Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-01-02 @ 9:13 AM
Study NCT ID:
NCT03862235
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2019-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decreased T1 Times and Impaired Myocardial Contractility in Anabolic Androgenic Steroids Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-28', 'studyFirstSubmitDate': '2019-02-27', 'studyFirstSubmitQcDate': '2019-02-28', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac T1-mapping', 'timeFrame': '1 day', 'description': 'For the identification of microscopic interstitial fibrosis and the calculation of extracellular space volume (ECV) were use the T1-mapping technique, which use the Modified Lock-Locker (MOLLI) pulse sequence. It was performed for image acquisition, before contrast injection with 3 short-axis cuts, in order to define the baseline T1 of myocardium. The evaluation of the MOLLI sequence images at 4 different times has the objective of evaluating the recovery of T1 times after contrast injection, which allows, associated with hematocrit, the calculation of myocardial extracellular space that is directly related to fibrosis in validation studies with endomyocardial biopsy.'}], 'secondaryOutcomes': [{'measure': 'Myocardial Contractility', 'timeFrame': '1 day', 'description': 'To calculate the left ventricular function, the strain values were used. Using the speckle-tracking technique, the value of the global longitudinal strain (GLS) was extracted through the three apical views, later the mean of 17 myocardial segments was calculated. Normal value for GLS was set to -18%, although in the literature there is no standardized value. Circumferential and radial strain values were estimated by short-axis parasternal views.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anabolic steroid', 'T1-mapping', 'cardiac structure'], 'conditions': ['Focal Fibrosis']}, 'descriptionModule': {'briefSummary': 'Anabolic androgenic steroids (AAS) abuse may have a toxic on myocardium that could lead to cardiac alterations. Clinical cases reported myocardial fibrosis in AAS users. However, recent studies did not find myocardial fibrosis in AAS users using T1-mapping technique. The aim of this study was to evaluate cardiac structure by cardiovascular magnetic resonance (CMR) with late-gadolinium enhancement (LGE), cardiac T1-mapping and extracellular volume (ECV). We also evaluated the cardiac contractility in AAS users.', 'detailedDescription': 'Twenty strength-trained AAS users (AASU) age 29±5 yr, 20 age-matched strength-trained AAS nonusers (AASNU), and 10 sedentary controls (SC) were enrolled.\n\nCardiac structure was assessed by LGE, T1-mapping and ECV. Cardiac contractility was evaluated as cardiac strain by CMR (feature tracking) and echocardiography (speckle tracking)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Anabolic androgenic steroids users and nonusers were recreational weightlifters or amateur bodybuilding athletes who were recruited from gymnasiums.\n\nSedentary control group was recruited from community sample.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anabolic androgenic steroids users and Anabolic androgenic steroids nonusers groups had been involved in strength training for at least 2 years;\n* Anabolic androgenic steroids users should be self-administering anabolic androgenic steroids in periodic cycles lasting from 8 to 12 weeks for at least 2 years with 2-4 cycles per year;\n* All anabolic androgenic steroids users were on a cycle over the course of the study;\n* Sedentary control group: sedentary men without cardiovascular disease.\n\nExclusion Criteria:\n\n* Smoking;\n* Alcohol consumption;\n* Use of diuretics and/or antihypertensive medications;\n* Liver and kidney disease'}, 'identificationModule': {'nctId': 'NCT03862235', 'briefTitle': 'Decreased T1 Times and Impaired Myocardial Contractility in Anabolic Androgenic Steroids Users', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Decreased Myocardial Native T1 Times and Impaired Myocardial Contractility in Young Anabolic Androgenic Steroids Users', 'orgStudyIdInfo': {'id': 'CMR- AnabolicSteroids'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anabolic androgenic steroids users', 'description': 'This group had been involved in strength training for at least 2 years, self-administering anabolic androgenic steroids in periodic cycles lasting from 8 to 12 weeks for at least 2 years with 2-4 cycles per year. All participants were on a cycle over the course of the study.\n\nCardiovascular magnetic resonance (CMR) with late-gadolinium enhancement (LGE), cardiac T1-mapping and extracellular volume (ECV). Cardiac contractility was evaluated as cardiac strain by CMR (feature tracking) and transthoracic echocardiography (speckle tracking).', 'interventionNames': ['Diagnostic Test: Cardiovascular Magnetic Resonance', 'Diagnostic Test: Transthoracic echocardiography']}, {'label': 'Anabolic androgenic steroids nonusers', 'description': 'This group had been involved in strength training for at least 2 years and they have never took anabolic androgenic steroids.\n\nCardiovascular magnetic resonance (CMR) with late-gadolinium enhancement (LGE), cardiac T1-mapping and extracellular volume (ECV). Cardiac contractility was evaluated as cardiac strain by CMR (feature tracking) and transthoracic echocardiography (speckle tracking).', 'interventionNames': ['Diagnostic Test: Cardiovascular Magnetic Resonance', 'Diagnostic Test: Transthoracic echocardiography']}, {'label': 'Sedentary control', 'description': 'This group were sedentary men without cardiovascular disease.\n\nCardiovascular magnetic resonance (CMR) with late-gadolinium enhancement (LGE), cardiac T1-mapping and extracellular volume (ECV). Cardiac contractility was evaluated as cardiac strain by CMR (feature tracking) and transthoracic echocardiography (speckle tracking).', 'interventionNames': ['Diagnostic Test: Cardiovascular Magnetic Resonance', 'Diagnostic Test: Transthoracic echocardiography']}], 'interventions': [{'name': 'Cardiovascular Magnetic Resonance', 'type': 'DIAGNOSTIC_TEST', 'description': 'The patients underwent to CMR examination on a Philips Achieve 1.5 device. Images were acquired coupled to the electrocardiogram and during respiratory pause, in four chambers, short axis and long axis of the left ventricle, in the same exact location in different sequences. A gradient - echo sequence (steady-state free precession) was used to evaluate cardiac function (functional evaluation). We will also evaluate T1 weighted images (T1 -relaxation times) and T2, performed sequentially, through spin-echo pulse (black-blood), triple inversion recovery sequence, for the morphological evaluation', 'armGroupLabels': ['Anabolic androgenic steroids nonusers', 'Anabolic androgenic steroids users', 'Sedentary control']}, {'name': 'Transthoracic echocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'The images were collected by the Vivid E9. The patients were submitted to one-dimensional (M-mode), two-dimensional (B-mode), and three-dimensional (three-dimensional) echocardiographic studies. The images obtained were associated with pulsed, continuous and color Doppler.', 'armGroupLabels': ['Anabolic androgenic steroids nonusers', 'Anabolic androgenic steroids users', 'Sedentary control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Maria Janieire NN Alves, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Institute (InCor), University of Sao Paulo Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, MD, PhD', 'investigatorFullName': 'Maria Janieire de Nazaré Nunes Alves', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}