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临床试验/NCT05987891
NCT05987891已完成不适用

The Influence of Cardiovascular Risk Factors on Electrocardiographically and Hemodynamics Responses to Treadmill Exercise Test in Asymptomatically Subjects: a Clinical Perspective (ERGO-RISC)

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年8月30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
400
试验地点
1
主要终点
ECG abnormalities and risk factors

研究概览

简要总结

The goal of this observational cross-sectional study is to analyze the effect of cardiovascular risk factors in healthy and asymptomatic populations. The main questions it aims to answer are:

  • Does the combination of the presence of different risk factors increase the risk for abnormalities appearing on electrocardiograms, such as ischemia, arrhythmia, and hemodynamics effects during and at the peak of effort of treadmill exercise test?
  • What are the main differences observed in the recovery period? Participants will answer an anamnesis of risk factors such as sex, race, age, familiar history of coronary artery disease, overweight or obesity, smoking, stress, and physical activity practice and perform treadmill exercise test on Ellestad protocol. If there a comparison groups: Researchers will compare individuals with most risk factors with those without, to see the cardiovascular responses.

详细描述

The main outcomes broad the effect of simples and easy doccumented cardiovascular risk factors such as sex, race, age, familiar history of coronary artery disease, overweight or obesity, smoking, stress, and physical inactivity on electrocardiogram and hemodinamics abnormalities during and after exercise treadmill exercise test.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects that can complete the treadmill exercise test with the Ellestad protocol with 6 minutes of recovery.

排除标准

  • Use of remedies for blood pressure, glycemia, cholesterol, and serum lipids;
  • Symptomatically subjects;
  • Electrocardiogram that are not able to be interpreted;
  • Blood pressure in rest state ≥180 mmHg and ≥110 mmHg, for systolic and diastolic, respectively.

结局指标

主要结局

ECG abnormalities and risk factors

时间窗: 1 year

Electrocardiogram suggestive of myocardial ischemia

次要结局

未报告次要终点

研究者

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

Pedro Gabriel Senger Braga

Ph.D.

University of Sao Paulo

研究点 (1)

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