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?
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|ClinicalTrials.gov Identifier: NCT01258283|
Recruitment Status : Terminated (Inclusion rate too slow / infeasible.)
First Posted : December 10, 2010
Last Update Posted : February 3, 2017
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.
|Condition or disease||Intervention/treatment|
|Defibrillators, Implantable||Other: Addional imaging|
|Study Type :||Observational|
|Actual Enrollment :||6 participants|
|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?|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||June 2016|
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
- Presence/absence of a triggering of the defibrillator within 3 years of follow up [ Time Frame: 3 years ]The primary endpoint is the triggering of the defibrillator within 3 years of follow up. Mismatch segments will be studied as predictors of arrhythmia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|