18F-deoxyglucose (FDG) PET-CMD

NCT02078141 | Completed

• 1 other identifier: RC14_0002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Keywords

18F-deoxyglucose (FDG) PET, idiopathic Dilated Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Determine the percentage of patients with a diagnostic potential of the 18F-FDG PET in the detection of a significant non-cardiomyocyte hypermetabolism

  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.

  12 months

Secondary Outcomes (4)

• 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 MRI

  12 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 results

  12 months

Study Arms (1)

18F-deoxyglucose (FDG)

EXPERIMENTAL

18F-deoxyglucose (FDG)

Drug: 18F-deoxyglucose (FDG)

Interventions

18F-deoxyglucose (FDG) 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

18F-deoxyglucose (FDG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (2)

Nantes UH

Nantes, 44903, France

Location

West Cancerology Institute/Nantes UH : PET plateform

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Nicolas Piriou, MD

  Nantes UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: March 5, 2014
• Study Start: June 24, 2014
• Primary Completion: January 18, 2018
• Study Completion: January 18, 2018
• Last Updated: July 26, 2022

Record last verified: 2022-07

Locations

FR (2)