Endothelial Dysfunction and Non-cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endothelial Dysfunction During Non-cardiac Surgery and Major Clinical Events

Conditions
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Surgery, Cardiac Death, Stroke, Myocardial Injury

Intervention / Treatment
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* Diagnostic Test: FMD - Troponin measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: FMD - Troponin measurement|Echographic FMD evaluation. Pre and post-operative troponin measurements.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Cardiac Events | Result composed of myocardial infarction, cardiac arrest, and Death | 7 days after surgery | 
| Major Cardiac Events | Result composed of myocardial infarction, cardiac arrest, and Death | 1 month after surgery | 
| Major Cardiac Events | Result composed of myocardial infarction, cardiac arrest, and Death | 3 months after surgery | 
| Major Cardiac Events | Result composed of myocardial infarction, cardiac arrest, and Death | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Injury | Troponin I elevation | 1 day after surgery | 
| Myocardial Injury | Troponin I elevation | 2 days after surgery | 
| Myocardial Injury | Troponin I elevation | 3 days after surgery | 
| Stroke | Stroke incidence after surgery | 7 days after surgery | 
| Stroke | Stroke incidence after surgery | 1 month after surgery | 
| Stroke | Stroke incidence after surgery | 3 months after surgery | 
| Stroke | Stroke incidence after surgery | 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FMD, Flow-Mediated Dilatation, Troponin