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

NCT03862235 | Completed

• 1 other identifier: CMR- AnabolicSteroids
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Focal Fibrosis

Keywords

anabolic steroid; T1-mapping; cardiac structure

Outcome Measures

Primary Outcomes (1)

• Cardiac T1-mapping

  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.

  1 day

Secondary Outcomes (1)

• Myocardial Contractility

  1 day

Study Arms (3)

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).

Diagnostic Test: Cardiovascular Magnetic Resonance; Diagnostic Test: Transthoracic echocardiography

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).

Diagnostic Test: Cardiovascular Magnetic Resonance; Diagnostic Test: Transthoracic echocardiography

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).

Diagnostic Test: Cardiovascular Magnetic Resonance; Diagnostic Test: Transthoracic echocardiography

Interventions

Cardiovascular Magnetic Resonance 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

Anabolic androgenic steroids nonusers; Anabolic androgenic steroids users; Sedentary control

Transthoracic echocardiography 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; Anabolic androgenic steroids users; Sedentary control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Anabolic androgenic steroids users and nonusers were recreational weightlifters or amateur bodybuilding athletes who were recruited from gymnasiums. Sedentary control group was recruited from community sample.

You may qualify if:

• 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.

You may not qualify if:

• Smoking;
• Alcohol consumption;
• Use of diuretics and/or antihypertensive medications;
• Liver and kidney disease

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

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

São Paulo, São Paulo, 05403-900, Brazil

Location

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Maria Janieire NN Alves, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 5, 2019
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2017
• Last Updated: March 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)