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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032167
Receipt No. 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

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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
Email 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
Email hdnb69tkg@gmail.com

Sponsor
Institute Department of Radiology, Iwate Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036695

Research Plan
Registered date File name
2018/05/26 03_研究計画書_T1_v1.0.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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