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临床试验/NCT03862235
NCT03862235已完成不适用

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

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Cardiac T1-mapping

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Cardiac T1-mapping

时间窗: 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.

次要结局

  • Myocardial Contractility(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Janieire de Nazaré Nunes Alves

Principal Investigator, MD, PhD

University of Sao Paulo General Hospital

研究点 (1)

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