Clinical trial NCT05778981: Endothelial Dysfunction and Non-cardiac Surgery
Official title: Endothelial Dysfunction During Non-cardiac Surgery and Major Clinical Events
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery
Cardiac Death
Stroke
Myocardial Injury
Keywords: FMD
Flow-Mediated Dilatation
Troponin
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Agencia Nacional de Investigación y Desarrollo
First posted: 2023-03-22
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for non-cardiac surgery of 45 years old and older.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major Cardiac Events
timeFrame: 7 days after surgery
measure: Major Cardiac Events
timeFrame: 1 month after surgery
measure: Major Cardiac Events
timeFrame: 3 months after surgery
measure: Major Cardiac Events
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Myocardial Injury
timeFrame: 1 day after surgery
measure: Myocardial Injury
timeFrame: 2 days after surgery
measure: Myocardial Injury
timeFrame: 3 days after surgery
measure: Stroke
timeFrame: 7 days after surgery
measure: Stroke
timeFrame: 1 month after surgery
measure: Stroke
timeFrame: 3 months after surgery
measure: Stroke
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Independencia
country: Chile
facility: Hospital Clínico de la Universidad de Chile
state: Santiago
Study officials:
affiliation: Hospital Clinico de la Universidad de Chile
name: Felipe Maldonado||, M.D.,M.Sc.
role: STUDY_CHAIR
References: