Risk Stratification Using PET in HCM

• Conditions: Hypertrophic Cardiomyopathy

• Registration Number: NCT03278457
• Lead Sponsor: Region Gävleborg

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-05-03
• Study First Submitted: 2017-08-21
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-07
• Last Update Submitted: 2017-09-07
• Study First Posted: 2017-09-11
• Last Update Posted: 2017-09-11
• Primary Completion: 2018-01-03
• Study Completion: 2018-06-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ventricular tachycardia (VT) vs myocardial blood flow	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	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	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	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	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	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	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	History of VT since receiving an implantable defibrillator within last 15 years	Ventricular tachycardia vs positron emissions tomography parameter stroke work (SW)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Region Gavleborg; 🇸🇪 Gävle, Sweden