Brief Title
18F-deoxyglucose (FDG) PET-CMD
Official Title
Monocentric, Prospective, Uncontrolled Pilot Study of Extra Cardiomyocytary Fixation Profile in 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography in Patients With Dilated Cardiomyopathy.
Brief Summary
18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) may have application in a
promising tool for identification of myocardial inflammation in patients with dilated
cardiomyopathy (DCM).Therefore, the purpose of the study is to confirm the hypothesis of the
fixation of FDG in non cardiomyocyte cells in a number of patients with DCM, to specify the
frequency and describe the different binding profiles in comparison with MRI data.
Patients will perform an ethologic evaluation of a non ischemic DCM with in a cardiac MRI.
All patients will have with in 4 weeks after the MRI a 18F-fluorodeoxyglucose (FDG) PET. A
high fat and low carbohydrate diet and an heparin injection will be prescribed to patients
before this FDG PET.
Patients will be identified as FDG+ or FDG -. The clinical status of the patient will be
completed by a 12 months evaluation.
Study Type
Interventional
Primary Outcome
Determine the percentage of patients with a diagnostic potential of the 18F-FDG PET in the detection of a significant non-cardiomyocyte hypermetabolism
Secondary Outcome
Comparison of clinical, biology, and left and ventricular remodeling at the time of diagnosis of DCM between the group of patients with significative myocardial no cardiomyocytaire uptake (FDG +) and those with no uptake (FDG -)
Condition
Patients With Idiopathic Dilated Cardiomyopathy
Intervention
18F-deoxyglucose (FDG)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
June 2014
Primary Completion Date
May 2018
Eligibility Criteria
Inclusion Criteria:
- Patients above 18 years of age
- Patients with DCM as defined by the European Society of Cardiology and recognized as
such by the clinician cardiologist
- DCM diagnosed for more than two weeks without new ventricular arrhythmias or
AuriculoVentricular Block (AVB) second or third degree , who responded to the usual
treatment in the first two weeks of treatment
- No family history of DCM
- Lake of clinical or biological cases for periphiral myopathy or myotonia
- Absence of other causes of non-family DCM discovered during the initial etiological (
some deficiency , toxic alcoholic or drug )
- Patients who underwent cardiac MRI for etiological DCM for less than four weeks at the
time of obtaining consent
- Patients who have read and understood the information letter and who signed the
consent form
- Affiliated to a social insurance
Exclusion Criteria:
- Ischemic cardiomyopathy defined by history of myocardial infarction or myocardial
revascularization , stenosis ≥ 75% of the core or the left coronary artery anterior
interventricular proximal stenosis ≥ 75% on at least two epicardial vessels
- Significant organic valvular echocardiography
- Eosinophilia or immuno- allergic mechanism suspected
- History of acute myocarditis
- History of sarcoidosis
- Family history of DCM
- History of chemotherapy with anthracyclines
- Patient with signs of circulatory failure or congestive heart failure requiring
intravenous positive inotropic therapy or diuretic therapy
- Treatment immunosuppressive received from cardiac MRI
- Hypersensitivity to heparin.
- History of severe thrombocytopenia type II ( heparin induced thrombocytopenia or
immuno- allergic thrombocytopenia ) , heparin or unfractionated heparin , low
molecular weight
- Other causes of non-family DCM discovered during the initial etiological ( some
deficiency , toxic alcohol or medication , endocrine )
- Patients with active neoplasia
- Patients with chronic liver disease
- Patients with connective : rheumatoid arthritis , systemic lupus erythematosus ,
systemic sclerosis , dermato- polymyositis , mixed connective
- Patients with Crohn's disease
- Patients with active tuberculosis
- Pregnant or lactating women
- Minors
- Major Trust
- No affiliation to a social insurance
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Nicolas Piriou, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02078141
Organization ID
RC14_0002
Responsible Party
Sponsor
Study Sponsor
Nantes University Hospital
Study Sponsor
Nicolas Piriou, MD, Principal Investigator, Nantes UH
Verification Date
March 2018