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Risk Stratification Using PET in HCM

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03278457
Acronym
HCM-PET
Enrollment
25
Registered
2017-09-11
Start date
2017-05-03
Completion date
2018-06-03
Last updated
2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Cardiomyopathy

Keywords

hypertrophic cardiomyopathy, implantable cardioverter defibrillator, positron emission tomography

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.

Interventions

DIAGNOSTIC_TESTPositron Emission Tomography

Positron Emission Tomography

Sponsors

Landstinget i Värmland
CollaboratorOTHER
Dalarna County Council, Sweden
CollaboratorOTHER
Uppsala University Hospital
CollaboratorOTHER
Region Gävleborg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Ventricular tachycardia (VT) vs ejection fractionHistory of VT since receiving an implantable defibrillator within last 15 yearsVentricular tachycardia vs positron emissions tomography parameter ejection fraction (EF)
Ventricular tachycardia (VT) vs myocardial blood flowHistory of VT since receiving an implantable defibrillator within last 15 yearsVentricular tachycardia vs positron emissions tomography parameter Myocardial blood flow (MBF)
Ventricular tachycardia (VT) vs massHistory of VT since receiving an implantable defibrillator within last 15 yearsVentricular tachycardia vs positron emissions tomography parameter mass
Ventricular tachycardia (VT) vs wall thicknessHistory of VT since receiving an implantable defibrillator within last 15 yearsVentricular tachycardia vs positron emissions tomography parameter wall thickness
Ventricular tachycardia (VT) vs oxygen consumptionHistory of VT since receiving an implantable defibrillator within last 15 yearsVentricular tachycardia vs positron emissions tomography parameter oxygen consumption (MVO2)
Ventricular tachycardia (VT) vs sympathetic innervationHistory of VT since receiving an implantable defibrillator within last 15 yearsVentricular tachycardia vs positron emissions tomography parameter sympathetic innervation (retention index)
Ventricular tachycardia (VT) vs myocardial external efficiencyHistory of VT since receiving an implantable defibrillator within last 15 yearsVentricular tachycardia vs positron emissions tomography parameter myocardial external efficiency (MEE)
Ventricular tachycardia (VT) vs stroke workHistory of VT since receiving an implantable defibrillator within last 15 yearsVentricular tachycardia vs positron emissions tomography parameter stroke work (SW)

Secondary

MeasureTime frameDescription
Atrial fibrillation (AF) vs myocardial blood flowHistory of VT since receiving an implantable defibrillator within last 15 yearsAtrial fibrillation vs positron emissions tomography parameter myocardial blood flow
Atrial size vs ventricular tachycardiaHistory of VT since receiving an implantable defibrillator within last 15 yearsatrial diameter, volume vs ventricular tachycardia
Atrial fibrillation (AF) vs ejection fractionHistory of VT since receiving an implantable defibrillator within last 15 yearsAtrial fibrillation vs positron emissions tomography parameter ejection fraction (EF)
Atrial fibrillation (AF) vs massHistory of VT since receiving an implantable defibrillator within last 15 yearsAtrial fibrillation vs positron emissions tomography parameter mass
Atrial fibrillation (AF) vs wall thicknessHistory of VT since receiving an implantable defibrillator within last 15 yearsAtrial fibrillation vs positron emissions tomography parameter wall thickness
Atrial fibrillation (AF) vs oxygen consumptionHistory of VT since receiving an implantable defibrillator within last 15 yearsAtrial fibrillation vs positron emissions tomography parameter oxygen consumption (MVO2)
Atrial fibrillation (AF) vs sympathetic innervationHistory of VT since receiving an implantable defibrillator within last 15 yearsAtrial fibrillation vs positron emissions tomography parameter sympathetic innervation (retention index)
Atrial fibrillation (AF) vs myocardial external efficiencyHistory of VT since receiving an implantable defibrillator within last 15 yearsAtrial fibrillation vs positron emissions tomography parameter myocardial external efficiency (MEE)
Atrial fibrillation (AF) vs stroke workHistory of VT since receiving an implantable defibrillator within last 15 yearsAtrial fibrillation vs positron emissions tomography parameter stroke work (SW)

Countries

Sweden

Contacts

Primary ContactPeter Magnusson, MD
peter.magnusson@regiongavleborg.se+46705089407
Backup ContactJonny Nordström, MSc
jonny.nordstrom@regiongavleborg.se+46725727670

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026