TEAMS (Troponin Elevation After Major Surgery) Study

NCT02146560 | Completed

• 1 other identifier: 13-6378-A
• Study Type: observational
• Target: 267
• Locations: 1 country
• Sites: 1

Brief Summary

Background to main study question: Cardiac complications are a common cause of morbidity after non-cardiac surgery. Patients with perioperative myocardial injury (both MI, and lower levels of cardiac troponin elevation) experience higher short-term and long-term mortality. They are also at substantially increased risk of additional cardiac and non-cardiac complications. It is therefore plausible that myocardial injury adversely affects quality of life. This study will compare postoperative health-related quality of life of patients who did or did not experience perioperative myocardial injury (defined by troponin-I \> 0.07ng/ml) after non-cardiac surgery Study Design: Pilot prospective cohort study (n = 300). Population: Consecutive patients undergoing non-cardiac, non-transplant surgery at UHN. Background to secondary study questions:

1. 1.Clinically based risk stratification tools used in non-cardiac surgery (e.g., Revised Cardiac Risk Index) are of moderate utility and assign patients only to broad risk categories. This study will examine the usefulness of pre-operative biomarkers (BNP, HbA1c, and others) in supporting cardiac risk stratification and will address the question: Is there a set of preoperative criteria that can accurately inform the decision to monitor troponin postoperatively?
2. 2.Intra-operative physiological derangement measured with the Surgical Apgar Score correlates with morbidity and mortality 3-months postoperatively. This study will examine the relationship between the Surgical Apgar Score; continuous non-invasively monitored intraoperative metrics of hemoglobin concentration and occult hypovolemia (Pleth Variability Index) with the Masimo Radical-7 Pulse Co-Oximeter; and the primary and secondary outcomes. This aspect of the study will address the question: Can readily available intraoperative physiological data inform the decision to monitor troponin postoperatively?
3. 3.Quality of Recovery-40 Score evaluates (in the recovery room and at 24 hours postoperatively) the patient's subjective experience of their recovery from surgery. This metric is correlated with quality of life 3-months postop. This study will evaluate correlation between Quality of Recovery-15 Score, a valid and more efficient means of measuring recovery, and the primary and secondary outcomes.
4. 4.Approximately 2/3 of patients who have postoperative myocardial injury are asymptomatic and have no ECG changes. Diagnosis of MI requires biomarker elevation (Troponin \> 0.3ng/ml) plus clinical or ECG or imaging evidence of myocardial injury. Of the latter 3 criteria, 2 are often absent. In selected patients, this study will use trans-thoracic echocardiography, CT coronary angiography, and cardiac MRI to improve diagnostic yield and define those diagnostic modalities that are most useful in the postoperative patient.

Conditions

Perioperative Myocardial Infarction; Disability

Keywords

Surgery; Non-cardiac; Elective; Adult; Patients; Troponin; Myocardial; Injury; Postoperative; Recovery; Outcome

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life

  Health-related quality of life will be evaluated with World Health Organisation Disability Assessment Schedule 2.0

  6 months post-operatively

Secondary Outcomes (3)

• Major Adverse Cardiac Events

  6 months postoperative

• Mortality

  6 months postoperative

• Financial cost

  In-hospital

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective non-cardiac non-transplant surgery

You may qualify if:

• informed written consent
• ASA 2-4
• Age \> 45
• expected length of hospital stay \> 48 hours

You may not qualify if:

• Lack of informed consent
• ASA 5
• expected length of postoperative stay \< 48 hours
• unable to take beta blockers
• unable to take intravenous contrast

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 26, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 5, 2016

Record last verified: 2015-11

Locations

CA (1)