UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012647 |
|---|---|
| Receipt number | R000014791 |
| Scientific Title | Assessment of cardiac involvements in rheumatoid arthritis using a cardiac magnetic resonance approach |
| Date of disclosure of the study information | 2013/12/21 |
| Last modified on | 2013/12/21 10:42:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Assessment of cardiac involvements in
rheumatoid arthritis using a cardiac
magnetic resonance approach
Acronym
Assessment of cardiac involvements in
rheumatoid arthritis
Scientific Title
Assessment of cardiac involvements in
rheumatoid arthritis using a cardiac
magnetic resonance approach
Scientific Title:Acronym
Assessment of cardiac involvements in
rheumatoid arthritis
Region
| Japan |
Condition
Condition
rheumatoid arthritis
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 RA patients
Basic objectives2
Others
Basic objectives -Others
To detect the influence of Biologics in cardiac function
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
To detect the influence of Biologics in cardiac function
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
tocilizmab
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
Female
Key inclusion criteria
All RA patients were recruited at our center from December 2010 to May 2012. All patients met the 2010 American College of Rheumatology/European League Against Rheumatism criteria for RA. Moderate to severe active RA patients [using the Disease Activity Score in 28 joints (DAS28) ; cut off 3.2] receiving methotrexate (MTX) who were candidates for tocilizumab (TCZ) without prior use of any biologic were included in the study.
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. 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 are greater than 140 mg/dL, an HDL cholesterol level<40 mg/dL, or a triglyceride level>150 mg/dL).
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kobayashi Hitomi |
Organization
Itabashi Chuo Medical Center
Division name
rheumatology
Zip code
Address
2-12-7 Azusawa Itabashi-ku Tokyo Japan
TEL
0339760572
haraoka@pero.name
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isamu Yokoe |
Organization
internal medicine
Division name
rheumatology
Zip code
Address
Itabashi
TEL
0339760572
Homepage URL
pero1995@gmail.com
Sponsor or person
Institute
Itabashi Chuo Medical Center
Institute
Department
Personal name
Funding Source
Organization
Itabashi Chuo Medical Center
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
| 2013 | Year | 12 | Month | 21 | 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
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 21 | Day |
Last modified on
| 2013 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014791
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
