UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006533
Receipt No. 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

* 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 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
Email

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
Email kyoshi@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Graduate School of Medicine,
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007744

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.