- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03862235
Decreased T1 Times and Impaired Myocardial Contractility in Anabolic Androgenic Steroids Users
Decreased Myocardial Native T1 Times and Impaired Myocardial Contractility in Young Anabolic Androgenic Steroids Users
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
SP
-
Sao Paulo, SP, Brazil, 05403-900
- Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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). |
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
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). |
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
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). |
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
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 day
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Maria Janieire NN Alves, MD, Heart Institute (InCor), University of Sao Paulo Medical School
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMR- AnabolicSteroids
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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