Cardiovascular DiseasesERGO-RISCNCT05987891
Cardiovascular Risk Factors on Electrocardiographically and Hemodynamics Responses to Treadmill Exercise Test
An observational study of Cardiovascular Diseases and Cardiovascular Abnormalities, run by University of Sao Paulo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Abnormalities, Healthy
- What is being tested?
- Treadmill exercise stress test
- How many people
- 400 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Aug 2023to 26 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy and assymptomatically subjects who are visiting cardiologyst for routine.
Who may be able to join
- Subjects that can complete the treadmill exercise test with the Ellestad protocol with 6 minutes of recovery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Being tested
- Treadmill exercise stress test
- Keywords
- treadmill exercise test, asymptomatic subjects, Cardiovascular risk factor
- Medical subject headings
- Cardiovascular Diseases, Cardiovascular Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill exercise stress testDiagnostic test
Ellestad protocol will be applied in all subjects up to fatigue and recovery will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Treadmill exercise stress test |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG abnormalities and risk factors
Electrocardiogram suggestive of myocardial ischemia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start30 Aug 2023
- Primary completion26 Mar 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Gabriel Senger Braga, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987891
- Sponsor's protocol ID
- Pró-Coração
- Acronym
- ERGO-RISC
- Status last verified
- Mar 2025
- First submitted
- 25 Jul 2023
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40649011
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05987891
- Acronym / sponsor ID
- ERGO-RISC / Pró-Coração
- Keywords
- treadmill exercise test, asymptomatic subjects, Cardiovascular risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Diagnostic Test: Treadmill exercise stress testVolunteers 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy and assymptomatically subjects who are visiting cardiologyst for routine.
Key inclusion criteria (1 listed)
- Subjects that can complete the treadmill exercise test with the Ellestad protocol with 6 minutes of recovery.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill exercise stress testEllestad protocol will be applied in all subjects up to fatigue and recovery will be monitored. | Diagnostic test | Healthy controls |
Primary outcome
ECG abnormalities and risk factors
Time frame: 1 year
Electrocardiogram suggestive of myocardial ischemia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Derived from this study: PubMed 40649011de 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cardiovascular Abnormalities, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG abnormalities and risk factors (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05987891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.