UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006533 |
|---|---|
| Receipt number | R000007744 |
| Scientific Title | Detecting sympathetic denervation and regional myocardial inflammation using 11C-hydroxyephedrine (HED) PET/CT and 18F-fluorodeoxyglucose (FDG) PET/CT and their relationship with arrhythmia in patients with cardiac involvement sarcoidosis and assessment of therapeutic effects |
| Date of disclosure of the study information | 2011/10/30 |
| Last modified on | 2012/10/23 10:59:25 |
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Basic information
Public title
Detecting sympathetic denervation and
regional myocardial inflammation
using 11C-hydroxyephedrine (HED)
PET/CT and 18F-fluorodeoxyglucose
(FDG) PET/CT and their relationship
with arrhythmia in patients with
cardiac involvement sarcoidosis and
assessment of therapeutic effects
Acronym
Detecting sympathetic denervation and
regional myocardial inflammation in patients with cardiac involvement sarcoidosis (CANVAS study)
Scientific Title
Detecting sympathetic denervation and
regional myocardial inflammation
using 11C-hydroxyephedrine (HED)
PET/CT and 18F-fluorodeoxyglucose
(FDG) PET/CT and their relationship
with arrhythmia in patients with
cardiac involvement sarcoidosis and
assessment of therapeutic effects
Scientific Title:Acronym
Detecting sympathetic denervation and
regional myocardial inflammation in patients with cardiac involvement sarcoidosis (CANVAS study)
Region
| Japan |
Condition
Condition
sarcoidosis
Classification by specialty
| Cardiology | Pneumology | Ophthalmology |
| Dermatology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. The primary aim of this study is to detect high risk ventricular tachyarrhythmia patients with cardiac sarcoidosis. For achieving this goal, we will evaluate the association among the regional sympathetic denervation, regional inflammation of foci, and ventricular tachyarrhythmia using 11C HED PET, 18F FDG PET, ambulatory electrocardiogram (AECG) and signal averaged electrocardiogram (SAECG).
2. The secondary aim of this study is to evaluate the steroid treatment effects on regional sympathetic nervous function, regional inflammation, and their associations with clinical findings including AECG and SAECG.
3. Third objectives of the study is to detect T-wave alterations in patients with cardiac sarcoidosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Echo and MRI for evaluating LV function.
SAECG and AECG for evaluating arrhythmia.
Positron emission tomography: 11C Hydroxyephedrine PET for evaluating myocardial sympathetic nervous function.
18-F fluorodeoxyglucose PET for evaluating myocardial and systemic inflammation.
15O labeled water for evaluating myocardial blood flow and coronary resistance.
biomarkers from blood samples.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
5
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
All patients with first diagnosis of cardiac sarcoidosis or without steroid treatment will undergo 11C HED PET/CT,18F FDG PET/CT, 15O-PET water, MIBG, 12 leads ECG, AECG , SAECG and echocardiogram (Echo) before starting corticosteroid therapy and repeat study at 4 weeks after starting corticosteroid therapy. These patients will also have reevaluation 6 to 12 month after the second evaluations.
Sarcoidosis without cardiac involvement will undergo steroid treatment will also repeat the same measurements 4 weeks after the treatment.
Cardiac sarcoidosis but will not have steroid treatment will also repeat the same measurements 12 months later. Sarcoidosis patients without steroid treatment will also repeat the same measurements 12 months later.
Cardiac sarcoidosis with steroid treatment.
Interventions/Control_2
Cardiac sarcoidosis without steroid treatment.
Interventions/Control_3
arcoidosis without cardiac involvement who will have steroid treatement.
Interventions/Control_4
Sarcoidosis without cardiac involvement who will not have steroid treatement.
Interventions/Control_5
Normal control.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Sarcoidosis patient with and without cardiac involvement will be enrolled from the first department of Internal Medicine, Hokkaido University Hospital.
Patients with sarcoidosis met the diagnostic criteria for cardiac sarcoidosis based on Japanese Ministry of Health and Welfare.
Patients without cardiac involvement of sarcoidosis will serve as control.
Age less than 20 when their guardian agrees with the entry.
Key exclusion criteria
Patients with coronary artery disease
Patients with underlying dilated cardiomyopathy or other cardiomyopathies
Life expectancy less than 1 year due to other co-morbidity
Inability to obtain informed consent
pregnant or breast-feeding
Claustrophobia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichiro Yoshinaga, M.D., Ph.D, F.A.C.C.. |
Organization
Hokkaido University Graduate School of Medicine,
Division name
Department of Photobiology
Zip code
Address
Kita-15, Nishi-7, Kita-Ku, Sapporo,
TEL
011-706-5152
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichiro Yoshinaga, M.D., Ph.D, F.A.C.C.. |
Organization
Hokkaido University Graduate School of Medicine,
Division name
Department of Photobiology
Zip code
Address
Kita-15, Nishi-7, Kita-Ku, Sapporo,
TEL
011-706-5152
Homepage URL
kyoshi@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine,
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 30 | 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
This study is currently underway.
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 | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 13 | Day |
Last modified on
| 2012 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007744
