Endothelial Dysfunction and Non-cardiac Surgery

NCT ID: NCT05778981

Last Updated: 2024-12-10

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-25

Study Completion Date

2025-12-01

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.

Conditions

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Surgery Cardiac Death Stroke Myocardial Injury

Keywords

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FMD Flow-Mediated Dilatation Troponin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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FMD - Troponin measurement

Echographic FMD evaluation. Pre and post-operative troponin measurements.

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agencia Nacional de Investigación y Desarrollo

OTHER

Sponsor Role collaborator

University of Chile

OTHER

Sponsor Role lead

Responsible Party

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Felipe Andrés Maldonado Caniulao

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Felipe Maldonado, M.D., M.Sc.

Role: CONTACT

Phone: +56 2 2978 8221

Email: [email protected]

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