UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of cardiac involvements in rheumatic diseases : Detecting cardiac magnetic resonance imaging and inflammatory biomarker approach
Title of the study (Brief title)	Assessment of cardiac involvements in rheumatic diseases
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 involvement using a cardiac magnetic resonance imaging approach and to determine its association with disease characteristics in rheumatic diseases patients
Basic objectives2	Others
Basic objectives -Others	relation between inflammatory biomarker and cardiac involvement in rheumatic diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We explore the association of cardiac MRI abnormalities with rheumatic disease activity and severity measures.
Key secondary outcomes	Association of cardiac involvement, detecting by a cardiac MRI, with inflammatory biomarker

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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	80 years-old >
Gender	Male and Female
Key inclusion criteria	patient, diagnosed with rheumatic disease, without cardiac lesions
Key exclusion criteria	Participants were excluded if they had prior self-reported, physician-diagnosed cardiovascular events or procedures, such as myocardial infarction, angioplasty, and congestive heart failure. Diabetes(HbA1c > 6.1 %), hypertension(systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg), dyslipidemia(LDL cholesterol levels > 140 mg/dL, HDL cholesterol levels < 40 mg/dL, triglyceride levels > 150 mg/dL) were excluded. Furthermore, exclusions were patients who were contraindicated of MRI contrast agent, and who couldn't examine MRI e.g. people containing the cardiac pace maker and so on.
Target sample size	132

Research contact person
Name of lead principal investigator	Kaita Sugiyama
Organization	Nihon University Itabashi Hospital
Division name	rheumatology
Address	30-1 Ooyaguchikamimachi Itabashi-ku Tokyo Japan
TEL	03-3972-8111
Email	kaita_sugiyama@yahoo.co.jp

Public contact
Name of contact person	Akiko Hirama
Organization	Nihon University Itabashi Hospital
Division name	rheumatology
Address	30-1 Ooyaguchikamimachi Itabashi-ku Tokyo Japan
TEL	03-3972-8111
Homepage URL
Email	kaita_sugiyama@yahoo.co.jp

Sponsor
Institute	Nihon University Itabashi Hospital
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 Itabashi Hospital
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 05 Month 27 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 02 Month 05 Day
Anticipated trial start date	2016 Year 02 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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 05 Month 27 Day
Last modified on	2016 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025930