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临床试验/NCT03278457
NCT03278457Unknown不适用

Risk Stratification Using Positron Emission Tomography (PET) in Hypertrophic Cardiomyopathy (HCM)

Region Gävleborg1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年5月3日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
1
主要终点
Ventricular tachycardia (VT) vs myocardial blood flow

研究概览

简要总结

The overall rationale is to reduce the risk of sudden cardiac death in individuals with hypertrophic cardiomyopathy (HCM). The novel approach of this study is to correlate Positron Emission Tomography (PET) findings to ventricular arrhythmias detected by the implantable cardioverter defibrillator (ICD). This could potentially lead to an improved risk stratification of HCM patients.

详细描述

Positron Emission Tomography (PET) is a functional imaging technique that utilizes radioactive tracers to gain information on physiological or pathophysiological processes in vivo. Different tracers can provide information on different processes of interest. In cardiology, metabolic processes consuming oxygen (aerobic) can be studied with 11-Carbon-Acetate, sympathetic innervation can be studied with 11-Carbon-hydroxyephedrine and using 15-Oxygen-water the myocardial blood flow. Structural information of the heart such as left ventricular mass, left ventricular volumes and wall thickness can also be calculated with PET.

The aim is to correlate PET parameters and burden of ventricular arrhythmias in order to improve risk stratification in HCM.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hypertrophic cardiomyopathy, implantable cardioverter defibrillator, informed consent

排除标准

  • Patients younger than 18 years, pregnancy, breast feeding, claustrophobia, intolerance/allergic reaction to adenosin or mannitol, severe hypotension, unstable angina pectoris, incompensated systolic heart failure, increased intracranial pressure, hypovolemia, dipyramidole.

结局指标

主要结局

Ventricular tachycardia (VT) vs myocardial blood flow

时间窗: History of VT since receiving an implantable defibrillator within last 15 years

Ventricular tachycardia vs positron emissions tomography parameter Myocardial blood flow (MBF)

Ventricular tachycardia (VT) vs ejection fraction

时间窗: History of VT since receiving an implantable defibrillator within last 15 years

Ventricular tachycardia vs positron emissions tomography parameter ejection fraction (EF)

Ventricular tachycardia (VT) vs mass

时间窗: History of VT since receiving an implantable defibrillator within last 15 years

Ventricular tachycardia vs positron emissions tomography parameter mass

Ventricular tachycardia (VT) vs wall thickness

时间窗: History of VT since receiving an implantable defibrillator within last 15 years

Ventricular tachycardia vs positron emissions tomography parameter wall thickness

Ventricular tachycardia (VT) vs oxygen consumption

时间窗: History of VT since receiving an implantable defibrillator within last 15 years

Ventricular tachycardia vs positron emissions tomography parameter oxygen consumption (MVO2)

Ventricular tachycardia (VT) vs sympathetic innervation

时间窗: History of VT since receiving an implantable defibrillator within last 15 years

Ventricular tachycardia vs positron emissions tomography parameter sympathetic innervation (retention index)

Ventricular tachycardia (VT) vs myocardial external efficiency

时间窗: History of VT since receiving an implantable defibrillator within last 15 years

Ventricular tachycardia vs positron emissions tomography parameter myocardial external efficiency (MEE)

Ventricular tachycardia (VT) vs stroke work

时间窗: History of VT since receiving an implantable defibrillator within last 15 years

Ventricular tachycardia vs positron emissions tomography parameter stroke work (SW)

次要结局

  • Atrial fibrillation (AF) vs myocardial blood flow(History of VT since receiving an implantable defibrillator within last 15 years)
  • Atrial fibrillation (AF) vs ejection fraction(History of VT since receiving an implantable defibrillator within last 15 years)
  • Atrial fibrillation (AF) vs mass(History of VT since receiving an implantable defibrillator within last 15 years)
  • Atrial fibrillation (AF) vs wall thickness(History of VT since receiving an implantable defibrillator within last 15 years)
  • Atrial fibrillation (AF) vs oxygen consumption(History of VT since receiving an implantable defibrillator within last 15 years)
  • Atrial fibrillation (AF) vs sympathetic innervation(History of VT since receiving an implantable defibrillator within last 15 years)
  • Atrial fibrillation (AF) vs myocardial external efficiency(History of VT since receiving an implantable defibrillator within last 15 years)
  • Atrial fibrillation (AF) vs stroke work(History of VT since receiving an implantable defibrillator within last 15 years)
  • Atrial size vs ventricular tachycardia(History of VT since receiving an implantable defibrillator within last 15 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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