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 2021/12/21 14:55:48

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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

Email

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


Email

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

Email

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


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

Open public recruiting

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

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 06 Month 21 Day

Last modified on

2021 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050929


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name