Endothelial Dysfunction and Non-cardiac Surgery

Stroke Clinical Trial

Official title:

Endothelial Dysfunction During Non-cardiac Surgery and Major Clinical Events

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778981
• Other study ID #: OAIC 1316/22
• Status: Recruiting
• Start date: March 25, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2023
• Source: University of Chile
• Contact: Felipe Maldonado, M.D., M.Sc.
• Phone: +56 2 2978 8221
• Email: fmaldonado[@]uchile.cl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Death
• Death
• Myocardial Injury
• Stroke
• Surgery

Intervention

Diagnostic Test:
• FMD - Troponin measurement
Echographic FMD evaluation. Pre and post-operative troponin measurements.

Locations

Country	Name	City	State
Chile	Hospital Clínico de la Universidad de Chile	Independencia	Santiago

Sponsors (2)

Lead Sponsor	Collaborator
University of Chile	Agencia Nacional de Investigación y Desarrollo

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Cardiac Events	Result composed of myocardial infarction, cardiac arrest, and Death	7 days after surgery
Primary	Major Cardiac Events	Result composed of myocardial infarction, cardiac arrest, and Death	1 month after surgery
Primary	Major Cardiac Events	Result composed of myocardial infarction, cardiac arrest, and Death	3 months after surgery
Primary	Major Cardiac Events	Result composed of myocardial infarction, cardiac arrest, and Death	6 months after surgery
Secondary	Myocardial Injury	Troponin I elevation	1 day after surgery
Secondary	Myocardial Injury	Troponin I elevation	2 days after surgery
Secondary	Myocardial Injury	Troponin I elevation	3 days after surgery
Secondary	Stroke	Stroke incidence after surgery	7 days after surgery
Secondary	Stroke	Stroke incidence after surgery	1 month after surgery
Secondary	Stroke	Stroke incidence after surgery	3 months after surgery
Secondary	Stroke	Stroke incidence after surgery	6 months after surgery