NCT02344771

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

January 13, 2015

Last Update Submit

February 14, 2021

Conditions

Myocardial Injury

Keywords

Endothelial dysfunctionGeneral SurgeryPerioperative Care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • Biomarkers of endothelial glycocalyx degradation (syndecan-1, atrial natriuretic peptide)

    before surgery, 4 hours postoperatively and daily assessments on day 1-4 after surgery.

  • Plasma cardiac troponin I

    before surgery and one daily assessment on day 1-4 after surgery.

Interventions

Elective colon cancer surgeryPROCEDURE

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A population of patients with colon cancer undergoing elective cancer surgery.

You may qualify if:

  • Patients scheduled for elective colon cancer surgery

You may not qualify if:

  • Not capable of giving informed consent after oral and written information
  • Previously included in the trial
  • Surgery within 7 days of the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Roskilde Hospital

Roskilde, 4000, Denmark

Location

Related Publications (1)

  • Ekeloef S, Larsen MH, Schou-Pedersen AM, Lykkesfeldt J, Rosenberg J, Gogenur I. Endothelial dysfunction in the early postoperative period after major colon cancer surgery. Br J Anaesth. 2017 Feb;118(2):200-206. doi: 10.1093/bja/aew410.

    PMID: 28100523DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

Study Officials

  • Sarah E Busch, MD

    Department of Surgery, Koge University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.d. student

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 26, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations

DK(1)