PET / CT With 18F-FDG: Does it Optimize the I 123-MIBG Imaging Results in the Search for Discriminating Factors for the Implementation of an Implantable Defibrillator?
The main objective of this study is to determine among the patients included a subpopulation that does not need a defibrillator.
This will be done by comparing the number of discordant segments (mismatch) between patients who have a severe arrhythmia (ventricular tachycardia or ventricular fibrillation) with appropriate electrical therapy within 3 years of monitoring and others. "Mismatch" in the definition of this objective is the usual definition: score 3.4 in I123-MIBG (Iodine 123 metaiodobenzylguanidine) and PET at 0,1,2.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||PET / CT With 18F-FDG (18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography): Does it Optimize the I 123-MIBG (Iodine 123 Metaiodobenzylguanidine) Imaging Results in the Search for Discriminating Factors for the Implementation of an Implantable Defibrillator for Primary Prevention in Patients With Heart Failure of Ischemic Origin?|
- Presence/absence of a triggering of the defibrillator within 3 years of follow up [ Time Frame: 3 years ] [ Designated as safety issue: No ]The primary endpoint is the triggering of the defibrillator within 3 years of follow up. Mismatch segments will be studied as predictors of arrhythmia.
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
The study population
See inclusion and exclusion criteria.
Other: Addional imaging
All patients will systematically have an 18F-FDG PET-CT (18F-fluorodeoxyglucose positron emission tomography/computed tomography) and a 123MIBG (Iodine 123 metaiodobenzylguanidine) scintigraphy
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258283
|Centre Hospitalier Universitaire de Nîmes|
|Nîmes, Gard, France, 30029|
|Centre Hospitalier Universitaire de Montpellier|
|Principal Investigator:||Vincent Boudousq, MD||Centre Hospitalier Universitaire de Nîmes|