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?

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?

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01258283

Enrollment

Registered

2010-12-10

Start date

2011-06-30

Completion date

2016-06-30

Last updated

2017-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Defibrillators, Implantable

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.

Interventions

OTHERAddional 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026