Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo
São Paulo, 05403-900, Brazil
Completed
NCT Number: NCT03862235
Decreased T1 Times and Impaired Myocardial Contractility in Anabolic Androgenic Steroids Users
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Male
Study type
Observational
Primary location
About this study
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)
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Cardiovascular Magnetic Resonance
Diagnostic TestThe 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
Diagnostic TestThe 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.
Primary outcomes
-
Cardiac T1-mapping
Time frame: 1 day
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.
Secondary outcomes
-
Myocardial Contractility
Time frame: 1 day
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.
Sponsors and collaborators
Lead sponsor
University of Sao Paulo General Hospital
Other
Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
Registry information
Official study title
Decreased Myocardial Native T1 Times and Impaired Myocardial Contractility in Young Anabolic Androgenic Steroids Users
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2017
- First posted
- Mar 5, 2019
- Registry last updated
- Mar 5, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.