Back to results18F-deoxyglucose (FDG) PET-CMD
Primary Purpose
Patients With Idiopathic Dilated Cardiomyopathy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
18F-deoxyglucose (FDG)
Sponsored by
About this trial
This is an interventional diagnostic trial for Patients With Idiopathic Dilated Cardiomyopathy focused on measuring 18F-deoxyglucose (FDG) PET, idiopathic Dilated Cardiomyopathy
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
Sites / Locations
- Nantes UH
- West Cancerology Institute/Nantes UH : PET plateform
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-deoxyglucose (FDG)
Arm Description
18F-deoxyglucose (FDG)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 -)
Evaluate the performance of 18F-FDG PET for the detection of myocardial inflammation in the initial evaluation of DCM patients compared to cardiac MRI
Describe the different profile of FDG fixation within the group of patients FDG +
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
Full Information
NCT ID
NCT02078141
First Posted
February 21, 2014
Last Updated
July 22, 2022
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02078141
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 24, 2014 (Actual)
Primary Completion Date
January 18, 2018 (Actual)
Study Completion Date
January 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Idiopathic Dilated Cardiomyopathy
Keywords
18F-deoxyglucose (FDG) PET, idiopathic Dilated Cardiomyopathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
18F-deoxyglucose (FDG)
Arm Type
Experimental
Arm Description
18F-deoxyglucose (FDG)
Intervention Type
Drug
Intervention Name(s)
18F-deoxyglucose (FDG)
Intervention Description
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 Measure Information:
Title
Determine the percentage of patients with a diagnostic potential of the 18F-FDG PET in the detection of a significant non-cardiomyocyte hypermetabolism
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Describe the different profile of FDG fixation within the group of patients FDG +
Time Frame
12 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Piriou, MD
Organizational Affiliation
Nantes UH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes UH
City
Nantes
ZIP/Postal Code
44903
Country
France
Facility Name
West Cancerology Institute/Nantes UH : PET plateform
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
12. IPD Sharing Statement
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18F-deoxyglucose (FDG) PET-CMD
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