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AzTrials

Perioperative Myocardial InfarctionTEAMS2NCT03408522

Troponin Elevation After Major Noncardiac Surgery 2

An observational study of Perioperative Myocardial Infarction and Disability, run by UMC Utrecht at 3 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
How many people
1,000 participants
Where
3 sitesin 2 countries
Study dates
29 Jan 2018to 31 Dec 2019
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • ≥ 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 2 countries.

Wilton A van Klei, MD, PhD contact

+3188 75 59475

w.a.vanklei@umcutrecht.nl

Lisette M Vernooij, Msc contact

l.m.vernooij@umcutrecht.nl

3 sites in 2 countries

Canada2 sites, 2 recruiting

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

    W. Scott Beattie, MD PhD FRCPC

    Recruiting

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

    W. Scott Beattie, MD PhD FRCPC

    Not yet recruiting

Other trials in Canada

Netherlands1 site, 1 recruiting

  • UMC Utrecht

    Utrecht

    Wilton A van Klei, MD, PhD

    Recruiting

Other trials in Netherlands

About this study

Official title: Clinical Characteristics and Functional Outcomes of Postoperative Myocardial Injury: A Prospective Cohort Study - Troponin Elevation After Major Noncardiac Surgery 2

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.

Medical subject headings
Postoperative Complications

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months after surgery

Secondary outcomes (7)

  1. Disability free survival

    Disability free survival is defined as being alive with a WHODAS 2.0 score ≤ 25% and no increase of the pre-operative score ≥ 25% at 6 months after surgery.

    Measured: 6 months after surgery

  2. Major adverse cardiovascular event (MACE)

    MACE is defined as a composite outcome consisting of cardiovascular death, non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal ventricular fibrillation, ventricular arrhythmia with hemodynamic compromise, atrial fibrillation requiring cardioversion, pulmonary embolism, stroke

    Measured: 1 week after surgery

  3. Noncardiac major adverse postoperative events (MAPE)

    Noncardiac MAPE is a composite outcome consisting of respiratory failure (including pneumonia and hypoxia or hypercapnia leading to ICU admission for respiratory support), sepsis, renal failure, unplanned ICU admission, unplanned medium care admission, reoperation

    Measured: 1 week after surgery

  4. Length of hospital stay

    the number of days from the end of surgery until day of discharge

    Measured: 1 week after surgery

  5. All-cause mortality

    Measured: 1 week after surgery

  6. Major adverse cardiovascular event (MACE)

    Measured: 6 months after surgery

  7. All-cause mortality

    Measured: 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2018
  2. Study start29 Jan 2018
  3. Primary completion30 Jun 2019 (estimated)
  4. Study completion31 Dec 2019 (estimated)

Resources

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
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03408522
Sponsor's protocol ID
TEAMS2
Acronym
TEAMS2
Status last verified
Jan 2019
First submitted
15 Jan 2018
Last updated
16 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Vernooij LM, van Waes JAR, Grobben RB, van Lier F, Feng S, Machina M, McKenny M, Nathoe HM, Wijeysundera DN, van Klei WA, Beattie WS. Postoperative myocardial injury phenotypes and self-reported disability in patients undergoing noncardiac surgery: a multicentre observational study. Br J Anaesth. 2024 Jan;132(1):35-44. doi: 10.1016/j.bja.2023.10.012. Epub 2023 Dec 5.

    PubMed 38057252

Questions about this trial

What is this clinical trial studying?

An observational study of Perioperative Myocardial Infarction and Disability, run by UMC Utrecht at 3 sites in 2 countries.

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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada, Netherlands. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wilton A van Klei, MD, PhD (+3188 75 59475, w.a.vanklei@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disability (time frame: 6 months 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 NCT03408522, 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 Jan 2019.

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