Endothelial Dysfunction and Non-cardiac Surgery

Endothelial Dysfunction During Non-cardiac Surgery and Major Clinical Events

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Myocardial Injury; Surgery; Cardiac Death
• Intervention / Treatment: Diagnostic test: FMD - Troponin measurement

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Felipe Maldonado, M.D., M.Sc.; Phone Number: +56 2 2978 8221; Email: fmaldonado@uchile.cl

Study Locations

• Chile
  • Santiago
    • Independencia, Santiago, Chile, 8380456
      • Recruiting
      • Hospital Clinico de la Universidad de Chile
      • Contact: Felipe Maldonado, M.D., M.Sc.
      • Contact: Roberto González, M.D.
      • Principal Investigator: Mónica Cáceres, Ph.D.
      • Principal Investigator: Oscar Cerda, Ph.D.
      • Principal Investigator: Catalina Díaz-Papapietro, M.D.
      • Principal Investigator: Roberto González, M.D.
      • Principal Investigator: Diego Varela, Ph.D.
      • Principal Investigator: Felipe Medina, Ph.D.
      • Principal Investigator: Sergio Bustamante, M.D.
      • Principal Investigator: José I Egaña, M.D., Ph.D.
      • Principal Investigator: Marcelo Llancaqueo, M.D.
      • Principal Investigator: Alfredo Parra, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for non-cardiac surgery of 45 years old and older.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Chile
• Collaborators: Agencia Nacional de Investigación y Desarrollo
• Investigators: Study Chair: Felipe Maldonado||, M.D.,M.Sc., Hospital Clinico de la Universidad de Chile

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Troponin; FMD; Flow-Mediated Dilatation
• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: OAIC 1316/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No