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CompletedNCT05987891ERGO-RISCUpdated Jun 5, 2025

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

An observational study in Cardiovascular Diseases, Cardiovascular Abnormalities and Healthy, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by University of Sao Paulo · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
400
Ages
18 Years to 90 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Cardiovascular Diseases
  • Cardiovascular Abnormalities
  • Healthy

Keywords

  • treadmill exercise test
  • asymptomatic subjects
  • Cardiovascular risk factor
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 400 is below the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy and assymptomatically subjects who are visiting cardiologyst for routine.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
400 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testTreadmill exercise stress test

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

06

What researchers measure

Primary outcomes

  1. ECG abnormalities and risk factors

    Electrocardiogram suggestive of myocardial ischemia

    Time frame: 1 year

07

Study locations

1 site
  • Pró-Coração
    São Paulo, SP 05021-010, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05987891
Lead sponsor
University of Sao Paulo
Responsible party
Pedro Gabriel Senger Braga (Ph.D., University of Sao Paulo) — Principal investigator
First posted
Aug 14, 2023
Start date
Aug 30, 2023
Primary completion
Mar 26, 2025
Completion
Mar 26, 2025
Last update
Jun 5, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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