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| Name | Class |
|---|---|
| Agencia Nacional de Investigación y Desarrollo | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMD - Troponin measurement | Diagnostic Test | Echographic FMD evaluation. Pre and post-operative troponin measurements. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Injury | Troponin I elevation | 1 day after surgery |
| Myocardial Injury | Troponin I elevation | 2 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for non-cardiac surgery of 45 years old and older.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Felipe Maldonado, M.D., M.Sc. | Contact | +56 2 2978 8221 | fmaldonado@uchile.cl |
| Name | Affiliation | Role |
|---|---|---|
| Felipe Maldonado||, M.D.,M.Sc. | Hospital Clinico de la Universidad de Chile | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico de la Universidad de Chile | Recruiting | Independencia | Santiago Metropolitan | 8380456 | Chile |
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| ID | Term |
|---|---|
| D003643 | Death |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| 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 |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |