
Primary endpoint includes average, standard deviation and 95% confidence interval of left ventricular myocardial T1, T2 and T2* in healthy subjects.
Detail analises include as follows:
1. Univariate distribution of global left or right ventricular function derived from cine MR imaging.
2. Univariate distribution of systolic volume derived from phage contrast imaging.
3. Univariate distribution of left ventricular myocardial T1, T2 and T2* value
4. Interobserver agreement of left ventricular myocardial T1, T2 and T2* values.
Management information
Registered date
| 2018 | Year | 04 | Month | 09 | Day |
Last modified on
| 2019 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036695
