18F-deoxyglucose (FDG) PET-CMD

July 22, 2022 updated by: Nantes University Hospital

Monocentric, Prospective, Uncontrolled Pilot Study of Extra Cardiomyocytary Fixation Profile in 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography in Patients With Dilated Cardiomyopathy.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44903
        • Nantes UH
      • Saint Herblain, France, 44805
        • West Cancerology Institute/Nantes UH : PET plateform

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-deoxyglucose (FDG)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: 12 months
12 months
Describe the different profile of FDG fixation within the group of patients FDG +
Time Frame: 12 months
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
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Nicolas Piriou, MD, Nantes UH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2014

Primary Completion (Actual)

January 18, 2018

Study Completion (Actual)

January 18, 2018

Study Registration Dates

First Submitted

February 21, 2014

First Submitted That Met QC Criteria

March 3, 2014

First Posted (Estimate)

March 5, 2014

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC14_0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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