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?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Presence/absence of a triggering of the defibrillator within 3 years of follow up
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Presence/absence of a triggering of the defibrillator within 3 years of follow up
时间窗: 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.
次要结局
未报告次要终点