Risk Stratification Using PET in HCM

NCT ID: NCT03278457

Last Updated: 2017-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-03

Study Completion Date

2018-06-03

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.

Conditions

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Hypertrophic Cardiomyopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Positron Emission Tomography

Positron Emission Tomography

Intervention Type DIAGNOSTIC_TEST

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Landstinget i Värmland

OTHER

Sponsor Role collaborator

Dalarna County Council, Sweden

OTHER

Sponsor Role collaborator

Uppsala University Hospital

OTHER

Sponsor Role collaborator

Region Gävleborg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens Sörensen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Region Gävleborg

Locations

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Region Gavleborg

Gävle, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Peter Magnusson, MD

Role: CONTACT

+46705089407

Jonny Nordström, MSc

Role: CONTACT

+46725727670

Facility Contacts

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Peter Magnusson, M.D.

Role: primary

+46705089407

Jonny Nordström, MSc

Role: backup

+46725727670

References

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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.

Reference Type BACKGROUND
PMID: 25173338 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10952953 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20069294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12651046 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21377644 (View on PubMed)

Other Identifiers

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2017021

Identifier Type: -

Identifier Source: org_study_id

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