Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-25 @ 4:18 PM
Study NCT ID:
NCT03278457
Status:
UNKNOWN
Last Update Posted:
2017-09-11
First Post:
2017-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Risk Stratification Using PET in HCM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D049268', 'term': 'Positron-Emission Tomography'}], 'ancestors': [{'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-06-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-07', 'studyFirstSubmitDate': '2017-08-21', 'studyFirstSubmitQcDate': '2017-09-07', 'lastUpdatePostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventricular tachycardia (VT) vs myocardial blood flow', 'timeFrame': 'History of VT since receiving an implantable defibrillator within last 15 years', 'description': 'Ventricular tachycardia vs positron emissions tomography parameter Myocardial blood flow (MBF)'}, {'measure': 'Ventricular tachycardia (VT) vs ejection fraction', 'timeFrame': 'History of VT since receiving an implantable defibrillator within last 15 years', 'description': 'Ventricular tachycardia vs positron emissions tomography parameter ejection fraction (EF)'}, {'measure': 'Ventricular tachycardia (VT) vs mass', 'timeFrame': 'History of VT since receiving an implantable defibrillator within last 15 years', 'description': 'Ventricular tachycardia vs positron emissions tomography parameter mass'}, {'measure': 'Ventricular tachycardia (VT) vs wall thickness', 'timeFrame': 'History of VT since receiving an implantable defibrillator within last 15 years', 'description': 'Ventricular tachycardia vs positron emissions tomography parameter wall thickness'}, {'measure': 'Ventricular tachycardia (VT) vs oxygen consumption', 'timeFrame': 'History of VT since receiving an implantable defibrillator within last 15 years', 'description': 'Ventricular tachycardia vs positron emissions tomography parameter oxygen consumption (MVO2)'}, {'measure': 'Ventricular tachycardia (VT) vs sympathetic innervation', 'timeFrame': 'History of VT since receiving an implantable defibrillator within last 15 years', 'description': 'Ventricular tachycardia vs positron emissions tomography parameter sympathetic innervation (retention index)'}, {'measure': 'Ventricular tachycardia (VT) vs myocardial external efficiency', 'timeFrame': 'History of VT since receiving an implantable defibrillator within last 15 years', 'description': 'Ventricular tachycardia vs positron emissions tomography parameter myocardial external efficiency (MEE)'}, {'measure': 'Ventricular tachycardia (VT) vs stroke work', 'timeFrame': 'History of VT since receiving an implantable defibrillator within last 15 years', 'description': 'Ventricular tachycardia vs positron emissions tomography parameter stroke work (SW)'}], 'secondaryOutcomes': [{'measure': 'Atrial fibrillation (AF) vs myocardial blood flow', 'timeFrame': 'History of VT since receiving an implantable defibrillator within last 15 years', 'description': 'Atrial fibrillation vs positron emissions tomography parameter myocardial blood flow'}, {'measure': 'Atrial fibrillation (AF) vs ejection fraction', 'timeFrame': 'History of VT since receiving an implantable defibrillator within last 15 years', 'description': 'Atrial fibrillation vs positron emissions tomography parameter ejection fraction (EF)'}, {'measure': 'Atrial fibrillation (AF) vs mass', 'timeFrame': 'History of VT since receiving an implantable defibrillator within last 15 years', 'description': 'Atrial fibrillation vs positron emissions tomography parameter mass'}, {'measure': 'Atrial fibrillation (AF) vs wall thickness', 'timeFrame': 'History of VT since receiving an implantable defibrillator within last 15 years', 'description': 'Atrial fibrillation vs positron emissions tomography parameter wall thickness'}, {'measure': 'Atrial fibrillation (AF) vs oxygen consumption', 'timeFrame': 'History of VT since receiving an implantable defibrillator within last 15 years', 'description': 'Atrial fibrillation vs positron emissions tomography parameter oxygen consumption (MVO2)'}, {'measure': 'Atrial fibrillation (AF) vs sympathetic innervation', 'timeFrame': 'History of VT since receiving an implantable defibrillator within last 15 years', 'description': 'Atrial fibrillation vs positron emissions tomography parameter sympathetic innervation (retention index)'}, {'measure': 'Atrial fibrillation (AF) vs myocardial external efficiency', 'timeFrame': 'History of VT since receiving an implantable defibrillator within last 15 years', 'description': 'Atrial fibrillation vs positron emissions tomography parameter myocardial external efficiency (MEE)'}, {'measure': 'Atrial fibrillation (AF) vs stroke work', 'timeFrame': 'History of VT since receiving an implantable defibrillator within last 15 years', 'description': 'Atrial fibrillation vs positron emissions tomography parameter stroke work (SW)'}, {'measure': 'Atrial size vs ventricular tachycardia', 'timeFrame': 'History of VT since receiving an implantable defibrillator within last 15 years', 'description': 'atrial diameter, volume vs ventricular tachycardia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertrophic cardiomyopathy', 'implantable cardioverter defibrillator', 'positron emission tomography'], 'conditions': ['Hypertrophic Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '25173338', 'type': 'BACKGROUND', 'citation': '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': '10952953', 'type': 'BACKGROUND', 'citation': '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': '20069294', 'type': 'BACKGROUND', 'citation': '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': '12651046', 'type': 'BACKGROUND', 'citation': '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': '21377644', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe aim is to correlate PET parameters and burden of ventricular arrhythmias in order to improve risk stratification in HCM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hypertrophic cardiomyopathy (HCM) and an implantable defibrillator (ICD)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypertrophic cardiomyopathy, implantable cardioverter defibrillator, informed consent\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT03278457', 'acronym': 'HCM-PET', 'briefTitle': 'Risk Stratification Using PET in HCM', 'organization': {'class': 'OTHER', 'fullName': 'Region Gävleborg'}, 'officialTitle': 'Risk Stratification Using Positron Emission Tomography (PET) in Hypertrophic Cardiomyopathy (HCM)', 'orgStudyIdInfo': {'id': '2017021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Positron Emission Tomography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Positron Emission Tomography'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80324', 'city': 'Gävle', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Peter Magnusson, M.D.', 'role': 'CONTACT', 'email': 'peter.magnusson@regiongavleborg.se', 'phone': '+46705089407'}, {'name': 'Jonny Nordström, MSc', 'role': 'CONTACT', 'email': 'jonny.nordstrom@regiongavleborg.se', 'phone': '+46725727670'}], 'facility': 'Region Gavleborg', 'geoPoint': {'lat': 60.67452, 'lon': 17.14174}}], 'centralContacts': [{'name': 'Peter Magnusson, MD', 'role': 'CONTACT', 'email': 'peter.magnusson@regiongavleborg.se', 'phone': '+46705089407'}, {'name': 'Jonny Nordström, MSc', 'role': 'CONTACT', 'email': 'jonny.nordstrom@regiongavleborg.se', 'phone': '+46725727670'}], 'overallOfficials': [{'name': 'Jens Sörensen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Region Gävleborg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Gävleborg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Landstinget i Värmland', 'class': 'OTHER'}, {'name': 'Dalarna County Council, Sweden', 'class': 'OTHER'}, {'name': 'Uppsala University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}