UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049626 |
|---|---|
| Receipt number | R000054826 |
| Scientific Title | Coronary flow reserve evaluated by phase-contrast cine magnetic resonance imaging of the coronary sinus: A Meta-analysis |
| Date of disclosure of the study information | 2022/11/28 |
| Last modified on | 2023/11/29 09:44:09 |
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Basic information
Public title
Coronary flow reserve evaluated by phase-contrast cine magnetic resonance imaging of the coronary sinus: A Meta-analysis
Acronym
Coronary flow reserve evaluated by phase-contrast cine magnetic resonance imaging of the coronary sinus: A Meta-analysis
Scientific Title
Coronary flow reserve evaluated by phase-contrast cine magnetic resonance imaging of the coronary sinus: A Meta-analysis
Scientific Title:Acronym
Coronary flow reserve evaluated by phase-contrast cine magnetic resonance imaging of the coronary sinus: A Meta-analysis
Region
| Japan |
Condition
Condition
Coronary artery disease, cardiomyopathies, heart failure etc.
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Phase-contrast cine magnetic resonance imaging (MRI) of the coronary sinus has emerged as a non-invasive method to measure coronary sinus flow (CSF) and coronary flow reserve (CFR). To date, the clinical utility of this method is not well known. Therefore, we will perform a systematic review and meta-analysis to clarify the clinical value of MRI-derived CFR for various cardiovascular diseases.
Basic objectives2
Others
Basic objectives -Others
Phase-contrast cine magnetic resonance imaging (MRI) of the coronary sinus has emerged as a non-invasive method to measure coronary sinus flow (CSF) and coronary flow reserve (CFR). To date, the clinical utility of this method is not well known. Therefore, we will perform a systematic review and meta-analysis to clarify the clinical value of MRI-derived CFR for various cardiovascular diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will perform a comparison of MRI-derived CFR between various cardiovascular diseases (stable coronary artery disease (CAD), hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM), etc.) and control subjects.
In patients with stable CAD, we will assess the prognostic value of MRI-derived CFR for predicting major adverse cardiac events (MACE).
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
We will search electronic databases of PubMed, Web of Science Core Collection, Cochrane advanced search, and EMBASE, using the word "coronary artery disease", "CFR", "cardiomyopathy" etc.
We will perform meta-analysis of relevant papers.
Key exclusion criteria
Articles without sufficient data.
Articles written by language other than English
Conference abstract
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kato |
| Middle name | |
| Last name | Shingo |
Organization
Yokohama City University
Division name
Department of Diagnostic Radiology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawaku, Yokohama
TEL
0457872800
sk513@yokohama-cu.ac.jp
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
236-0004
Address
3-9, Fukuura, Kanazawaku, Yokohama
TEL
0457872800
Homepage URL
sk513@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Self funding
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
| 2022 | Year | 11 | 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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Perform meta-analysis in accordance with the protocol.
Management information
Registered date
| 2022 | Year | 11 | Month | 28 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054826
