Perioperative Endothelial Dysfunction

Myocardial Injury Clinical Trial

Official title:

Perioperative Endothelial Dysfunction in Patients Undergoing Non-cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344771
• Other study ID #: SBpoetry
• Status: Completed
• Start date: March 2015
• Est. completion date: June 2015

Study information

• Verified date: February 2021
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

More than one in 100 otherwise healthy patients undergoing non-cardiac surgery will die within 30 days post-operatively, and of these patients 45% will die from vascular causes such as myocardial infarction. The pathogenesis of perioperative myocardial infarction is complex and to date not fully elucidated. The physiological stress response associated with the surgical procedure is believed to be central in the development of perioperative cardiovascular complications. Surgery initiates systemic inflammation, hypercoagulability and increases the production of catecholamines and cortisol. These drastic systemic changes lead to a state of myocardial oxygen supply-demand mismatch, which added to acute endothelial dysfunction and ruptures of vulnerable plaques, may result in myocardial injury.

The endothelium is a regulator of vascular homeostasis, vascular tone and structure and exerts anticoagulant, antiplatelet and fibrinolytic properties. Endothelial dysfunction is characterized by a decreased vascular bioavailability of nitric oxide probably due to an increased degradation of nitric oxide via its interaction with locally produced reactive oxygen species. No clinical studies have investigated whether peri- and postoperative endothelial dysfunction is associated with an increased risk of perioperative myocardial injury. Endothelial dysfunction may be a key element in the development of perioperative myocardial injury.

The aim of this observational clinical study is to closely examine the endothelial function and its dynamics in the early postoperative period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for elective colon cancer surgery

Exclusion Criteria:

• Not capable of giving informed consent after oral and written information

• Previously included in the trial

• Surgery within 7 days of the trial

Related Conditions & MeSH terms

• Myocardial Injury

Intervention

Procedure:
• Elective colon cancer surgery

Locations

Country	Name	City	State
Denmark	Department of Surgery, Roskilde Hospital	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline endothelial function (reactive hyperemia index) at 4 days postoperatively	The reactive hyperemia index is assessed non-invasively by the EndoPat system.	baseline before operation, 4 hours postoperatively and daily assessments day 1-4 after surgery.
Secondary	Biomarkers of endothelial function: plasma arginine, plasma asymmetric dimethylarginine and plasma tetrahydrobiopterin		before surgery, 4 hours postoperatively and daily assessments on day 1-4 after surgery
Secondary	Biomarkers of endothelial glycocalyx degradation (syndecan-1, atrial natriuretic peptide)		before surgery, 4 hours postoperatively and daily assessments on day 1-4 after surgery.
Secondary	Plasma cardiac troponin I		before surgery and one daily assessment on day 1-4 after surgery.