Primary objective To investigate and compare the independent prognostic effects of the different PMI phenotypes (myocardial infarction and noninfarct troponin elevation) and noncardiac MAPE on disability in patients undergoing elective noncardiac…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disability is expressed in terms of the WHODAS 2.0 which is based on different
functional domains, including cognition, mobility, self-care, getting along,
life activities and participation.
Secondary outcome
- Disability free survival is defined as being alive with a WHODAS 2.0 score <=
25% and no increase of the preoperative score >= 25% at 6 months after surgery.
- An in-hospital major adverse postoperative events (MAPE), which could be
distinguished in:
o Major adverse cardiac event (MACE), which is defined as the composite
endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal
cardiac arrest, non-fatal ventricular fibrillation, non-fatal ventricular
hemodynamic compromise and atrial fibrillation requiring cardioversion.
o Noncardiac MAPE, which is defined as a composite outcome consisting of
respiratory disorders (including pneumonia and respiratory failure), pulmonary
embolism, sepsis and/or systemic inflammatory response syndrome (SIRS), renal
failure, reoperation and unplanned ICU admission.
- In hospital all-cause mortality
- Length of hospital stay
- 6-month MACE
- 6-month all-cause mortality
Background summary
Patients undergoing major noncardiac surgery may experience major adverse
postoperative events (MAPE), which lead to mortality and morbidity. Such
complications are hard to diagnose, as typical symptoms are often not present
in most often postoperative patients (e.g., chest pain may be masked by pain
medication).
Routinely measuring cardiac troponins during the perioperative period is an
accurate method to confirm diagnosis of postoperative myocardial injury (PMI).
In patients aged > 60 years undergoing intermediate or high risk noncardiac
surgery, PMI occurs in 15% of the patients. Approximately one third of them
develops an often symptomless myocardial infarction. However, PMI is also
associated with other cardiac and noncardiac pathologies including heart
failure, arrhythmias, pulmonary embolism, sepsis and renal failure. Therefore,
we consider PMI as either myocardial infarction or noninfarct troponin
elevation (NITE). Currently, the etiology and long term effects of PMI on
disability are unknown. Differentiation of patients with PMI in the appropriate
disease entity will hopefully contribute to more suitable treatment and
prevention of major complications.
The aim of this study is to investigate and compare the independent prognostic
effects of the different PMI phenotypes (myocardial infarction and NITE) and
noncardiac MAPE on disability. We will be diagnosing the differing PMI
phenotypes using clinical evaluation and biomarkers.
Study objective
Primary objective
To investigate and compare the independent prognostic effects of the different
PMI phenotypes (myocardial infarction and noninfarct troponin elevation) and
noncardiac MAPE on disability in patients undergoing elective noncardiac
surgery.
Secondary objectives
1. To investigate and compare the independent prognostic effect of the
different PMI phenotypes (myocardial infarction and noninfarct troponin
elevation) and noncardiac MAPE on disability free survival in patients
undergoing elective noncardiac surgery.
2. To examine whether (combinations of) perioperatively measured biomarkers are
associated with in-hospital MAPE in patients undergoing elective noncardiac
surgery. MAPE are divided in different subtypes, including:
a. MACE, which is defined as the composite endpoint of cardiovascular death,
non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal
ventricular fibrillation, ventricular hemodynamic compromise, atrial
fibrillation requiring cardioversion, pulmonary embolism and stroke.
b. Noncardiac MAPE including sepsis, renal failure, unexpected intensive care
unit (ICU) admission and respiratory disorders.
c. All-cause mortality
3. To examine whether (combinations of) perioperatively measured biomarkers are
associated with 6-month MACE and all-cause mortality in patients undergoing
elective noncardiac surgery.
4. To assess the added value of the perioperatively measured biomarkers on top
of the currently used Revised Cardiac Risk Index (RCRI) to predict MACE after
noncardiac surgery.
5. To externally validate existing prediction models to predict postoperative
outcomes in patients undergoing noncardiac surgery.
Study design
This prospective observational cohort study includes patients, aged 60 years
and older, undergoing elective intermediate or high risk noncardiac surgery
under spinal or general anesthesia with an expected postoperative hospital
admittance of at least 24h. All patients are required to visit the
preanesthesia outpatient clinic for preoperative consultation. In addition to
care as usual, extra blood samples will be taken preoperatively and
postoperatively up to three days after surgery to determine the following
biomarkers: high sensitive troponin, brain natriuretic protein, C-reactive
protein, creatinine and hemoglobin. At postoperative day 1, extra to routine
care noninvasive imaging (i.e. electrocardiography and if possible a
transthoracic echography) will be performed. Preoperatively measured
biomarkers are considered baseline measurements. Biomarker values will be
blinded from treating physicians in case this particular biomarker was not
measured in routine care. In-hospital MAPE will be monitored including cardiac
events, respiratory failure, pulmonary embolism, sepsis, renal failure and
mortality. In addition, patients will be asked to fill out the WHODAS 2.0
questionnaire preoperatively and 6 months after their surgery to assess
disability. Their general practitioners (GPs) will be approached to determine
whether MACE and/or mortality have occurred during the 6 months follow up after
surgery.
Study burden and risks
In addition to routine care, patients will be asked to fill out the WHODAS 2.0
before surgery and additional blood will be drawn (7 cc in total) before
induction of anesthesia. Postoperatively, extra blood will be taken up to three
days after surgery (7 cc in total each time) during routine blood draws. At
postoperative day 1, an electrocardiogram (ECG) and if possible a transthoracic
echo (TTE) will be performed. Six months after surgery, patients will be asked
to fill out the WHODAS 2.0 for the second time and their GPs will be approached
to assess whether clinically relevant events have occurred. The study is
associated with a negligible risk as only noninvasive imaging procedures will
be performed and blood will be drawn. The treating physician will be notified
in case any unexpected findings from the ECG and TTE are observed meaning that
participation to this study could lead to early recognition of heart disease.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Patients are >= 60 years old;
- Patients undergo major non-cardiac surgery defined as all non-cardiac
surgical procedures requiring an expected hospital stay of at least 24 hours;
- Patients undergo elective surgery, defined as surgery that that has been
preceded by a preoperative consultation at the anesthesia preoperative
screening outpatient clinic.
Exclusion criteria
- 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03408522 |
| CCMO | NL62040.041.17 |