Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-01-25 @ 11:50 PM
Study NCT ID:
NCT02124018
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2014-04-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Risk Stratification in Patients With Preserved Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kgatzoul@med.uoa.gr', 'phone': '6944580369', 'title': 'Professor Konstantinos A. Gatzoulis', 'phoneExt': '0030', 'organization': 'First Department of Cardiology, School of Medicine, National and Kapodistrian University of Athens'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study was not a randomized clinical trial since almost all patients with a per protocol indication received a device, without the presence of a high-risk control group, thus potentially overestimating true arrhythmic risk.'}}, 'adverseEventsModule': {'timeFrame': 'From stratification completion (allocation to one of risk level groups) to adverse event occurrence, or study completion - mean 32 months', 'description': 'Adverse events due to PVS and ICD implantation', 'eventGroups': [{'id': 'EG000', 'title': 'Low Risk Group', 'description': 'No NIRFs present - no invasive PVS performed', 'otherNumAtRisk': 371, 'deathsNumAtRisk': 371, 'otherNumAffected': 0, 'seriousNumAtRisk': 371, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intermediate Risk Group', 'description': 'At least one NIRF present - noninducible upon PVS', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 0, 'seriousNumAtRisk': 111, 'deathsNumAffected': 4, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'High Risk Group', 'description': 'At least one NIRF present AND inducible upon PVS.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Major Arrhythmic Events (MAEs) - Present When One of the Following Occurred: Sudden Cardiac Death, Sustained Ventricular Tachycardia, or Implantable Cardioverter - Defibrillator (ICD) Activation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Risk Group', 'description': 'No NIRFs present - no invasive PVS performed'}, {'id': 'OG001', 'title': 'Intermediate Risk Group', 'description': 'At least one NIRF present - noninducible upon PVS'}, {'id': 'OG002', 'title': 'High Risk Group', 'description': 'At least one NIRF present AND inducible upon PVS.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From stratification completion (i.e. allocation to one of three risk level groups) until either occurrence of primary endpoint or study completion (mean 32months) - study stopped early due to emergence of clearly defined high risk subgroup', 'description': 'The number of patients from each risk level group meeting the primary endpoint will be used to assess diagnostic accuracy (positive/negative predictive value, sensitivity and specificity) of the proposed two-stage, PVS-inclusive, risk stratification approach for the allocation of an ICD', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Risk Group', 'description': 'No Non-Invasive Risk Factors (NIRFs) present - no invasive programmed ventricular stimulation (PVS) performed'}, {'id': 'OG001', 'title': 'Intermediate Risk Group', 'description': 'At least one NIRF present - noninducible upon programmed ventricular stimulation (PVS) (no sustained ventricular tachyarrhythmia was induced i.e. either with a duration \\>30seconds or causing hemodynamic instability necessitating termination)'}, {'id': 'OG002', 'title': 'High Risk Group', 'description': 'At least one NIRF present AND inducible upon PVS (sustained ventricular tachyarrhythmia was induced).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From completion of risk stratification to study completion or outcome occurrence (mean 32 months)', 'description': 'All-cause mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Risk Group', 'description': 'No Non-Invasive Risk Factors (NIRFs) present - no invasive programmed ventricular stimulation (PVS) performed'}, {'id': 'FG001', 'title': 'Intermediate Risk Group', 'description': 'At least one NIRF present - noninducible upon programmed ventricular stimulation (PVS) (no sustained ventricular tachyarrhythmia was induced i.e. either with a duration \\>30seconds or causing hemodynamic instability necessitating termination)'}, {'id': 'FG002', 'title': 'High Risk Group', 'description': 'At least one NIRF present AND inducible upon PVS (sustained ventricular tachyarrhythmia was induced).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '371'}, {'groupId': 'FG001', 'numSubjects': '111'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '371'}, {'groupId': 'FG001', 'numSubjects': '111'}, {'comment': 'Numbers do not add up to 575 (enrolled) due to refusals of programmed ventricular stimulation', 'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'From April 2014 to July 2018, 575 consecutive patients were enrolled in the seven Departments of Cardiology participating in the study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '523', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Risk Group', 'description': 'No NIRFs present - no invasive PVS performed'}, {'id': 'BG001', 'title': 'Intermediate Risk Group', 'description': 'At least one NIRF present - noninducible upon PVS'}, {'id': 'BG002', 'title': 'High Risk Group', 'description': 'At least one NIRF present AND inducible upon PVS'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '523', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '55.7', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '60', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '61.7', 'spread': '9.2', 'groupId': 'BG002'}, {'value': '57', 'spread': '10.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '523', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '314', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '450', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Greece', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '523', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '371', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '523', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': "Due to some patients' refusal to be submitted to invasive programmed ventricular stimulation, 52 patients were unstratifiable (unknown if Group 2 or 3), and thus 371+111+41=523=575-52"}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-23', 'size': 241814, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-15T12:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 575}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-23', 'studyFirstSubmitDate': '2014-04-24', 'resultsFirstSubmitDate': '2019-04-16', 'studyFirstSubmitQcDate': '2014-04-24', 'lastUpdatePostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-15', 'studyFirstPostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Major Arrhythmic Events (MAEs) - Present When One of the Following Occurred: Sudden Cardiac Death, Sustained Ventricular Tachycardia, or Implantable Cardioverter - Defibrillator (ICD) Activation', 'timeFrame': 'From stratification completion (i.e. allocation to one of three risk level groups) until either occurrence of primary endpoint or study completion (mean 32months) - study stopped early due to emergence of clearly defined high risk subgroup', 'description': 'The number of patients from each risk level group meeting the primary endpoint will be used to assess diagnostic accuracy (positive/negative predictive value, sensitivity and specificity) of the proposed two-stage, PVS-inclusive, risk stratification approach for the allocation of an ICD'}], 'secondaryOutcomes': [{'measure': 'Total Mortality', 'timeFrame': 'From completion of risk stratification to study completion or outcome occurrence (mean 32 months)', 'description': 'All-cause mortality'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myocardial infarction', 'Risk stratification', 'Sudden cardiac death', 'Preserved ejection fraction', 'Programmed ventricular stimulation'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '31049557', 'type': 'DERIVED', 'citation': 'Gatzoulis KA, Tsiachris D, Arsenos P, Antoniou CK, Dilaveris P, Sideris S, Kanoupakis E, Simantirakis E, Korantzopoulos P, Goudevenos I, Flevari P, Iliodromitis E, Sideris A, Vassilikos V, Fragakis N, Trachanas K, Vernardos M, Konstantinou I, Tsimos K, Xenogiannis I, Vlachos K, Saplaouras A, Triantafyllou K, Kallikazaros I, Tousoulis D. Arrhythmic risk stratification in post-myocardial infarction patients with preserved ejection fraction: the PRESERVE EF study. Eur Heart J. 2019 Sep 14;40(35):2940-2949. doi: 10.1093/eurheartj/ehz260.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the prevalence and the prognostic value of non-invasive indexes and programmed ventricular stimulation for sudden cardiac death in post-myocardial infarction (MI) patients with left ventricular ejection fraction (LVEF)\\>40%.', 'detailedDescription': '1000 asymptomatic post-MI patients\\>40%, at least 40 days post-MI, revascularized or without needing further revascularization (in any case without any evidence of ischemia) will be enrolled.\n\nThe patients will be divided into two categories:\n\n1. Asymptomatic patients with revascularized ST-elevation MI (STEMI) (remaining stenoses in non culprit vessels \\<70%) at 40 days post-MI (when LVEF\\>40% will be re-assessed)\n2. Asymptomatic patients late (at any time after 40 days) after MI (initially STEMI-NSTEMI at discharge Q-non Q) with LVEF\\>40% right after a negative stress test or right after a negative for stenoses control coronary catheterization All patients will undergo non-invasive evaluation (ECG, Holter monitoring and 45-min high resolution recording). In case they fulfill at least one out of seven pre-specified criteria they will undergo programmed ventricular stimulation and implantable cardioverter-defibrillator (ICD) implantation (if inducible) All patients will be followed-up for 3 years for sudden cardiac death and its surrogate (appropriate ICD activation)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1000 asymptomatic post-MI patients\\>40%, at least 40 days post-MI, revascularized or without needing further revascularization (in any case without any evidence of ischemia)\n\nThe patients will be divided into two categories:\n\n1. Asymptomatic patients with revascularized STEMI (remaining stenoses in non culprit vessels \\<70%) at 40 days post-MI (when LVEF\\>40% will be re-assessed)\n2. Asymptomatic patients late after MI (initially STEMI-NSTEMI at discharge Q-non Q) with LVEF\\>40% right after a negative stress test or right after a negative for stenoses control coronary catheterization', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asymptomatic patients with revascularized STEMI (remaining stenoses in non culprit vessels \\<70%) at 40 days post-MI (when LVEF\\>40% will be re-assessed)\n* Asymptomatic patients late after MI (initially STEMI-NSTEMI at discharge Q-non Q) with LVEF\\>40% right after a negative stress test or right after a negative for stenoses control coronary catheterization\n\nExclusion Criteria:\n\n* Episodes of sustained VT or aborted sudden cardiac death (SCD) 48 hours after the acute MI phase.\n* Episodes of syncope within the last 6 months\n* Cancer, liver failure (cirrhosis), end-stage renal disease\n* Use of anti-arrhythmic drugs other than b-blockers'}, 'identificationModule': {'nctId': 'NCT02124018', 'acronym': 'PRESERVE-EF', 'briefTitle': 'Risk Stratification in Patients With Preserved Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'University of Athens'}, 'officialTitle': 'Post Myocardial Infarction Risk Stratification for Sudden Cardiac Death in Patients With Preserved Ejection Fraction: PRESERVE-EF', 'orgStudyIdInfo': {'id': 'UOA-PRESERVE1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Post-MI patients', 'description': 'Asymptomatic post-MI patients late after MI or 40 days after STEMI-NSTEMI with preserved ejection fraction and absence of active ischemia Programmed ventricular stimulation (PVS) will be performed in high-risk patients based on non-invasive evaluation.\n\nICD implantation will be performed in patients with induced ventricular tachycardia (VT) upon PVS', 'interventionNames': ['Procedure: Programmed ventricular stimulation', 'Device: ICD implantation']}], 'interventions': [{'name': 'Programmed ventricular stimulation', 'type': 'PROCEDURE', 'description': 'Programmed ventricular stimulation in high-risk patients based on non-invasive evaluation', 'armGroupLabels': ['Post-MI patients']}, {'name': 'ICD implantation', 'type': 'DEVICE', 'description': 'ICD implantation in patients with induced VT in programmed ventricular stimulation', 'armGroupLabels': ['Post-MI patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'First Cardiology Clinic, Hippokration Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Konstantinos Gatzoulis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Athens, Hippokration Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Athens', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}, {'name': 'General Electric', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Professor of Cardiology', 'investigatorFullName': 'Kostantinos A. Gatzoulis', 'investigatorAffiliation': 'University of Athens'}}}}