Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2026-01-04 @ 5:14 PM
Study NCT ID:
NCT03638050
Status:
UNKNOWN
Last Update Posted:
2018-08-20
First Post:
2018-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety of the 6-minute Walk Test After Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-16', 'studyFirstSubmitDate': '2018-07-27', 'studyFirstSubmitQcDate': '2018-08-16', 'lastUpdatePostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Six-minute walk test to measure functional capacity', 'timeFrame': 'Third day after acute myocardial infarction', 'description': 'By 6MWT assessing the functional capacity after acute myocardial infarction'}], 'secondaryOutcomes': [{'measure': 'Angina', 'timeFrame': 'Third day after acute myocardial infarction', 'description': 'To assess the occurrence of angina during the 6MWT'}, {'measure': 'Dyspnea', 'timeFrame': 'Third day after acute myocardial infarction', 'description': 'To assess the occurrence of dyspnea during the 6MWT'}, {'measure': 'Pallor', 'timeFrame': 'Third day after acute myocardial infarction', 'description': 'To assess the occurrence of pallor during the 6MWT'}, {'measure': 'Sweating', 'timeFrame': 'Third day after acute myocardial infarction', 'description': 'To assess the occurrence of sweating during the 6MWT'}, {'measure': 'Cramps', 'timeFrame': 'Third day after acute myocardial infarction', 'description': 'To assess the occurrence of cramps during the 6MWT'}, {'measure': 'Lower limbs fatigue', 'timeFrame': 'Third day after acute myocardial infarction', 'description': 'To assess the occurrence of lower limbs fatigue during the 6MWT'}, {'measure': 'Dizziness', 'timeFrame': 'Third day after acute myocardial infarction', 'description': 'To assess the occurrence of dizziness during the 6MWT'}, {'measure': 'Hospitalization stay', 'timeFrame': 'Thirty days after acute myocardial infarction', 'description': 'Duration of stay in the hospital (in days) will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction', 'Six-minute Walk Test']}, 'descriptionModule': {'briefSummary': "Background: The six-minute walk test (6MWT) is widely used as an instrument for assessing the functional capacity of cardiac patients. It's a simple, low cost test that better reflects day-to-day activities when compared to other tests. Its use to evaluate the functional capacity of cardiac patients in the in-hospital phase after acute myocardial infarction requires further studies. Objective: To evaluate the safety of the 6MWT performed on the third day after acute myocardial infarction (AMI). Methods: It's a cross-sectional study, to be accomplished in Hospital São Paulo - Federal University of Sao Paulo. Individuals, of both genders, aged 18 years and over, will be assessed on the third day after acute myocardial infarction. The 6MWT will be performed according to the norms of the American Thoracic Society. The distance covered during the 6MWT will be measured as weel as adverse events."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sequential AMI patients admitted to hospitalization in the third day after myocardial infarction', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AMI patients\n\nExclusion Criteria:\n\n* Previous history of AMI\n* Recurrent or refractory pain\n* Presence of neuromuscular diseases\n* Acute or chronic lung diseases\n* Inability to perform the functional test'}, 'identificationModule': {'nctId': 'NCT03638050', 'briefTitle': 'The Safety of the 6-minute Walk Test After Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'The Safety of the 6-minute Walk Test After Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': '58277816.7.0000.5505'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'In-hospital acute myocardial infarction patients', 'description': 'Functional Capacity Assessment', 'interventionNames': ['Other: Functional Capacity Assessment']}], 'interventions': [{'name': 'Functional Capacity Assessment', 'type': 'OTHER', 'description': 'Individuals will be assessed on the third day after acute myocardial infarction. The six-minute walk test will be performed according to the norms of the American Thoracic Society.', 'armGroupLabels': ['In-hospital acute myocardial infarction patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04024002', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Investigator', 'role': 'CONTACT', 'phone': '5511999297715'}], 'facility': 'Graciana Santos Martinhão', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Solange Guizilini, PhD', 'role': 'CONTACT', 'email': 's_guizilini@yahoo.com.br', 'phone': '5511982887753'}, {'name': 'Graciana Santos Martinhão', 'role': 'CONTACT', 'email': 'graciana_martinhao@hotmail.com', 'phone': '5511999297715'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Solange Guizilini', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}