Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-31 @ 8:22 PM
Study NCT ID:
NCT02723851
Status:
UNKNOWN
Last Update Posted:
2016-03-31
First Post:
2016-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determining the Optimal Cut-off Point of PEA by Corsens Device for Discriminating Between MI and Non-MI Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-29', 'studyFirstSubmitDate': '2016-03-17', 'studyFirstSubmitQcDate': '2016-03-29', 'lastUpdatePostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" to verify safety', 'timeFrame': '1 day', 'description': 'To verify the safety of the Corsens technology while use for myocardial infarction detection.'}], 'secondaryOutcomes': [{'measure': 'To define the optimal cut-off point (in terms of sensitivity and specificity) of the PEA measured by Corsens technology for discriminating between MI and non-MI patient.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Acute Myocardial Infarction (MI) is still the leading cause of death in the western world. Early warning (chest pain) signs of an acute MI are often misinterpreted and disregarded. In average it takes between 2-3 hours from the beginning of the chest pain. The damage to the heart in these 2 hours is critical and often irreversible. Thus an early warning test or device is highly warranted.\n\nCorsens has developed a noninvasive device using several sensors applied to the chest and a detection system able to recognize the ischemic origin of chest pain. This clinical study is intended for evaluating the safety and efficacy of the Corsens technology while use for myocardial infarction detection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with ST-elevation acute MI will be recruited to the study. Additional data that was already recorded in previous study from non-MI patients hospitalized for routine elective catheterization will be used.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients admitted to the cardiac care unit (CCU) with ST elevation acute MI (STEMI) within 4 hours from beginning of chest pain.\n* Male or female subjects aged 18 years or more (with no upper limit), of any race.\n* Subjects willing to participate as evidenced by signing the written informed consent.\n\nExclusion Criteria:\n\n* Obese patients with BMI\\>35.\n* Subjects with cardiac arrhythmias including atrial fibrillation. Previous MI.\n* Patients after coronary artery bypass grafting\n* Unstable hemodynamic condition.\n* Patient that can't or do not wish to sign the Inform Consent Form"}, 'identificationModule': {'nctId': 'NCT02723851', 'briefTitle': 'Determining the Optimal Cut-off Point of PEA by Corsens Device for Discriminating Between MI and Non-MI Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corsens Medical LTD'}, 'officialTitle': 'An Open Label Study for Determining the Optimal Cut-off Point of Peak Endocardial Acceleration Measured by Corsens Device for Discriminating Between MI and Non-MI Subjects', 'orgStudyIdInfo': {'id': 'CS-COP-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute MI patients', 'description': 'Corsens Recording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index \\[MCI\\] and isovolumetric contraction (IVCT).', 'interventionNames': ['Device: Corsens']}, {'label': 'Non-MI patients', 'description': 'Corsens Recording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index \\[MCI\\] and isovolumetric contraction (IVCT).', 'interventionNames': ['Device: Corsens']}], 'interventions': [{'name': 'Corsens', 'type': 'DEVICE', 'description': 'Recording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index \\[MCI\\] and isovolumetric contraction (IVCT). Measurements will not affect the treatment provided to the patients.', 'armGroupLabels': ['Acute MI patients', 'Non-MI patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hanna Levy, Dr.', 'role': 'CONTACT', 'email': 'hanna@qsitemed.com', 'phone': '+972-52-2824966'}], 'overallOfficials': [{'name': 'Eugenia Nikolsky, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Medical Center, Haifa Israel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corsens Medical LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}