Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-26 @ 6:27 PM
Study NCT ID:
NCT03494751
Status:
UNKNOWN
Last Update Posted:
2019-04-08
First Post:
2018-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Monitoring Device After Acute Myocardium Infarction
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 358}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-04', 'studyFirstSubmitDate': '2018-01-22', 'studyFirstSubmitQcDate': '2018-04-04', 'lastUpdatePostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rhythm monitoring', 'timeFrame': 'One year', 'description': 'Evaluating the effectiveness of a heart monitoring device in the prevention and detection of events in patients after acute myocardial infarction'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Monitoring', 'Myocardial infarction', 'Clinical trial'], 'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Verify the effectiveness of a Heart Monitor in preventing events in patients over 18 years after acute myocardial infarction in a clinical unit. Patients with neurological disease or congenital heart disease we excluded from the study.', 'detailedDescription': 'Heart Monitor can detect early intercurrences. Objective: To verify the effectiveness of a Heart Monitoring system in preventing events in patients after acute myocardial infarction. Methodology: This is a randomized clinical trial to be developed in a clinical unit and will include patients over 18 years , post-acute myocardial infarction who were transferred from the ICU emergency or hemodynamic to clinical unit. Patients with neurological disease or congenital heart disease will be excluded from the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients over 18 years\n* patients post-acute myocardial infarctium\n\nExclusion Criteria:\n\n* patients with neurological disease\n* patients with congenital heart disease'}, 'identificationModule': {'nctId': 'NCT03494751', 'acronym': 'Monitor', 'briefTitle': 'Heart Monitoring Device After Acute Myocardium Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Cardiologia do Rio Grande do Sul'}, 'officialTitle': 'Heart Monitoring Device After Acute Myocardium Infarction', 'orgStudyIdInfo': {'id': '5391/17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Heart Monitor', 'description': 'We used the device (heart monitor) in the patients with myocardial infarction.', 'interventionNames': ['Device: Heart monitor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No Heart Monitor', 'description': 'No heart monitor device in the patients with myocardial infarction (control).', 'interventionNames': ['Device: No heart monitor']}], 'interventions': [{'name': 'Heart monitor', 'type': 'DEVICE', 'otherNames': ['Heart monitor device'], 'description': 'Use of heart monitor device in the patients after acute myocardium infarct.', 'armGroupLabels': ['Heart Monitor']}, {'name': 'No heart monitor', 'type': 'DEVICE', 'otherNames': ['No heart monitor device'], 'description': 'Standard monitoring by nurses.', 'armGroupLabels': ['No Heart Monitor']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'silvia goldmeier, doctor', 'role': 'CONTACT', 'email': 'sgoldmeier@gmail.com', 'phone': '5132354127'}, {'name': 'manoela vargas, student', 'role': 'CONTACT', 'email': 'vargas.manoela@gmail.com', 'phone': '5132354127'}], 'overallOfficials': [{'name': 'silvia goldmeier', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto de Cardiologia do Rio Grande do Sul'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Cardiologia do Rio Grande do Sul', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}