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Trial record 8 of 157 for:    Idiopathic Dilated Cardiomyopathy

18F-deoxyglucose (FDG) PET-CMD

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ClinicalTrials.gov Identifier: NCT02078141
Recruitment Status : Active, not recruiting
First Posted : March 5, 2014
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Patients With Idiopathic Dilated Cardiomyopathy Drug: 18F-deoxyglucose (FDG) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Monocentric, Prospective, Uncontrolled Pilot Study of Extra Cardiomyocytary Fixation Profile in 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography in Patients With Dilated Cardiomyopathy.
Study Start Date : June 2014
Estimated Primary Completion Date : May 2018



Intervention Details:
  • Drug: 18F-deoxyglucose (FDG)
    18F-deoxyglucose (FDG) One injection of 3.5 MBq/kg of 18FDG with a minimum of 220 MBq and a maximum of 400 MBq


Primary Outcome Measures :
  1. Determine the percentage of patients with a diagnostic potential of the 18F-FDG PET in the detection of a significant non-cardiomyocyte hypermetabolism [ Time Frame: 12 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 :
  1. 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 -) [ Time Frame: 12 months ]
  2. Evaluate the performance of 18F-FDG PET for the detection of myocardial inflammation in the initial evaluation of DCM patients compared to cardiac MRI [ Time Frame: 12 months ]
  3. Describe the different profile of FDG fixation within the group of patients FDG + [ Time Frame: 12 months ]
  4. 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 results [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078141


Locations
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France
Nantes UH
Nantes, France, 44903
West Cancerology Institute/Nantes UH : PET plateform
Saint Herblain, France, 44805
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Nicolas Piriou, MD Nantes UH

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02078141     History of Changes
Other Study ID Numbers: RC14_0002
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Keywords provided by Nantes University Hospital:
18F-deoxyglucose (FDG) PET, idiopathic Dilated Cardiomyopathy
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly
Deoxyglucose
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents