UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of cardiac involvements in rheumatic diseas using a cardiac magnetic resonance approach
Title of the study (Brief title)	Assessment of cardiac involvements in reumatic disease
Region	Japan

Condition
Condition	rheumatic disease
Classification by specialty	Clinical immunology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We sought to assess cardiac involvment using a cardiac magnetic resonance imaging and to determine its association with disease activity, patients characterstics, and biomaker in rheumatic disease patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We explored the association of cardic MRI abnomalities with disease activity, patients characterstics, and biomaker in rheumatic disease patients
Key secondary outcomes	To detect the influence of treatment agents in cardiac involvements

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <
Age-upper limit	70 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
Target sample size	128

Research contact person
Name of lead principal investigator	Hitomi Kobayashi
Organization	Nihon University School of Medicine
Division name	Division of Hematology and Rheumatology
Address	30-1 Oyaguchi Itabashi-Ward, Tokyo Japan 173-8610
TEL	0339728111
Email	kobayashi.hitomi48@nihon-u.ac.jp

Public contact
Name of contact person	Akiko Hirama
Organization	Nihon University School of Medicine
Division name	Division of Hematology and Rheumatology
Address	30-1 Oyaguchi Itabashi-Ward, Tokyo Japan 173-8610
TEL	0339728111
Homepage URL
Email	hirama.akiko@nihon-u.ac.jp

Sponsor
Institute	Nihon University School of Medicine Division of Hematology and Rheumatology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Nihon University School of Medicine Division of Hematology and Rheumatology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 04 Month 29 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 12 Month 18 Day
Anticipated trial start date	2015 Year 02 Month 20 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Enrolling by invitation

Management information
Registered date	2016 Year 04 Month 29 Day
Last modified on	2016 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025517