Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2023-03-25
2025-12-01
Brief Summary
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This research aims to study endothelial function and its association with cardiovascular events.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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FMD - Troponin measurement
Echographic FMD evaluation. Pre and post-operative troponin measurements.
Eligibility Criteria
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Inclusion Criteria
* Patients 45 years or older
Exclusion Criteria
* 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
45 Years
ALL
Yes
Sponsors
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Agencia Nacional de Investigación y Desarrollo
OTHER
University of Chile
OTHER
Responsible Party
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Felipe Andrés Maldonado Caniulao
Principal Investigator
Principal Investigators
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Felipe Maldonado||, M.D.,M.Sc.
Role: STUDY_CHAIR
Hospital Clinico de la Universidad de Chile
Locations
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Hospital Clínico de la Universidad de Chile
Independencia, Santiago Metropolitan, Chile
Countries
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Central Contacts
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Facility Contacts
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Felipe Maldonado, M.D., M.Sc.
Role: primary
Roberto González, M.D.
Role: backup
Other Identifiers
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OAIC 1316/22
Identifier Type: -
Identifier Source: org_study_id