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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001549
Receipt No. 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

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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
Email 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
Email umc-nagai@hotmail.co.jp

Sponsor
Institute Keio university school of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001869

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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