Decreased T1 Times and Impaired Myocardial Contractility in Anabolic Androgenic Steroids Users

NCT ID: NCT03862235

Last Updated: 2019-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-01

Study Completion Date

2017-04-01

Brief Summary

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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.

Detailed Description

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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.

Cardiac structure was assessed by LGE, T1-mapping and ECV. Cardiac contractility was evaluated as cardiac strain by CMR (feature tracking) and echocardiography (speckle tracking)

Conditions

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Focal Fibrosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Anabolic androgenic steroids users

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.

Cardiovascular 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).

Cardiovascular Magnetic Resonance

Intervention Type DIAGNOSTIC_TEST

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

Transthoracic echocardiography

Intervention Type DIAGNOSTIC_TEST

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.

Anabolic androgenic steroids nonusers

This group had been involved in strength training for at least 2 years and they have never took anabolic androgenic steroids.

Cardiovascular 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).

Cardiovascular Magnetic Resonance

Intervention Type DIAGNOSTIC_TEST

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

Transthoracic echocardiography

Intervention Type DIAGNOSTIC_TEST

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.

Sedentary control

This group were sedentary men without cardiovascular disease.

Cardiovascular 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).

Cardiovascular Magnetic Resonance

Intervention Type DIAGNOSTIC_TEST

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

Transthoracic echocardiography

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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Cardiovascular Magnetic Resonance

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

Intervention Type DIAGNOSTIC_TEST

Transthoracic echocardiography

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Anabolic androgenic steroids users and Anabolic androgenic steroids nonusers groups had been involved in strength training for at least 2 years;
* 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;
* All anabolic androgenic steroids users were on a cycle over the course of the study;
* Sedentary control group: sedentary men without cardiovascular disease.

Exclusion Criteria

* Smoking;
* Alcohol consumption;
* Use of diuretics and/or antihypertensive medications;
* Liver and kidney disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Maria Janieire de Nazaré Nunes Alves

Principal Investigator, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Janieire NN Alves, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute (InCor), University of Sao Paulo Medical School

Locations

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Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CMR- AnabolicSteroids

Identifier Type: -

Identifier Source: org_study_id

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