NCT03408522

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.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
2 countries

3 active sites

Status
unknown

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 15, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

January 29, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

1.4 years

First QC Date

January 15, 2018

Last Update Submit

January 14, 2019

Conditions

Perioperative Myocardial InfarctionDisabilityPerioperative/Postoperative Complications

Outcome Measures

Primary Outcomes (1)

  • Disability

    Disability is expressed by the World Health Organization Disability Assessment Score 2.0 (WHODAS 2.0), which is based on difficulties experienced by the respondent in different functional domains including, cognition, mobility, self-care, getting along, life activities and participation during the previous 30 days. Disability is defined as a decrement in each functioning domain corresponding to score between 0% and 100%, in which no disability stands for a score of 0% and full disability represents a score of 100%, including death.

    6 months after surgery

Secondary Outcomes (7)

  • Disability free survival

    6 months after surgery

  • Major adverse cardiovascular event (MACE)

    1 week after surgery

  • Noncardiac major adverse postoperative events (MAPE)

    1 week after surgery

  • Length of hospital stay

    1 week after surgery

  • All-cause mortality

    1 week after surgery

  • +2 more secondary outcomes

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 60 years or older, undergoing major elective non-cardiac surgery under general or spinal anesthesia with an expected hospital admittance of at least 24 hours.

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

NOT YET RECRUITING

UMC Utrecht

Utrecht, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wilton A van Klei, MD PhD

    prof. dr.

    PRINCIPAL INVESTIGATOR

  • W. Scott Beattie, MD PhD FRCPC

    prof. dr.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wilton A van Klei, MD, PhD

CONTACT

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

Lisette M Vernooij, Msc

CONTACT

l.m.vernooij@umcutrecht.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

January 15, 2018

First Posted

January 24, 2018

Study Start

January 29, 2018

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations

CA(2)NL(1)