ERGO-RISC: Cardiovascular Risk Factors on Electrocardiographically and Hemodynamics Responses to Treadmill Exercise Test

Sponsor
University of Sao Paulo (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05987891
Collaborator
(none)
200
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Treadmill exercise stress test

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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
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)
Anticipated Study Start Date :
Nov 30, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

Arm Intervention/Treatment
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
Ellestad protocol will be applied in all subjects up to fatigue and recovery will be monitored.

Outcome Measures

Primary Outcome Measures

  1. ECG abnormalities and risk factors [1 year]

    Electrocardiogram suggestive of myocardial ischemia

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pedro Gabriel Senger Braga, Ph.D., University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT05987891
Other Study ID Numbers:
  • Pró-Coração
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pedro Gabriel Senger Braga, Ph.D., University of Sao Paulo
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2023