UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044612 |
|---|---|
| Receipt number | R000050929 |
| Scientific Title | Validation of quantitative analysis method for myocardial blood flow using 3 Tesla myocardial perfusion MRI |
| Date of disclosure of the study information | 2021/06/21 |
| Last modified on | 2025/03/12 14:36:20 |
* 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
Validation of quantitative analysis method for myocardial blood flow using 3 Tesla myocardial perfusion MRI
Acronym
Quantitative analysis method of myocardial perfusion MRI
Scientific Title
Validation of quantitative analysis method for myocardial blood flow using 3 Tesla myocardial perfusion MRI
Scientific Title:Acronym
Quantitative analysis method of myocardial perfusion MRI
Region
| Japan |
Condition
Condition
Patients with known or suspected chronic coronary artery disease
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In a pilot group, myocardial blood flow (MBF) determined by MRI will be compared with 15O-H2O PET to determine whether there are systematic errors in MBF. If a systematic error in MBF is found in the pilot group, a correction formula will be calculated and validated in a different group (validation group).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In a pilot group, myocardial blood flow (MBF) determined by MRI will be compared with 15O-H2O PET to determine whether there are systematic errors in MBF. If a systematic error in MBF is found in the pilot group, a correction formula will be calculated and validated in a different group (validation group).
Key secondary outcomes
(1) Myocardial perfusion reserve (MPR) will be compared between quantitative myocardial perfusion MRI and 15O-H2O PET.
(2) Diagnostic value of MBF and MPR determined by quantitative myocardial perfusion MRI will be investigated using coronary angiography, fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) as references, in patients undergoing coronary angiography.
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
15O-H2O myocardial perfusion PET
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
(1) Patients with chronic coronary artery disease or suspected coronary artery disease who are referred for cardiac MRI following the clinical indication.
(2) Adult patients aged 20 years or older at the time of MRI
(3) Patients who have given written informed consent for participation in the study, including 15O-H2O myocardial perfusion PET.
Key exclusion criteria
1) Patients with contraindications to the use of gadolinium contrast media
2) Patients with contraindications to ATP
3) Patients with severe claustrophobia
4) Patients with arrhythmias such as persistent atrial fibrillation or premature ventricular contraction
5) Patients who are unable to follow instructions to breath holding
6) Patients in an extremely poor general condition
7) Women who are pregnant or with suspected pregnancy
8) Patients with devices that are not MRI compatible
9) Patients with MRI-compatible devices (pacemakers, ICDs) that affect the quality of the MRI images
10) Patients who have had a cardiovascular event, revascularization procedure, change or addition of medication between cardiac MRI and myocardial perfusion PET.
11) Patients who are judged by the principal investigator or sub-investigator to be unsuitable for participation in the study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Ishida |
Organization
Mie University Hospital
Division name
Department of Radiology
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie
TEL
059-231-5029
mishida@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Ishida |
Organization
Mie University Hospital
Division name
Department of Radiology
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie
TEL
059-231-5029
Homepage URL
mishida@med.mie-u.ac.jp
Sponsor or person
Institute
Department of Radiology,
Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Radiology,
Mie University Hospital
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
Mie University Hospital
Address
2-174, Edobashi, Tsu, Mie
Tel
059-231-5045
kk-sien@med.mie-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
| 2021 | Year | 06 | Month | 21 | 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
41
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
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 11 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 11 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 11 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 21 | Day |
Last modified on
| 2025 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050929
