UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054806 |
|---|---|
| Receipt number | R000062629 |
| Scientific Title | A Prospective Multicenter Study to Evaluate the Prognostic Value of Coronary Flow Reserve on MRI in Patients with Coronary Artery Disease |
| Date of disclosure of the study information | 2024/06/28 |
| Last modified on | 2024/06/28 10:46:20 |
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Basic information
Public title
A Prospective Multicenter Study to Evaluate the Prognostic Value of Coronary Flow Reserve on MRI in Patients with Coronary Artery Disease
Acronym
A Prospective Multicenter Study to Evaluate the Prognostic Value of Coronary Flow Reserve on MRI in Patients with Coronary Artery Disease
Scientific Title
A Prospective Multicenter Study to Evaluate the Prognostic Value of Coronary Flow Reserve on MRI in Patients with Coronary Artery Disease
Scientific Title:Acronym
A Prospective Multicenter Study to Evaluate the Prognostic Value of Coronary Flow Reserve on MRI in Patients with Coronary Artery Disease
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Medicine in general | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the predictive ability of coronary flow reserve (CFR) measured by MRI for cardiovascular events in patients with coronary artery disease in a prospective multicenter study.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major cardiovascular events are defined as cardiac death, acute coronary syndrome, hospitalization for heart failure, ventricular arrhythmia requiring cardioversion, and coronary revascularization procedures. Patients will be enrolled in the study at 1, 2, and 3 years post-enrollment to determine the presence or absence of events. Patients will be classified into CFR severely depressed (<2.0) and CFR normal (=/>2.0) groups, and Kaplan Meier and Cox hazard analyses will be performed to assess prognostic value for major cardiovascular events.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be considered 1) Patients who are at least 20 years old and less than 90 years old. 2) Patients of any gender. 3) Patients with coronary artery disease (angina pectoris or myocardial infarction) diagnosed prior to MRI examination. 4) Patients who are clinically judged to have myocardial ischemia and for whom cardiac MRI is ordered for close examination.
Key exclusion criteria
Patients who violate any of the following will not be included in this study. 1) Patients who could not complete MRI due to claustrophobia, etc. 2) Patients for whom ATP administration is contraindicated (bronchial asthma, drug allergy, etc.) 3) Patients who have difficulty in analysis due to a significant decrease in image quality caused by an irregular pulse, etc. 4) Patients whose consent cannot be obtained. 5) Patients who have difficulty understanding the contents of this study.
Target sample size
253
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawaku, Yokohama
TEL
0457872800
shingo.m12226@gmail.com
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Yokohama City University Hospital
Division name
Department of Diagnostic Radiology
Zip code
2360004
Address
3-9, Fukuura, Kanazawaku, Yokohama
TEL
0457872800
Homepage URL
shingo.m12226@gmail.com
Sponsor or person
Institute
Yokohama City University, Department of Diagnostic Radiology
Institute
Department
Personal name
Shingo Kato
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Yokohama City University
Address
3-9, Fukuura, Kanazawaku, Yokohama
Tel
0457872800
sk513@yokohama-cu.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
| 2024 | Year | 06 | Month | 28 | 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
| 2024 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 06 | Month | 28 | Day |
Last modified on
| 2024 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062629
