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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030703
Receipt No. 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 2019/07/09

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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
Email 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
Email pero1995@gmail.com

Sponsor
Institute Nihon University School of Medicine
Institute
Department

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
Email 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 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 Enrolling by invitation
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
2020 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
2019 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034915

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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