18F-deoxyglucose (FDG) PET-CMD

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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