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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?

C

Centre Hospitalier Universitaire de Nīmes

Status

Terminated

Conditions

Defibrillators, Implantable

Treatments

Other: Addional imaging

Study type

Observational

Funder types

Other

Identifiers

NCT01258283
2008-007163-16 (Other Identifier)
PHRC-I/2008/VB-03

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No 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)

Trial design

6 participants in 1 patient group

The study population
Description:
See inclusion and exclusion criteria.
Treatment:
Other: Addional imaging

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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