Recruiting

Observational Study

Sponsor:

UMC Utrecht

Code:

NCT03408522

Conditions

Perioperative Myocardial Infarction

Disability

Perioperative/Postoperative Complications

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Major adverse cardiac events (MACE) are a leading cause of mortality in patients undergoing noncardiac surgery. Patients with perioperative myocardial injury (PMI), defined as either myocardial infarction and lower elevations in cardiac troponin, are also at substantially increased risk of additional cardiac and noncardiac complications. Accordingly, it is plausible to assume that PMI negatively affects quality of life in terms of disability. The aim of this study is to investigate and compare the independent prognostic effects of the different PMI phenotypes (myocardial infarction and non-infarct troponin elevations) and noncardiac complications on disability in patients undergoing elective noncardiac surgery.

Conditions

Perioperative Myocardial Infarction

Disability

Perioperative/Postoperative Complications

Study ID

NCT03408522

Start date

Jan 29, 2018

Status verified date

Jan, 2019

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Jun 30, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥ 60 years old;
  • Major noncardiac surgery defined as all noncardiac surgical procedures requiring an expected hospital stay of at least 24 hours;
  • Elective surgery, defined as surgery that that has been preceded by a preoperative consultation at the anesthesia preoperative screening outpatient clinic.

Exclusion Criteria:

  • Patients unable to fully comply to study needs (e.g. legally incapable patients or patients unable to communicate in Dutch or English).
  • Patients with an American Society of Anesthesiologists (ASA) Physical status 5

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Disability [ Time Frame: 6 months after surgery ]

Central Contacts and Locations

Central contacts

Wilton A van Klei, MD, PhD

+3188 75 59475w.a.vanklei@umcutrecht.nl

Lisette M Vernooij, Msc

l.m.vernooij@umcutrecht.nl

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

More Information

Sponsor

UMC Utrecht

Last update posted

Jan 16, 2019

Last verified

Jan, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UMC Utrecht on 2019-01-16.