Clinical trial NCT01258283: 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?
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Defibrillators, Implantable
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-12-10
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Coronary patients that should benefit from ICD (Implanted Cardiac Defibrillator) implantation for primary prevention according to current recommendations, that is to say with LVEF (left ventricular ejection fraction) \<30% in NYHA (New York Heart Association) stage II or III and within one month of an myocardial infarction or within 3 months of a complete revascularization.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Presence/absence of a triggering of the defibrillator within 3 years of follow up
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Vincent Boudousq, MD
role: PRINCIPAL_INVESTIGATOR
References: