Cardiovascular Risk Factors on Electrocardiographically and Hemodynamics Responses to Treadmill Exercise Test

Recruiting

• Conditions: Cardiovascular Diseases; Healthy; Cardiovascular Abnormalities
• Interventions: Diagnostic Test: Treadmill exercise stress test

• Registration Number: NCT05987891
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-14
• Study Start: 2023-08-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-07
• Primary Completion: 2024-09-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	Treadmill exercise stress test	Volunteers will perform treadmill exercise tests. It will be monitored electrocardiogram, heart rate, and blood pressure in the rest state, under exercise, and in the recovery.

Primary Outcome Measures

Name	Time	Method
ECG abnormalities and risk factors	1 year	Electrocardiogram suggestive of myocardial ischemia

Trial Locations

Locations (1)

Pró-Coração; 🇧🇷 São Paulo, SP, Brazil