UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034915