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Myocardial InjuryMINSNCT05188001

Hemodynamics and Myocardial Injury After Non-cardiac Surgery

An observational study of Myocardial Injury and Non-cardiac Surgery, run by University of British Columbia at 1 site in Canada.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The incidence of myocardial injury after non-cardiac surgery (MINS) is approximately 12-15% and is associated with an increased risk of 30-day mortality, 1-year mortality, and 2-year major vascular events. Read more about this study

Who is it for?
Ages 45 years and olderHealthy volunteers can take part
What is being tested?
Not an Interventional Study
How many people
750 participants
Where
1 siteCanada
Study dates
1 Jan 2022to 31 Dec 2022
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 45 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: This study will include patients aged 45 years and older undergoing inpatient noncardiac surgery, who had MINS protocol ordered for postoperative high sensitivity troponin monitoring based on the CCS guidelines from January 2020 to June 2021

Who may be able to join

  • Patients who underwent inpatient noncardiac surgery, who had myocardial injury after non-cardiac surgery (MINS) protocol ordered for postoperative high sensitivity troponin monitoring based on the Canadian Cardiovascular Society (CCS) guidelines
  • Patients who underwent inpatient non-cardiac surgery from January 2020 to June 2021.

Who cannot join

  • Patients who did not have intraoperative and postoperative vital signs
  • Patients who did not have any postoperative troponin measurements
  • Patients who underwent repeat surgery
  • Patients who were readmitted within the first 72 hours postoperatively
  • Patients who had positive troponin on postoperative day 4

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

Official title: Development and Internal Validation of Models Involving Vital Signs to Predict Troponin Level and Myocardial Injury After Non-cardiac Surgery: a Single-centre Retrospective Cohort Study

The incidence of myocardial injury after non-cardiac surgery (MINS) is approximately 12-15% and is associated with an increased risk of 30-day mortality, 1-year mortality, and 2-year major vascular events. Using both traditional longitudinal analysis techniques and novel methods in machine learning, investigators will explore whether intraoperative and postoperative vital signs can enhance MINS surveillance by providing temporal prediction of MINS events.

Read the detailed description

The incidence of myocardial injury after non-cardiac surgery (MINS) is approximately 12-15% and is associated with an increased risk of 30-day mortality, 1-year mortality, and 2-year major vascular events. Since more than 90% of patients with MINS are asymptomatic, routine troponin monitoring is required for detection. The postoperative days 0, 1, and 2 accounts for approximately 40%, 40%, and 10% of MINS, respectively. Presently, the Canadian Cardiovascular Society (CCS) perioperative guidelines recommend patients identified to be at risk according to the Revised Cardiac Risk Index (RCRI) and BNP/NT-pro B-type Natriuretic Peptide (NT-pro BNP) receive daily postoperative troponin monitoring for three days to identify MINS events (5). European and American societies have similar recommendations for troponin monitoring to detect MINS.

Current risk stratification models have multiple limitations. Most importantly, they predict an elevated risk over the postoperative period but cannot pinpoint when MINS may happen in the postoperative course given the patients' changing condition. Moreover, prescription of troponin monitoring is not universal, infrequent and inconsistent troponin monitoring may lead to delayed detection and management, and the rise of troponin is delayed by 3-4 hours from the time of injury.

Retrospective cohort studies show association amongst intraoperative and postoperative derangements in vital signs and MINS. Vital signs are routinely available within the electronic medical record, and may serve as objective predictors (i.e. as opposed to free text and disease names that have higher risks of misclassification and errors).

Using both traditional longitudinal analysis techniques and novel methods in machine learning, investigators will explore whether intraoperative and postoperative vital signs can enhance MINS surveillance by providing temporal prediction of MINS events.

