Myocardial InjuryNCT02344771
Perioperative Endothelial Dysfunction
An observational study of Myocardial Injury, run by Zealand University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Myocardial Injury
- What is being tested?
- Elective colon cancer surgery
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A population of patients with colon cancer undergoing elective cancer surgery.
Who may be able to join
- Patients scheduled for elective colon cancer surgery
Who cannot join
- Not capable of giving informed consent after oral and written information
- Previously included in the trial
- Surgery within 7 days of the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Endothelial Dysfunction in Patients Undergoing Non-cardiac Surgery
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.
- Conditions
- Myocardial Injury
- Being tested
- Elective colon cancer surgery
- Keywords
- Endothelial dysfunction, General Surgery, Perioperative Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective colon cancer surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline endothelial function (reactive hyperemia index) at 4 days postoperatively
The reactive hyperemia index is assessed non-invasively by the EndoPat system.
Measured: 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
Measured: before surgery, 4 hours postoperatively and daily assessments on day 1-4 after surgery
Biomarkers of endothelial glycocalyx degradation (syndecan-1, atrial natriuretic peptide)
Measured: before surgery, 4 hours postoperatively and daily assessments on day 1-4 after surgery.
Plasma cardiac troponin I
Measured: before surgery and one daily assessment on day 1-4 after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Victoria Ekeløf Busch, Zealand University Hospital
- Investigators
- Sarah E Busch, MD, Principal investigator, Department of Surgery, Koge University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344771
- Sponsor's protocol ID
- SBpoetry
- Status last verified
- Feb 2021
- First submitted
- 13 Jan 2015
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28100523
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Endothelial Dysfunction in Patients Undergoing Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT02344771
- Acronym / sponsor ID
- SBpoetry
- Conditions
- Myocardial Injury
- Keywords
- Endothelial dysfunction, General Surgery, Perioperative Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A population of patients with colon cancer undergoing elective cancer surgery.
Key inclusion criteria (1 listed)
- Patients scheduled for elective colon cancer surgery
Key exclusion criteria (3 listed)
- Not capable of giving informed consent after oral and written information
- Previously included in the trial
- Surgery within 7 days of the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective colon cancer surgery | Procedure or surgery | – |
Primary outcome
Change from baseline endothelial function (reactive hyperemia index) at 4 days postoperatively
Time frame: baseline before operation, 4 hours postoperatively and daily assessments day 1-4 after surgery.
The reactive hyperemia index is assessed non-invasively by the EndoPat system.
3 secondary outcomes
Biomarkers of endothelial function: plasma arginine, plasma asymmetric dimethylarginine and plasma tetrahydrobiopterin
Time frame: before surgery, 4 hours postoperatively and daily assessments on day 1-4 after surgery
Biomarkers of endothelial glycocalyx degradation (syndecan-1, atrial natriuretic peptide)
Time frame: before surgery, 4 hours postoperatively and daily assessments on day 1-4 after surgery.
Plasma cardiac troponin I
Time frame: before surgery and one daily assessment on day 1-4 after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Derived from this study: PubMed 28100523Ekeloef 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah E Busch, MD principal investigator
Department of Surgery, Koge University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Injury, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline endothelial function (reactive hyperemia index) at 4 days postoperatively (time frame: baseline before operation, 4 hours postoperatively and daily assessments day 1-4 after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02344771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.