UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030703 |
|---|---|
| Receipt number | R000034915 |
| Scientific Title | Assessment of cardiac involvements in rheumatoid arthritis using a cardiac magnetic resonance approach: multicenter prospective study |
| Date of disclosure of the study information | 2018/01/12 |
| Last modified on | 2021/01/08 15:40:32 |
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Basic information
Public title
Assessment of cardiac involvements in rheumatoid arthritis using a cardiac magnetic resonance approach: multicenter prospective study
Acronym
Assessment of cardiac involvements in rheumatoid arthritis
Scientific Title
Assessment of cardiac involvements in rheumatoid arthritis using a cardiac magnetic resonance approach: multicenter prospective study
Scientific Title:Acronym
Assessment of cardiac involvements in rheumatoid arthritis
Region
| Japan |
Condition
Condition
rheumatoid arthritis(RA)
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will consider the following items using non-invasive cardiac MRI.
to identify the frequency and the extent of cardiac involvement in RA patients who do not have any cardiac disorders
Basic objectives2
Others
Basic objectives -Others
to evaluate the effect of biologics and estimate the improvement of prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We explored the associations of cardiac MRI abnormalities with RA disease activity and severity measures.
Key secondary outcomes
We evaluate to detect the influence of Biologics in cardiac function
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)All rheumatic disease patients were over twenty years old and met the American College of Rheumatology criteria.
2)Cardiac symptoms were absent in all subjects.
Key exclusion criteria
Participants were excluded if they had prior self-reported, physician-diagnosed cardiovascular events or procedures, such as myocardial infarction, angioplasty, and CHF. Additional exclusions were diabetes (HbA1c>6.1), hypertension ((systolic blood pressure (BP) >140 mm Hg and/or diastolic BP>90 mm Hg), and dyslipidemia (LDL cholesterol levels >140 mg/dL, an HDL cholesterol level<40 mg/dL, or a triglyceride level>150 mg/dL).History of bronchoconstriction, contraindication to MRI, hypersensivity to gadolinium were absent in all subjects, and others in which the physician deemed inappropriate to enter the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Isamu |
| Middle name | |
| Last name | Yokoe |
Organization
Nihon University School of Medicine
Division name
Division of Hematology and Rheumatology
Zip code
173-8610
Address
30-1 Oyaguchi Itabashi-Ward, Tokyo Japan 173-8610
TEL
0339728111
yokoe@po.kyoundo.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Kobayashi |
Organization
Nihon University School of Medicine
Division name
Division of Hematology and Rheumatology
Zip code
173-8610
Address
30-1 Oyaguchi Itabashi-Ward, Tokyo Japan 173-8610
TEL
0339728111
Homepage URL
pero1995@gmail.com
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
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
Nihon University School of Medicine
Address
30-1 Oyaguchi Itabashi-Ward, Tokyo Japan 173-8610
Tel
0339728111
yokoe@po.kyoundo.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
| 2018 | Year | 01 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All patients will be examined by contrast-enhanced CMR with cine MRI, tagging MRI on a 3.0 T MRI scanner. Multivariate analysis will be performed to assess the relationship between disease activities and biomarkers.
Using cine MRI and tagging MRI of 3.0 Tesla, we will analyze the relationship indicating myocardial disorder and the activity of RA. Since the 3.0 Tesla MRI is not available in our hospital, the examination will be performed at Yaesu clinic. During the observation period, the treatment of RA including the subscription of biological will be performed by the attending physician.
Management information
Registered date
| 2018 | Year | 01 | Month | 05 | Day |
Last modified on
| 2021 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034915
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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