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

NCT05987891 | Completed DMC

• 1 other identifier: Pró-Coração
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Cardiovascular Abnormalities; Healthy

Keywords

treadmill exercise test; asymptomatic subjects; Cardiovascular risk factor

Outcome Measures

Primary Outcomes (1)

• ECG abnormalities and risk factors

  Electrocardiogram suggestive of myocardial ischemia

  1 year

Study Arms (1)

Healthy controls

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.

Diagnostic Test: Treadmill exercise stress test

Interventions

Treadmill exercise stress test DIAGNOSTIC_TEST

Ellestad protocol will be applied in all subjects up to fatigue and recovery will be monitored.

Healthy controls

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy and assymptomatically subjects who are visiting cardiologyst for routine.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Pró-Coração

São Paulo, São Paulo, 05021-010, Brazil

Location

Related Publications (1)

• de Almeida Dourado JP, Azevedo LM, de Almeida Dourado L, de Oliveira JG, de Faria BB, de Oliveira Matos K, Roever L, Dourado PMM, Braga PGS. Association Between Psychosocial Stress and Premature Ventricular Contractions During the Recovery Phase Following Treadmill Testing in Asymptomatic Individuals. J Clin Med. 2025 Jun 30;14(13):4637. doi: 10.3390/jcm14134637.

  PMID: 40649011 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Cardiovascular Abnormalities

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 14, 2023
• Study Start: August 30, 2023
• Primary Completion: March 26, 2025
• Study Completion: March 26, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)