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

NCT ID: NCT05987891

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2025-03-26

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.

Conditions

Cardiovascular Diseases; Cardiovascular Abnormalities; Healthy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Treadmill exercise stress test

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Treadmill exercise stress test

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

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Pedro Gabriel Senger Braga

Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pró-Coração

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 40649011 (View on PubMed)

Other Identifiers

Pró-Coração

Identifier Type: -

Identifier Source: org_study_id