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NCT Number: NCT05778981

Endothelial Dysfunction and Non-cardiac Surgery

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.

Recruiting

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico de la Universidad de Chile

Independencia, Santiago Metropolitan, 8380456, Chile

Location status: Recruiting

Location contact

Alfredo Parra, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

Catalina Díaz-Papapietro, M.D.

PRINCIPAL_INVESTIGATOR

Diego Varela, Ph.D.

PRINCIPAL_INVESTIGATOR

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

CONTACT

Felipe Medina, Ph.D.

PRINCIPAL_INVESTIGATOR

José I Egaña, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

Marcelo Llancaqueo, M.D.

PRINCIPAL_INVESTIGATOR

Mónica Cáceres, Ph.D.

PRINCIPAL_INVESTIGATOR

Oscar Cerda, Ph.D.

PRINCIPAL_INVESTIGATOR

Roberto González, M.D.

CONTACT

Roberto González, M.D.

PRINCIPAL_INVESTIGATOR

Sergio Bustamante, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FMD - Troponin measurement

Diagnostic Test

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

Primary outcomes

  1. Major Cardiac Events

    Time frame: 7 days after surgery

    Result composed of myocardial infarction, cardiac arrest, and Death

  2. Major Cardiac Events

    Time frame: 1 month after surgery

    Result composed of myocardial infarction, cardiac arrest, and Death

  3. Major Cardiac Events

    Time frame: 3 months after surgery

    Result composed of myocardial infarction, cardiac arrest, and Death

  4. Major Cardiac Events

    Time frame: 6 months after surgery

    Result composed of myocardial infarction, cardiac arrest, and Death

Secondary outcomes

  1. Myocardial Injury

    Time frame: 1 day after surgery

    Troponin I elevation

  2. Myocardial Injury

    Time frame: 2 days after surgery

    Troponin I elevation

  3. Myocardial Injury

    Time frame: 3 days after surgery

    Troponin I elevation

  4. Stroke

    Time frame: 7 days after surgery

    Stroke incidence after surgery

  5. Stroke

    Time frame: 1 month after surgery

    Stroke incidence after surgery

  6. Stroke

    Time frame: 3 months after surgery

    Stroke incidence after surgery

  7. Stroke

    Time frame: 6 months after surgery

    Stroke incidence after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+56 2 2978 8221

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Collaborators

  • Agencia Nacional de Investigación y Desarrollo

Registry information

Official study title

Endothelial Dysfunction During Non-cardiac Surgery and Major Clinical Events

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 22, 2023
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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