SurgeryNCT05778981
Endothelial Dysfunction and Non-cardiac Surgery
An observational study of Surgery and Cardiac Death, run by University of Chile at 1 site in Chile.
Trial summary
Endothelial dysfunction is a cardiovascular disease hallmark. After non-cardiac surgery, cardiovascular events correlate with surgical outcomes. Understanding the role of endothelial function in these events is crucial. This research aims to study endothelial function and its association with cardiovascular events. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery, Cardiac Death, Stroke
- What is being tested?
- FMD - Troponin measurement
- How many people
- 200 participants
- Where
- 1 siteChile
- Study dates
- 25 Mar 2023to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for non-cardiac surgery of 45 years old and older.
Who may be able to join
- Signed informed consent
- Patients 45 years or older
Who cannot join
- Refuse to participate in the study
- Myocardial injury or acute myocardial infarction less than two weeks ago
- Patients who expect less than 2 days of hospitalization
- Patients in whom the troponin elevation is attributed to a secondary cause (for example, sepsis, pulmonary thromboembolism, electrical cardioversion, etc.)
- Use of chemotherapy less than 2 weeks ago
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Hospital Clínico de la Universidad de Chile
Independencia, Santiago Metropolitan, 8380456
Felipe Maldonado, M.D., M.Sc.
Roberto González, M.D.
About this study
Official title: Endothelial Dysfunction During Non-cardiac Surgery and Major Clinical Events
Endothelial dysfunction is a cardiovascular disease hallmark. After non-cardiac surgery, cardiovascular events correlate with surgical outcomes. Understanding the role of endothelial function in these events is crucial.
This research aims to study endothelial function and its association with cardiovascular events.
Read the detailed description
To study the presence of endothelial damage and its association with cardiac events, the investigators will perform an observational study to evaluate flow-induced dilatation of the brachial artery in patients scheduled for non-cardiac surgery.
After ethical review board approval, the investigators will select 200 patients admitted for non-cardiac surgery. After the patient written consent, the investigators will perform an ultrasound evaluation of the brachial artery flow-mediated dilatation. This will be performed before, during, and after surgery. A basal troponin level will be obtained and repeatedly measured in the three days after surgery.
The investigators will observe clinical outcomes one, 3, and 6 months after the hospitalization.
To observe 8% of events, for a 5% alpha and 80% power, 161 patients are needed for our study. The authors considered that to account for a loss of 10% of patients, a sample of 177 patients will be required. Considering no national or local incidence of cardiovascular events, we aim to complete a 200-patient selection.
- Conditions
- Surgery, Cardiac Death, Stroke, Myocardial Injury
- Being tested
- FMD - Troponin measurement
- Keywords
- FMD, Flow-Mediated Dilatation, Troponin
- Medical subject headings
- Death, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMD - Troponin measurementDiagnostic test
Echographic FMD evaluation. Pre and post-operative troponin measurements.
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Cardiac Events
Result composed of myocardial infarction, cardiac arrest, and Death
Measured: 7 days after surgery
Major Cardiac Events
Result composed of myocardial infarction, cardiac arrest, and Death
Measured: 1 month after surgery
Major Cardiac Events
Result composed of myocardial infarction, cardiac arrest, and Death
Measured: 3 months after surgery
Major Cardiac Events
Result composed of myocardial infarction, cardiac arrest, and Death
Measured: 6 months after surgery
Secondary outcomes (7)
Myocardial Injury
Troponin I elevation
Measured: 1 day after surgery
Myocardial Injury
Troponin I elevation
Measured: 2 days after surgery
Myocardial Injury
Troponin I elevation
Measured: 3 days after surgery
Stroke
Stroke incidence after surgery
Measured: 7 days after surgery
Stroke
Stroke incidence after surgery
Measured: 1 month after surgery
Stroke
Stroke incidence after surgery
Measured: 3 months after surgery
Stroke
Stroke incidence after surgery
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start25 Mar 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Responsible party
- Principal investigator, Felipe Andrés Maldonado Caniulao, University of Chile
- Investigators
- Felipe Maldonado||, M.D.,M.Sc., Study chair, Hospital Clinico de la Universidad de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778981
- Sponsor's protocol ID
- OAIC 1316/22
- Status last verified
- Dec 2024
- First submitted
- 21 Feb 2023
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction During Non-cardiac Surgery and Major Clinical Events
- ClinicalTrials.gov ID
- NCT05778981
- Acronym / sponsor ID
- OAIC 1316/22
- Conditions
- Surgery, Cardiac Death, Stroke, Myocardial Injury
- Keywords
- FMD, Flow-Mediated Dilatation, Troponin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Study start
- 25 Mar 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 22 Mar 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.
