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?
- Conditions
- Defibrillators, Implantable
- Interventions
- Other: Addional imaging
- Registration Number
- NCT01258283
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
- Patient with ischemic heart disease with heart failure
- Patients who received myocardial perfusion scintigraphy
- Indication for the implantation of an ICD installed according to current recommendations : LVEF <30% and NYHA (New York Heart Association) stage II, III.
- The subject must have given his informed consent and signed consent
- The subject must be a member or beneficiary of a social security system
- Pregnant or lactating women
- History of "open heart" cardiovascular surgery
- Inability to sign informed consent (patient under guardianship)
- Patients with diabetes mellitus
- Patient with proven dementia
- Person refusing to sign the consent
- Someone who already has an ICD at baseline
- Life expectancy less than one year (NYHA IV, other diseases such as neoplastic disease in an advanced stage)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description The study population Addional imaging See inclusion and exclusion criteria.
- Primary Outcome Measures
Name Time Method Presence/absence of a triggering of the defibrillator within 3 years of follow up 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Centre Hospitalier Universitaire de Nîmes
🇫🇷Nîmes, Gard, France
Centre Hospitalier Universitaire de Montpellier
🇫🇷Montpellier, France