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

Healthy Clinical Trial

— ERGO-RISC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05987891
• Other study ID #: Pró-Coração
• Status: Recruiting
• Start date: August 30, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: September 2023
• Source: University of Sao Paulo
• Contact: Pedro GS Braga, Ph.D.
• Phone: 5511 94104-4044
• Email: pedro.senger[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Abnormalities
• Cardiovascular Diseases
• Healthy

Intervention

Diagnostic Test:
• Treadmill exercise stress test
Ellestad protocol will be applied in all subjects up to fatigue and recovery will be monitored.

Locations

Country	Name	City	State
Brazil	Pró-Coração	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECG abnormalities and risk factors	Electrocardiogram suggestive of myocardial ischemia	1 year