Endothelial dysfunction is a cardiovascular disease hallmark. After non-cardiac surgery, cardiovascular events correlate with surgical outcomes. Understanding the role of endothelial function in these events is crucial.
This research aims to study endothelial function and its association with cardiovascular events.
Detailed description
To study the presence of endothelial damage and its association with cardiac events, the investigators will perform an observational study to evaluate flow-induced dilatation of the brachial artery in patients scheduled for non-cardiac surgery.
After ethical review board approval, the investigators will select 200 patients admitted for non-cardiac surgery. After the patient written consent, the investigators will perform an ultrasound evaluation of the brachial artery flow-mediated dilatation. This will be performed before, during, and after surgery. A basal troponin level will be obtained and repeatedly measured in the three days after surgery.
The investigators will observe clinical outcomes one, 3, and 6 months after the hospitalization.
To observe 8% of events, for a 5% alpha and 80% power, 161 patients are needed for our study. The authors considered that to account for a loss of 10% of patients, a sample of 177 patients will be required. Considering no national or local incidence of cardiovascular events, we aim to complete a 200-patient selection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for non-cardiac surgery of 45 years old and older.
Key inclusion criteria (2 listed)
- Signed informed consent
- Patients 45 years or older
Key exclusion criteria (5 listed)
- Refuse to participate in the study
- Myocardial injury or acute myocardial infarction less than two weeks ago
- Patients who expect less than 2 days of hospitalization
- Patients in whom the troponin elevation is attributed to a secondary cause (for example, sepsis, pulmonary thromboembolism, electrical cardioversion, etc.)
- Use of chemotherapy less than 2 weeks ago
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 |
|---|---|---|
| FMD - Troponin measurementEchographic FMD evaluation. Pre and post-operative troponin measurements. | Diagnostic test | – |
Primary outcome
Major Cardiac Events
Time frame: 7 days after surgery
Result composed of myocardial infarction, cardiac arrest, and Death
Major Cardiac Events
Time frame: 1 month after surgery
Result composed of myocardial infarction, cardiac arrest, and Death
Major Cardiac Events
Time frame: 3 months after surgery
Result composed of myocardial infarction, cardiac arrest, and Death
Major Cardiac Events
Time frame: 6 months after surgery
Result composed of myocardial infarction, cardiac arrest, and Death
7 secondary outcomes
Myocardial Injury
Time frame: 1 day after surgery
Myocardial Injury
Time frame: 2 days after surgery
Myocardial Injury
Time frame: 3 days after surgery
Stroke
Time frame: 7 days after surgery
Stroke
Time frame: 1 month after surgery
Stroke
Time frame: 3 months after surgery
Stroke
Time frame: 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- 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.
Felipe Maldonado||, M.D.,M.Sc. study chair
Hospital Clinico de la Universidad de Chile
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 Surgery and Cardiac Death, run by University of Chile at 1 site in Chile.
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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 10 Dec 2024. 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 Chile. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felipe Maldonado, M.D., M.Sc. (+56 2 2978 8221, fmaldonado@uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Cardiac Events (time frame: 7 days after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2024.