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Endothelial Dysfunction and Non-cardiac Surgery

Endothelial Dysfunction During Non-cardiac Surgery and Major Clinical Events

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05778981
Enrollment
200
Registered
2023-03-22
Start date
2023-03-25
Completion date
2025-12-01
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Death, Myocardial Injury, Stroke, Surgery

Keywords

FMD, Flow-Mediated Dilatation, Troponin

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTFMD - Troponin measurement

Echographic FMD evaluation. Pre and post-operative troponin measurements.

Sponsors

Agencia Nacional de Investigación y Desarrollo
CollaboratorOTHER
University of Chile
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Signed informed consent * Patients 45 years or older

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Major Cardiac Events7 days after surgeryResult composed of myocardial infarction, cardiac arrest, and Death

Secondary

MeasureTime frameDescription
Myocardial Injury1 day after surgeryTroponin I elevation
Stroke7 days after surgeryStroke incidence after surgery

Countries

Chile

Contacts

Primary ContactFelipe Maldonado, M.D., M.Sc.
fmaldonado@uchile.cl+56 2 2978 8221

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026