18F-deoxyglucose (FDG) PET-CMD

NCT ID: NCT02078141

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-24
• Study Completion Date: 2018-01-18

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.

Conditions

Patients With Idiopathic Dilated Cardiomyopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-deoxyglucose (FDG)

18F-deoxyglucose (FDG)

Group Type: EXPERIMENTAL

18F-deoxyglucose (FDG)

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Piriou, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes UH

Locations

Nantes UH

Nantes, , France

West Cancerology Institute/Nantes UH : PET plateform

Saint-Herblain, , France

Countries

France

Other Identifiers

RC14_0002

Identifier Type: -

Identifier Source: org_study_id