Risk Stratification Using PET in HCM (HCM-PET)

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertrophic Cardiomyopathy
• Intervention / Treatment: Diagnostic test: Positron Emission Tomography

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 Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: Peter Magnusson, MD; Phone Number: +46705089407; Email: peter.magnusson@regiongavleborg.se
• Study Contact Backup: Name: Jonny Nordström, MSc; Phone Number: +46725727670; Email: jonny.nordstrom@regiongavleborg.se

Study Locations

• Sweden
  • Gävle, Sweden, 80324
    • Recruiting
    • Region Gävleborg
    • Contact: Peter Magnusson, M.D.; Phone Number: +46705089407; Email: peter.magnusson@regiongavleborg.se
    • Contact: Jonny Nordström, MSc; Phone Number: +46725727670; Email: jonny.nordstrom@regiongavleborg.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with hypertrophic cardiomyopathy (HCM) and an implantable defibrillator (ICD)

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Region Gävleborg
• Collaborators: Dalarna County Council, Sweden; Uppsala University Hospital; Landstinget i Värmland
• Investigators: Principal Investigator: Jens Sörensen, MD PhD, Region Gävleborg

Publications and helpful links

General Publications

• Authors/Task Force members; Elliott PM, Anastasakis A, Borger MA, Borggrefe M, Cecchi F, Charron P, Hagege AA, Lafont A, Limongelli G, Mahrholdt H, McKenna WJ, Mogensen J, Nihoyannopoulos P, Nistri S, Pieper PG, Pieske B, Rapezzi C, Rutten FH, Tillmanns C, Watkins H. 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy: the Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society of Cardiology (ESC). Eur Heart J. 2014 Oct 14;35(39):2733-79. doi: 10.1093/eurheartj/ehu284. Epub 2014 Aug 29. No abstract available.
• Maron BJ, Olivotto I, Spirito P, Casey SA, Bellone P, Gohman TE, Graham KJ, Burton DA, Cecchi F. Epidemiology of hypertrophic cardiomyopathy-related death: revisited in a large non-referral-based patient population. Circulation. 2000 Aug 22;102(8):858-64. doi: 10.1161/01.cir.102.8.858.
• Kofflard MJ, Ten Cate FJ, van der Lee C, van Domburg RT. Hypertrophic cardiomyopathy in a large community-based population: clinical outcome and identification of risk factors for sudden cardiac death and clinical deterioration. J Am Coll Cardiol. 2003 Mar 19;41(6):987-93. doi: 10.1016/s0735-1097(02)03004-8.
• Timmer SA, Germans T, Gotte MJ, Russel IK, Dijkmans PA, Lubberink M, ten Berg JM, ten Cate FJ, Lammertsma AA, Knaapen P, van Rossum AC. Determinants of myocardial energetics and efficiency in symptomatic hypertrophic cardiomyopathy. Eur J Nucl Med Mol Imaging. 2010 Apr;37(4):779-88. doi: 10.1007/s00259-009-1350-3. Epub 2010 Jan 13.
• Timmer SA, Germans T, Gotte MJ, Russel IK, Lubberink M, Ten Berg JM, Ten Cate FJ, Lammertsma AA, Knaapen P, van Rossum AC. Relation of coronary microvascular dysfunction in hypertrophic cardiomyopathy to contractile dysfunction independent from myocardial injury. Am J Cardiol. 2011 May 15;107(10):1522-8. doi: 10.1016/j.amjcard.2011.01.029. Epub 2011 Mar 4.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2017
• Primary Completion (Anticipated): January 3, 2018
• Study Completion (Anticipated): June 3, 2018

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (Actual): September 11, 2017

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: positron emission tomography; implantable cardioverter defibrillator; hypertrophic cardiomyopathy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: 2017021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No