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Clinical Trials/NCT01258283
NCT01258283
Terminated
Not Applicable

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?

Centre Hospitalier Universitaire de Nīmes2 sites in 1 country6 target enrollmentJune 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Defibrillators, Implantable
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
6
Locations
2
Primary Endpoint
Presence/absence of a triggering of the defibrillator within 3 years of follow up
Status
Terminated
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
June 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Presence/absence of a triggering of the defibrillator within 3 years of follow up

Time Frame: 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.

Study Sites (2)

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