Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT00181233
Status:
RECRUITING
Last Update Posted:
2025-01-10
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'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': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2029-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'cardiac transplantation', 'timeFrame': '6 month intervals'}, {'measure': 'myocardial revascularization', 'timeFrame': '6 month intervals'}, {'measure': 'left ventricular assist device placement', 'timeFrame': '6 month intervals'}, {'measure': 'biventricular pacemaker placement', 'timeFrame': '6 month intervals'}], 'primaryOutcomes': [{'measure': 'sudden cardiac death', 'timeFrame': '6 month intervals'}, {'measure': 'cardiovascular death', 'timeFrame': '6 month intervals'}, {'measure': 'appropriate ICD discharge', 'timeFrame': '6 month intervals'}, {'measure': 'composite sudden cardiac death and appropriate ICD discharge', 'timeFrame': '6 month intervals'}], 'secondaryOutcomes': [{'measure': 'heart failure admission', 'timeFrame': '6 month intervals'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sudden Cardiac Death']}, 'referencesModule': {'references': [{'pmid': '35579938', 'type': 'DERIVED', 'citation': 'Samuel TJ, Lai S, Schar M, Wu KC, Steinberg AM, Wei AC, Anderson ME, Tomaselli GF, Gerstenblith G, Bottomley PA, Weiss RG. Myocardial ATP depletion detected noninvasively predicts sudden cardiac death risk in patients with heart failure. JCI Insight. 2022 Jun 22;7(12):e157557. doi: 10.1172/jci.insight.157557.'}, {'pmid': '22267750', 'type': 'DERIVED', 'citation': 'Wu KC, Gerstenblith G, Guallar E, Marine JE, Dalal D, Cheng A, Marban E, Lima JA, Tomaselli GF, Weiss RG. Combined cardiac magnetic resonance imaging and C-reactive protein levels identify a cohort at low risk for defibrillator firings and death. Circ Cardiovasc Imaging. 2012 Mar;5(2):178-86. doi: 10.1161/CIRCIMAGING.111.968024. Epub 2012 Jan 20.'}, {'pmid': '18565399', 'type': 'DERIVED', 'citation': 'Wu KC, Weiss RG, Thiemann DR, Kitagawa K, Schmidt A, Dalal D, Lai S, Bluemke DA, Gerstenblith G, Marban E, Tomaselli GF, Lima JA. Late gadolinium enhancement by cardiovascular magnetic resonance heralds an adverse prognosis in nonischemic cardiomyopathy. J Am Coll Cardiol. 2008 Jun 24;51(25):2414-21. doi: 10.1016/j.jacc.2008.03.018.'}]}, 'descriptionModule': {'briefSummary': 'Sudden cardiac death is a tragic event that strikes all age groups and is unfortunately increasing in prevalence. Because it is difficult to predict those at highest risk, this study is designed to test the hypothesis that new imaging techniques (magnetic resonance imaging \\[MRI\\] and computed tomography \\[CT\\]) are useful for identifying factors which put people at high risk for sudden death.', 'detailedDescription': 'Some people with heart disease and a weak heart muscle experience abnormal electrical activity of the heart that may predispose them to sudden death. In light of this risk, it has been recommended that such patients undergo implantation of an implantable cardioverter defibrillator (ICD). Your doctors have determined that you are such a patient and are to undergo implantation of an ICD. It is unclear who among the many patients who undergo ICD implantation for this reason are at greatest risk of sudden death and therefore require electrical response from their ICD. This research is being done to determine whether new imaging tests, such as magnetic resonance imaging (MRI) or multi-detector computed tomography (MDCT), can be used to predict who is at highest risk of sudden death and require electrical response from their ICD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with contractile dysfunction (EF\\< or = 35%) on an ischemic or non-ischemic basis undergoing clinically-indicated ICD implantation for primary prevention of sudden cardiac death (SCD)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Left ventricular ejection fraction \\<or = 35%\n* Planned implantable cardioverter-defibrillator (ICD) implantation for clinical indications (primary prevention)\n\nExclusion Criteria:\n\n* History of sudden death (secondary prevention)\n* Contraindication to undergoing MRI (metallic implant, pacemaker, etc.)'}, 'identificationModule': {'nctId': 'NCT00181233', 'briefTitle': 'Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Functional Energetics and Imaging for Phenotypic Characterization of Patients at Risk for Sudden Cardiac Death', 'orgStudyIdInfo': {'id': 'NA_00037404'}}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tricia Steinberg, RN', 'role': 'CONTACT', 'email': 'asteinb3@jhmi.edu', 'phone': '443-287-3469'}], 'facility': 'Johns Hopkins Medical Institutions', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Barbara Butcher, RN', 'role': 'CONTACT', 'email': 'bbutche1@jhmi.edu', 'phone': '443-287-3472'}], 'overallOfficials': [{'name': 'Katherine C Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Donald W. Reynolds Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}