Actively Recruiting
Endothelial Dysfunction During Non-cardiac Surgery and Major Clinical Events
Led by University of Chile · Updated on 2024-12-10
200
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
U
University of Chile
Lead Sponsor
A
Agencia Nacional de Investigación y Desarrollo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating endothelial dysfunction, a key factor in cardiovascular disease, and its relationship to cardiovascular events following non-cardiac surgery. This observational study aims to understand how endothelial function affects surgical outcomes by examining patients undergoing non-cardiac surgery. The study will include 200 patients aged 45 or older who are scheduled for non-cardiac surgery. Investigators will measure flow-mediated dilatation (FMD) of the brachial artery using ultrasound before, during, and after surgery. Additionally, blood tests will measure troponin levels before surgery and daily for three days afterward to detect heart injury. Participants will be monitored for major cardiac events and strokes at 7 days, 1 month, 3 months, and 6 months after surgery. Clinical outcomes, including myocardial injury and stroke, will be observed through follow-up visits. The study includes a baseline evaluation, perioperative monitoring, and follow-up assessments to track heart health and surgical effects over time.
CONDITIONS
Brief Title
Endothelial Dysfunction and Non-cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Patients 45 years or older
You will not qualify if you...
- 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
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and up to 3 days after surgery
Participants undergo ultrasound evaluation of the brachial artery flow-mediated dilatation and troponin measurements before, during, and after non-cardiac surgery.
1 visit on surgery day and daily visits for 3 days after surgery
Duration - 6 months after surgery
Participants are observed for major cardiac events and stroke at multiple time points after hospitalization.
3 visits at 1 month, 3 months, and 6 months after surgery
Trial Site Locations
Total: 1 location
1
Hospital Clínico de la Universidad de Chile
Independencia, Santiago Metropolitan, Chile, 8380456
Actively Recruiting
Research Team
F
Felipe Maldonado, M.D., M.Sc.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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