Objectives

  1. To develop and internally validate a model that uses the duration and degree of intraoperative and postoperative hypotension to predict the daily maximum troponin level from postoperative days zero to two, in a high risk population where troponin monitoring was ordered.
  2. To develop and internally validate a model that uses the duration and degree of intraoperative and postoperative hypotension to predict daily probability of MINS or death (binary outcome, according to the 2021 American Heart Association (AHA) definitions from postoperative days zero to two.
  3. To evaluate how different definitions of hypotension affect the primary and secondary models above, and analyze the intraoperative and postoperative hypotension separately to determine whether intraoperative or postoperative hypotension alone are sufficient for prediction.
  4. To explore whether other intraoperative and postoperative vital sign information (heart rate, oxygen saturation, and end-tidal carbon dioxide derangements at various definitions) add predictive value to the primary and secondary models above.
  5. To use machine learning methods to perform exploratory analysis to determine 1) optimal methods for imputation for time series data; 2) visualization of time series data in the setting of prediction; 3) development and internal validation of machine learning models to use the time series data to predict troponin levels; and 4) to determine how many hours earlier than a binary MINS diagnosis were vital signs able to predict a MINS diagnosis (as determined by when in the time series prior to MINS diagnosis that the model achieved various thresholds of predicted probability).

Preoperative laboratory values are collected within 30 days before surgery. Preoperative vitals are collected within 24 hours before surgery. The total duration of subsequent data collection will be from the time of surgery up to postoperative day 3 (since the MINS protocol monitors for 3 days) or hospital discharge or death, whichever occurs first. Since 90% of MINS happen between postoperative days zero and two and the frequency of monitoring would likely decrease by postoperative day 3, investigators will model troponin from postoperative day 0 to postoperative day 2 for the primary analysis to balance utility of the temporal model and prediction data quality.

Being tested
Not an Interventional Study
Keywords
MINS, Troponin
Medical subject headings
Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Not an Interventional StudyOther

    Not an interventional Study

Study groups in NCT05188001
Study groupRoleWhat they receive
Inpatient non-cardiac surgery patientsPatients aged 45 years and older undergoing inpatient non-cardiac surgery who had MINS protocol ordered for postoperative high sensitivity troponin monitoring based on the CCS guidelines from January 2020 to June 2021.
Receives: Other: Not an Interventional Study

What is being measured

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

  1. High Sensitivity Troponin (hsTnT) levels (daily)

    High-sensitivity troponin (hsTnT) level as a continuous outcome (up to and including postoperative day 2)

    Measured: Up to and including postoperative day 2

Secondary outcomes (3)
  1. Myocardial injury after non-cardiac surgery (MINS) (daily)

    Myocardial injury after non-cardiac surgery (MINS), based on the American Heart Association (AHA) definitions up to and including postoperative day 2

    Measured: Up to and including postoperative day 2

  2. High Sensitivity Troponin (hsTnT) levels (daily)

    High-sensitivity troponin (hsTnT) level as a continuous outcome (up to and including postoperative day 3)

    Measured: Up to and including postoperative day 3

  3. Myocardial injury after non-cardiac surgery (MINS) (daily)

    Myocardial injury after non-cardiac surgery (MINS), based on the American Heart Association (AHA) definitions up to and including postoperative day 3

    Measured: Up to and including postoperative day 3

Timeline

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

  1. First posted12 Jan 2022
  2. Study start1 Jan 2022
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (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
Retrospective
Enrolment
750 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05188001
Sponsor's protocol ID
H20-03995
Acronym
MINS
Status last verified
Jan 2022
First submitted
21 Dec 2021
Last updated
12 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Best R, Gao SS, MacDonell SY, Devereaux PJ, Branco P, Gorges M, Flexman AM, Wu L, Ree R, Lo C, Ke JXC. Development and internal validation of models to predict postoperative troponin and myocardial injury after noncardiac surgery by incorporating hypotension as a predictor: single-centre retrospective cohort study. BJA Open. 2026 Jul 28;19:100644. doi: 10.1016/j.bjao.2026.100644. eCollection 2026 Sep.

    PubMed 42569627

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Injury and Non-cardiac Surgery, run by University of British Columbia at 1 site in Canada.

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 2 inclusion and 5 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 12 Jan 2022. 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 Canada. 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?

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?

High Sensitivity Troponin (hsTnT) levels (daily) (time frame: Up to and including postoperative day 2). 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 NCT05188001, 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 12 Jan 2022.

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MINS Clinical Trial NCT05188001 | AzTrials