Endothelial Dysfunction and Non-cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FMD - Troponin measurement.
- Who it may be relevant to
- Registry conditions: Surgery, Cardiac Death, Stroke, Myocardial Injury. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Chile
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Endothelial Dysfunction During Non-cardiac Surgery and Major Clinical Events
Overview
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 test FMD - Troponin measurement
Echographic FMD evaluation. Pre and post-operative troponin measurements.
Primary outcome measures
- Major Cardiac Events [Time frame: 7 days after surgery]
- Major Cardiac Events [Time frame: 1 month after surgery]
- Major Cardiac Events [Time frame: 3 months after surgery]
- Major Cardiac Events [Time frame: 6 months after surgery]
Secondary outcome measures (7)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Chile · 1 center
- Hospital Clínico de la Universidad de Chile — Independencia
Identifiers
NCT: NCT05778981 · OAIC 1316/22