UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022140 |
|---|---|
| Receipt number | R000025517 |
| Scientific Title | Assessment of cardiac involvements in rheumatic diseas using a cardiac magnetic resonance approach |
| Date of disclosure of the study information | 2016/04/29 |
| Last modified on | 2016/04/29 17:15:13 |
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Basic information
Public title
Assessment of cardiac involvements in rheumatic diseas using a cardiac magnetic resonance approach
Acronym
Assessment of cardiac involvements in reumatic disease
Scientific Title
Assessment of cardiac involvements in rheumatic diseas using a cardiac magnetic resonance approach
Scientific Title:Acronym
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
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
| 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
| 1st name | |
| Middle name | |
| Last name | Hitomi Kobayashi |
Organization
Nihon University School of Medicine
Division name
Division of Hematology and Rheumatology
Zip code
Address
30-1 Oyaguchi Itabashi-Ward, Tokyo Japan 173-8610
TEL
0339728111
kobayashi.hitomi48@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Hirama |
Organization
Nihon University School of Medicine
Division name
Division of Hematology and Rheumatology
Zip code
Address
30-1 Oyaguchi Itabashi-Ward, Tokyo Japan 173-8610
TEL
0339728111
Homepage URL
hirama.akiko@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Division of Hematology and Rheumatology
Institute
Department
Personal name
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)
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 | 04 | Month | 29 | 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
| 2014 | Year | 12 | Month | 18 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025517
