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Clinical Trials/NCT05987891
NCT05987891
Completed
Not Applicable

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 site in 1 country400 target enrollmentAugust 30, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
University of Sao Paulo
Enrollment
400
Locations
1
Primary Endpoint
ECG abnormalities and risk factors
Status
Completed
Last Updated
11 months ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 30, 2023
End Date
March 26, 2025
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pedro Gabriel Senger Braga

Ph.D.

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

ECG abnormalities and risk factors

Time Frame: 1 year

Electrocardiogram suggestive of myocardial ischemia

Study Sites (1)

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