Hemodynamics and Myocardial Injury After Non-cardiac Surgery

NCT05188001 | Unknown

• 1 other identifier: H20-03995
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Myocardial Injury; Non-cardiac Surgery; Complication,Postoperative; High-sensitivity Troponin

Keywords

MINS; Troponin

Outcome Measures

Primary Outcomes (1)

• High Sensitivity Troponin (hsTnT) levels (daily)

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

  Up to and including postoperative day 2

Secondary Outcomes (3)

• Myocardial injury after non-cardiac surgery (MINS) (daily)

  Up to and including postoperative day 2

• High Sensitivity Troponin (hsTnT) levels (daily)

  Up to and including postoperative day 3

• Myocardial injury after non-cardiac surgery (MINS) (daily)

  Up to and including postoperative day 3

Study Arms (1)

Inpatient non-cardiac surgery patients

Patients 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.

Other: Not an Interventional Study

Interventions

Not an Interventional Study OTHER

Not an interventional Study

Inpatient non-cardiac surgery patients

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Diana Su-Yin MacDonell, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 12, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 12, 2022

Record last verified: 2022-01

Locations

CA (1)