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18F-deoxyglucose (FDG) PET-CMD

Not Applicable
Completed
Conditions
Patients With Idiopathic Dilated Cardiomyopathy
Interventions
Drug: 18F-deoxyglucose (FDG)
Registration Number
NCT02078141
Lead Sponsor
Nantes University Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
18F-deoxyglucose (FDG)18F-deoxyglucose (FDG)18F-deoxyglucose (FDG)
Primary Outcome Measures
NameTimeMethod
Determine the percentage of patients with a diagnostic potential of the 18F-FDG PET in the detection of a significant non-cardiomyocyte hypermetabolism12 months

We want to objective a significant hypermetabolic extra-cardiomyocyte by 18F-FDG PET examination, in favor of myocardial inflammation in patients with DCM diagnosed for more than two weeks without new ventricular arrhythmias or second AVB or third degree, and who responded to the usual treatment in the first two weeks of treatment.

Secondary Outcome Measures
NameTimeMethod
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 -)12 months
Evaluate the performance of 18F-FDG PET for the detection of myocardial inflammation in the initial evaluation of DCM patients compared to cardiac MRI12 months
Describe the different profile of FDG fixation within the group of patients FDG +12 months
impact of the presence or absence of a non-cardiomyocyte uptake of 18F-FDG PET at diagnosis of DCM in regard to the clinical status, ultrasound and MRI results12 months

Trial Locations

Locations (2)

Nantes UH

🇫🇷

Nantes, France

West Cancerology Institute/Nantes UH : PET plateform

🇫🇷

Saint Herblain, France

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