Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05778981
Status:
RECRUITING
Last Update Posted:
2023-03-28
First Post:
2023-02-21
Brief Title:
Endothelial Dysfunction and Non-cardiac Surgery
Sponsor:
University of Chile
Organization:
University of Chile
Study Overview
Official Title:
Endothelial Dysfunction During Non-cardiac Surgery and Major Clinical Events
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
This research aims to study endothelial function and its association with cardiovascular events
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None