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?

Terminated

• Conditions: Defibrillators, Implantable

• 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

Study Timeline

• Study First Submitted: 2010-12-09
• Study First Submitted QC: 2010-12-09
• Study First Posted: 2010-12-10
• Study Start: 2011-06
• Primary Completion: 2015-08
• Status Verified: 2015-10
• Study Completion: 2016-06
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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.

Trial Locations

Locations (2)

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes, Gard, France

Centre Hospitalier Universitaire de Montpellier; 🇫🇷 Montpellier, France