Risk Stratification Using PET in HCM

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypertrophic Cardiomyopathy

Intervention / Treatment
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* Diagnostic Test: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hypertrophic cardiomyopathy, implantable cardioverter defibrillator, informed consent Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Positron Emission Tomography|Positron Emission Tomography|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular tachycardia (VT) vs myocardial blood flow | Ventricular tachycardia vs positron emissions tomography parameter Myocardial blood flow (MBF) | History of VT since receiving an implantable defibrillator within last 15 years | 
| Ventricular tachycardia (VT) vs ejection fraction | Ventricular tachycardia vs positron emissions tomography parameter ejection fraction (EF) | History of VT since receiving an implantable defibrillator within last 15 years | 
| Ventricular tachycardia (VT) vs mass | Ventricular tachycardia vs positron emissions tomography parameter mass | History of VT since receiving an implantable defibrillator within last 15 years | 
| Ventricular tachycardia (VT) vs wall thickness | Ventricular tachycardia vs positron emissions tomography parameter wall thickness | History of VT since receiving an implantable defibrillator within last 15 years | 
| Ventricular tachycardia (VT) vs oxygen consumption | Ventricular tachycardia vs positron emissions tomography parameter oxygen consumption (MVO2) | History of VT since receiving an implantable defibrillator within last 15 years | 
| Ventricular tachycardia (VT) vs sympathetic innervation | Ventricular tachycardia vs positron emissions tomography parameter sympathetic innervation (retention index) | History of VT since receiving an implantable defibrillator within last 15 years | 
| Ventricular tachycardia (VT) vs myocardial external efficiency | Ventricular tachycardia vs positron emissions tomography parameter myocardial external efficiency (MEE) | History of VT since receiving an implantable defibrillator within last 15 years | 
| Ventricular tachycardia (VT) vs stroke work | Ventricular tachycardia vs positron emissions tomography parameter stroke work (SW) | History of VT since receiving an implantable defibrillator within last 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation (AF) vs myocardial blood flow | Atrial fibrillation vs positron emissions tomography parameter myocardial blood flow | History of VT since receiving an implantable defibrillator within last 15 years | 
| Atrial fibrillation (AF) vs ejection fraction | Atrial fibrillation vs positron emissions tomography parameter ejection fraction (EF) | History of VT since receiving an implantable defibrillator within last 15 years | 
| Atrial fibrillation (AF) vs mass | Atrial fibrillation vs positron emissions tomography parameter mass | History of VT since receiving an implantable defibrillator within last 15 years | 
| Atrial fibrillation (AF) vs wall thickness | Atrial fibrillation vs positron emissions tomography parameter wall thickness | History of VT since receiving an implantable defibrillator within last 15 years | 
| Atrial fibrillation (AF) vs oxygen consumption | Atrial fibrillation vs positron emissions tomography parameter oxygen consumption (MVO2) | History of VT since receiving an implantable defibrillator within last 15 years | 
| Atrial fibrillation (AF) vs sympathetic innervation | Atrial fibrillation vs positron emissions tomography parameter sympathetic innervation (retention index) | History of VT since receiving an implantable defibrillator within last 15 years | 
| Atrial fibrillation (AF) vs myocardial external efficiency | Atrial fibrillation vs positron emissions tomography parameter myocardial external efficiency (MEE) | History of VT since receiving an implantable defibrillator within last 15 years | 
| Atrial fibrillation (AF) vs stroke work | Atrial fibrillation vs positron emissions tomography parameter stroke work (SW) | History of VT since receiving an implantable defibrillator within last 15 years | 
| Atrial size vs ventricular tachycardia | atrial diameter, volume vs ventricular tachycardia | History of VT since receiving an implantable defibrillator within last 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertrophic cardiomyopathy, implantable cardioverter defibrillator, positron emission tomography