Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-26 @ 4:55 PM
Study NCT ID:
NCT00916435
Status:
COMPLETED
Last Update Posted:
2015-04-21
First Post:
2009-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Implantable Cardioverter Defibrillator (ICD) Intracardiac Electrograms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 630}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-19', 'studyFirstSubmitDate': '2009-06-08', 'studyFirstSubmitQcDate': '2009-06-08', 'lastUpdatePostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sustained ventricular tachycardia with appropriate ICD therapies (either shock or ATP)', 'timeFrame': 'from enrollment up to 72 months'}], 'secondaryOutcomes': [{'measure': 'Composite heart failure outcome (HF hospitalization, HF death, heart transplant)', 'timeFrame': 'from enrollment up to 72 months'}, {'measure': 'All-cause mortality', 'timeFrame': 'from enrollment up to 72 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arrhythmia', 'Cardiac Arrest', 'Cardiomyopathy', 'Heart Failure'], 'conditions': ['Congestive Heart Failure', 'Sudden Cardiac Death', 'Arrhythmia', 'Cardiomyopathies']}, 'referencesModule': {'references': [{'pmid': '19808478', 'type': 'RESULT', 'citation': 'Tereshchenko LG, Fetics BJ, Domitrovich PP, Lindsay BD, Berger RD. Prediction of ventricular tachyarrhythmias by intracardiac repolarization variability analysis. Circ Arrhythm Electrophysiol. 2009 Jun;2(3):276-84. doi: 10.1161/CIRCEP.108.829440. Epub 2009 Mar 6.'}, {'pmid': '19700170', 'type': 'RESULT', 'citation': 'Tereshchenko LG, Fetics BJ, Berger RD. Intracardiac QT variability in patients with structural heart disease on class III antiarrhythmic drugs. J Electrocardiol. 2009 Nov-Dec;42(6):505-10. doi: 10.1016/j.jelectrocard.2009.07.011. Epub 2009 Aug 22.'}, {'pmid': '19695461', 'type': 'RESULT', 'citation': 'Tereshchenko LG, Faddis MN, Fetics BJ, Zelik KE, Efimov IR, Berger RD. Transient local injury current in right ventricular electrogram after implantable cardioverter-defibrillator shock predicts heart failure progression. J Am Coll Cardiol. 2009 Aug 25;54(9):822-8. doi: 10.1016/j.jacc.2009.06.004.'}, {'pmid': '21087331', 'type': 'RESULT', 'citation': 'Stempniewicz P, Cheng A, Connolly A, Wang XY, Calkins H, Tomaselli GF, Berger RD, Tereshchenko LG. Appropriate and inappropriate electrical therapies delivered by an implantable cardioverter-defibrillator: effect on intracardiac electrogram. J Cardiovasc Electrophysiol. 2011 May;22(5):554-60. doi: 10.1111/j.1540-8167.2010.01958.x. Epub 2010 Nov 18.'}, {'pmid': '21699842', 'type': 'RESULT', 'citation': 'Oosterhoff P, Tereshchenko LG, van der Heyden MA, Ghanem RN, Fetics BJ, Berger RD, Vos MA. Short-term variability of repolarization predicts ventricular tachycardia and sudden cardiac death in patients with structural heart disease: a comparison with QT variability index. Heart Rhythm. 2011 Oct;8(10):1584-90. doi: 10.1016/j.hrthm.2011.04.033. Epub 2011 May 10.'}, {'pmid': '21091740', 'type': 'RESULT', 'citation': 'Tereshchenko LG, Henrikson CA, Stempniewicz P, Han L, Berger RD. Antiarrhythmic effect of reverse electrical remodeling associated with cardiac resynchronization therapy. Pacing Clin Electrophysiol. 2011 Mar;34(3):357-64. doi: 10.1111/j.1540-8159.2010.02974.x. Epub 2010 Nov 22.'}, {'pmid': '23416373', 'type': 'RESULT', 'citation': 'Chen X, Tereshchenko LG, Berger RD, Trayanova NA. Arrhythmia risk stratification based on QT interval instability: an intracardiac electrocardiogram study. Heart Rhythm. 2013 Jun;10(6):875-80. doi: 10.1016/j.hrthm.2013.02.014. Epub 2013 Feb 13.'}, {'pmid': '22995383', 'type': 'RESULT', 'citation': 'Das D, Han L, Berger RD, Tereshchenko LG. QT variability paradox after premature ventricular contraction in patients with structural heart disease and ventricular arrhythmias. J Electrocardiol. 2012 Nov-Dec;45(6):652-7. doi: 10.1016/j.jelectrocard.2012.07.016. Epub 2012 Sep 17.'}, {'pmid': '25752990', 'type': 'RESULT', 'citation': "Baumert M, Kabir MM, Dalouk K, Henrikson CA, Tereshchenko LG. VV' Alternans Triplets on Near-Field ICD Intracardiac Electrogram is Associated with Mortality. Pacing Clin Electrophysiol. 2015 May;38(5):547-57. doi: 10.1111/pace.12594. Epub 2015 Mar 9."}, {'pmid': '23964242', 'type': 'RESULT', 'citation': 'Guduru A, Lansdown J, Chernichenko D, Berger RD, Tereshchenko LG. Longitudinal changes in intracardiac repolarization lability in patients with implantable cardioverter-defibrillator. Front Physiol. 2013 Aug 12;4:208. doi: 10.3389/fphys.2013.00208. eCollection 2013.'}, {'pmid': '22750217', 'type': 'RESULT', 'citation': 'Tereshchenko LG, McCabe A, Han L, Sur S, Huang T, Marine JE, Cheng A, Spragg DD, Sinha S, Calkins H, Stein K, Tomaselli GF, Berger RD. Intracardiac J-point elevation before the onset of polymorphic ventricular tachycardia and ventricular fibrillation in patients with an implantable cardioverter-defibrillator. Heart Rhythm. 2012 Oct;9(10):1594-602. doi: 10.1016/j.hrthm.2012.06.036. Epub 2012 Jun 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether waveforms of the intracardiac electrograms, acquired through an ICD, can be used:\n\n* to predict malignant ventricular arrhythmias, requiring appropriate ICD therapies, and\n* to predict progression of heart failure in patients with ICD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ischemic or non-ischemic cardiomyopathy undergoing ICD implantation for primary or secondary prevention of sudden cardiac death', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* history of acute MI at least 4 weeks old\n* non-ischemic LV dysfunction for at least 9 months\n* who have an EF \\< or = to 35%\n* who was resuscitated from sudden cardiac arrest (ventricular tachyarrhythmia)\n* undergone implantation of an FDA-approved ICD for primary or secondary prevention of SCD\n\nExclusion Criteria:\n\n* inability or unwillingness to provide valid informed consent\n* pregnancy\n* any condition other than cardiac disease that was associated with a high likelihood of death during 1 year after enrollment'}, 'identificationModule': {'nctId': 'NCT00916435', 'acronym': 'ICD-EGMs', 'briefTitle': 'Study of the Implantable Cardioverter Defibrillator (ICD) Intracardiac Electrograms', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Prospective Observational Study of the ICD Intracardiac Electrograms for Prediction of Ventricular Tachyarrhythmias and Congestive Heart Failure', 'orgStudyIdInfo': {'id': '1K99HL094665-01 (in review)'}}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Larisa G Tereshchenko, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}, {'name': 'Ronald D Berger, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Washington University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor of Medicine', 'investigatorFullName': 'Larisa Tereshchenko', 'investigatorAffiliation': 'Johns Hopkins University'}}}}