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?
Verified date | October 2015 |
Source | Centre Hospitalier Universitaire de Nimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Universitaire de Montpellier | Montpellier | |
France | Centre Hospitalier Universitaire de Nîmes | Nîmes | Gard |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
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 |
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