UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022503 |
|---|---|
| Receipt number | R000025930 |
| Scientific Title | Assessment of cardiac involvements in rheumatic diseases : Detecting cardiac magnetic resonance imaging and inflammatory biomarker approach |
| Date of disclosure of the study information | 2016/05/27 |
| Last modified on | 2016/05/27 19:22:35 |
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Basic information
Public title
Assessment of cardiac involvements in rheumatic diseases : Detecting cardiac magnetic resonance imaging and inflammatory biomarker approach
Acronym
Assessment of cardiac involvements in rheumatic diseases
Scientific Title
Assessment of cardiac involvements in rheumatic diseases : Detecting cardiac magnetic resonance imaging and inflammatory biomarker approach
Scientific Title:Acronym
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
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
| 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
| 1st name | |
| Middle name | |
| Last name | Kaita Sugiyama |
Organization
Nihon University Itabashi Hospital
Division name
rheumatology
Zip code
Address
30-1 Ooyaguchikamimachi Itabashi-ku Tokyo Japan
TEL
03-3972-8111
kaita_sugiyama@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Hirama |
Organization
Nihon University Itabashi Hospital
Division name
rheumatology
Zip code
Address
30-1 Ooyaguchikamimachi Itabashi-ku Tokyo Japan
TEL
03-3972-8111
Homepage URL
kaita_sugiyama@yahoo.co.jp
Sponsor or person
Institute
Nihon University Itabashi Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2016 | Year | 02 | Month | 05 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025930
