Risk Stratification Using PET in HCM

NCT03278457 | Unknown

• 1 other identifier: 2017021
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Cardiomyopathy

Keywords

hypertrophic cardiomyopathy; implantable cardioverter defibrillator; positron emission tomography

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (9)

• 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

Interventions

Positron Emission Tomography DIAGNOSTIC_TEST

Positron Emission Tomography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Hypertrophic cardiomyopathy, implantable cardioverter defibrillator, informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Gävleborg: lead
• Landstinget i Värmland: collaborator
• Dalarna County Council, Sweden: collaborator
• Uppsala University Hospital: collaborator

Study Sites (1)

Region Gavleborg

Gävle, 80324, Sweden

RECRUITING

Related Publications (5)

• 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.

  PMID: 25173338 BACKGROUND

• 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.

  PMID: 10952953 BACKGROUND

• 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.

  PMID: 20069294 BACKGROUND

• 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.

  PMID: 12651046 BACKGROUND

• 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.

  PMID: 21377644 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Jens Sörensen, MD PhD

  Region Gävleborg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Magnusson, MD

CONTACT

+46705089407; peter.magnusson@regiongavleborg.se

Jonny Nordström, MSc

CONTACT

+46725727670; jonny.nordstrom@regiongavleborg.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: September 11, 2017
• Study Start: May 3, 2017
• Primary Completion: January 3, 2018
• Study Completion: June 3, 2018
• Last Updated: September 11, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)