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?

Defibrillators, Implantable Clinical Trial

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?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01258283
• Other study ID #: PHRC-I/2008/VB-03
• Secondary ID: 2008-007163-16
• Status: Terminated
• Phase: N/A
• First received: December 9, 2010
• Last updated: February 2, 2017
• Start date: June 2011
• Est. completion date: June 2016

Study information

• Verified date: October 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Defibrillators, Implantable

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Montpellier	Montpellier
France	Centre Hospitalier Universitaire de Nîmes	Nîmes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence/absence of a triggering of the defibrillator within 3 years of follow up	The primary endpoint is the triggering of the defibrillator within 3 years of follow up. Mismatch segments will be studied as predictors of arrhythmia.	3 years