Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02344771
Other study ID # SBpoetry
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
See also
  Status Clinical Trial Phase
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Completed NCT01688648 - Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft N/A
Completed NCT04794062 - Myocardial Injury and Quality of Life After COVID-19
Recruiting NCT04750616 - NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial Phase 2
Recruiting NCT04615871 - Semaglutide to Reduce Myocardial Injury in PATIents With COVID-19 Phase 2
Withdrawn NCT04139655 - Colchicine Prevents Myocardial Injury After Non-Cardiac Surgery Pilot Study N/A
Completed NCT05691764 - Effect of Cyclosporine and Remote Ischemic Preconditioning in Reperfusion Ischemia Injury on Tetralogy Fallot Patients With Correction Surgery N/A
Completed NCT04436016 - PeRiOperaTivE CardioproTection With Ivabradine in Non-cardiac Surgery Phase 4
Completed NCT05748691 - Switching From Cardiac Troponin I to T
Completed NCT03338504 - Determining the Mechanism of Myocardial Injury and Role of Coronary Disease in Type 2 Myocardial Infarction
Recruiting NCT03013634 - Protective Effects of Dexmedetomidine on Myocardial Injury During Liver Transplantation N/A
Completed NCT00007358 - Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns With Lupus N/A
Recruiting NCT05714618 - MR Evidence of Cardiac Inflammation Post-Stroke
Recruiting NCT04624503 - Prognostic and Clinical Impact of Cardiovascular Involvement in Patients With COVID-19
Active, not recruiting NCT03339180 - Cardiac Injury in Patients With Influenza
Completed NCT03010839 - Cardiopulmonary Protective Effects of Modified Remote Ischaemic Preconditioning in Mitral Valve Replacement Surgery N/A
Recruiting NCT04743765 - HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial N/A
Enrolling by invitation NCT03253835 - Cardiac Blood Flow Patterns Associated With Left Ventricular Myocardial Damage
Completed NCT00817791 - Preconditioning With Hyperbaric Oxygen in Cardiovascular Surgery N/A
Completed NCT04149314 - The "Hypotension Prediction Index" in Patients Undergoing Lung Surgery N/A