Disability Clinical Trial
— TEAMSOfficial title:
Clinical Characteristics and Functional Outcomes of Postoperative Myocardial Injury: a Prospective Cohort Study. TEAMS (Troponin Elevation After Major Surgery) Study
Verified date | November 2015 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Observational |
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. 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. 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. 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. 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.
Rationale:
Postoperative myocardial injury may negatively impact health-related quality of life.
Affected patients may experience higher levels of postoperative dependency. This possibility
has implications for patient rehabilitation, provincial and personal healthcare costs, as
well as patients' physical, emotional and mental well-being and relationships. The public
health dimension of this problem could therefore be significant. In addition, an incomplete
understanding exists of how individual patient cardiac risk factors, in combination with the
perioperative environment, result in myocardial injury. The diagnostic investigations that
are most useful in this setting have not yet been clearly defined. Patients who fail to be
rescued after experiencing postoperative complications (as distinct from failure to avoid
experiencing the complication in the first instance) plays a central role in postoperative
mortality. Early recognition of such patients is therefore crucial. By prospectively
observing a cohort of high-risk surgical patients, this study will provide insight into how
these factors interact. This will allow us to better characterize the potential predictors
and features of postoperative myocardial injury. We hope that our findings will aid in the
identification of patient characteristics associated with increased risks of postoperative
myocardial injury, thus helping to direct diagnosis, early treatment and rescue. This study
will thus potentially yield important data that will positively impact future patient care
and the rational use of healthcare resources.
Status | Completed |
Enrollment | 267 |
Est. completion date | August 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years and older |
Eligibility |
Inclusion Criteria: - informed written consent - ASA 2-4 - Age > 45 - expected length of hospital stay > 48 hours Exclusion Criteria: - Lack of informed consent - ASA 5 - expected length of postoperative stay < 48 hours - unable to take beta blockers - unable to take intravenous contrast |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Major Adverse Cardiac Events | Myocardial Infarction (Type 1 or 2) Malignant ventricular arrhythmia (including cardiac arrest) Re-vascularisation Cardiac mortality | 6 months postoperative | No |
Secondary | Mortality | All-cause mortality | 6 months postoperative | No |
Secondary | Financial cost | Healthcare-associated costs of providing care for individual patients in this study | In-hospital | No |
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