UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001549 |
|---|---|
| Receipt number | R000001869 |
| Scientific Title | Use of MRI for early detection of cardiac involvement in patients with sarcoidosis. |
| Date of disclosure of the study information | 2008/12/03 |
| Last modified on | 2014/05/25 22:31:20 |
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Basic information
Public title
Use of MRI for early detection of cardiac involvement in patients with sarcoidosis.
Acronym
Use of MRI for early detection of cardiac involvement in patients with sarcoidosis.
Scientific Title
Use of MRI for early detection of cardiac involvement in patients with sarcoidosis.
Scientific Title:Acronym
Use of MRI for early detection of cardiac involvement in patients with sarcoidosis.
Region
| Japan |
Condition
Condition
Sarcoidosis
Classification by specialty
| Cardiology | Pneumology | Ophthalmology |
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The screening of cardiac involvement about sarcoidosis patients.
The invastigation of the efficacy of cardiac MRI.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
death, the complication of sarcoidosis, the change of therapy
Key secondary outcomes
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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
in/outpatients seen in pulmonary, ophthalmology and dermatology department with histopathological diagnosis of sarcoidosis.
Key exclusion criteria
none
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Nagai |
Organization
Keio university school of medicine
Division name
Cardiology
Zip code
Address
Shinanomachi 35 Shinjuku Tokyo
TEL
03-3353-1211
umc-nagai@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Nagai |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular Medicine
Zip code
Address
5-7-1 Fujishiro dai Suita Osaka
TEL
06-6833-5012
Homepage URL
umc-nagai@hotmail.co.jp
Sponsor or person
Institute
Keio university school of medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2008 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Methods: Sixty one consecutive patients who met the histological and clinical criteria for sarcoidosis, and who did not have signs or symptoms of cardiovascular involvement were prospectively recruited. LGE CMR was performed at the time of enrollment and patients were classified into positive or negative LGE groups based on the findings. The study endpoint was a composite of all cause death, symptomatic arrhythmia, and heart failure necessitating admission.
Results: Patients were predominantly middle aged (57 plusminus 15 years), female (66%), and most had stable disease activity that did not require treatment with immunosuppressants. LGE-CMR detected cardiac involvement in 8 patients (13%). Interventricular septal (IVS) thinning detected by echocardiography was an independent predictor of LGE-CMR-detected cardiac involvement. During the follow-up period of 50 plusmminus 12 months, no significant difference in adverse events was noted between patients in the LGE CMR positive and negative groups.
Conclusions: In sarcoidosis patients without cardiac manifestation, LGE CMR detected cardiac involvement in 13% of patients, but both patients with and without LGE had relatively low event rates.
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
Completed
Date of protocol fixation
| 2008 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 04 | Month | 20 | Day |
Date analysis concluded
| 2014 | Year | 04 | Month | 20 | Day |
Other
Other related information
Not significant
Management information
Registered date
| 2008 | Year | 12 | Month | 03 | Day |
Last modified on
| 2014 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001869
