Endothelial Dysfunction and Non-cardiac Surgery

• Sponsor: University of Chile (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05778981
• Collaborator: Agencia Nacional de Investigación y Desarrollo (Other)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 20.3
• Patients Per Site Per Month: 9.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Surgery; Cardiac Death; Stroke; Myocardial Injury	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 Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Endothelial Dysfunction During Non-cardiac Surgery and Major Clinical Events
• Actual Study Start Date: Mar 25, 2023
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Outcome Measures

Primary Outcome Measures

1. Major Cardiac Events [7 days after surgery]

   Result composed of myocardial infarction, cardiac arrest, and Death

2. Major Cardiac Events [1 month after surgery]

   Result composed of myocardial infarction, cardiac arrest, and Death

3. Major Cardiac Events [3 months after surgery]

   Result composed of myocardial infarction, cardiac arrest, and Death

4. Major Cardiac Events [6 months after surgery]

   Result composed of myocardial infarction, cardiac arrest, and Death

Secondary Outcome Measures

1. Myocardial Injury [1 day after surgery]

   Troponin I elevation

2. Myocardial Injury [2 days after surgery]

   Troponin I elevation

3. Myocardial Injury [3 days after surgery]

   Troponin I elevation

4. Stroke [7 days after surgery]

   Stroke incidence after surgery

5. Stroke [1 month after surgery]

   Stroke incidence after surgery

6. Stroke [3 months after surgery]

   Stroke incidence after surgery

7. Stroke [6 months after surgery]

   Stroke incidence after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clínico de la Universidad de Chile	Independencia	Santiago	Chile	8380456

Sponsors and Collaborators

• University of Chile
• Agencia Nacional de Investigación y Desarrollo

Investigators

• Study Chair: Felipe Maldonado||, M.D.,M.Sc., Hospital Clinico de la Universidad de Chile

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Felipe Andrés Maldonado Caniulao, Principal Investigator, University of Chile
• ClinicalTrials.gov Identifier: NCT05778981
• Other Study ID Numbers: OAIC 1316/22
• First Posted: Mar 22, 2023
• Last Update Posted: Mar 28, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Felipe Andrés Maldonado Caniulao, Principal Investigator, University of Chile: FMD; Flow-Mediated Dilatation; Troponin
• Additional relevant MeSH terms: Death

Study Results

No Results Posted as of Mar 28, 2023