Incidence and Outcome of Perioperative Myocardial Injury After Non-cardiac Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

This observational study includes patients undergoing major non-cardiac surgery, and screens them for the occurrence of perioperative myocardial injuries (PMI). Incidence, patient characteristics, pathophysiology, potential prevention and therapy strategies and 1-year outcomes of PMI will be described.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients received a perioperative hs-cTnT screening for PMI

Patient consent available

Disqualifiers

Patient's refusal

Trial population

Consecutive patients that underwent a systematic approach to PMI detection at the participating hospitals as clinical routine will be included. The screening consists of a pre-operative "baseline" measurement of hs-cTnT within 30 days prior to surgery, and two post-operative measurements taken on the first and second day after surgery. Screening is done in patients requiring hospitalization \>24 hours after surgery AND (aged ≥ 65 years OR history of coronary artery disease OR peripheral artery occlusive disease OR cerebrovascular disease). Patients are seen by a cardiologist in case of detection of a PMI.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Deaths in one year after non-cardiac surgery in patients with and without PMI

Time frame
1 year

Secondary outcomes

1

MACE in one year after non-cardiac surgery in patients with and without PMI

MACE is defined as a composite of death, acute myocardial infarction, life-threatening arrhythmia (cardiac arrest, sustained ventricular tachycardia, atrioventricular (AV) -block III), or acute heart failure (requiring admission to a hospital or intra-hospital transfer to the intensive care unit) within one year. Two independent cardiologists or anaesthesiologists will adjudicate all MACE.

Time frame
1 year
2

Incidence of PMI within a screening program in high-risk patients undergoing major non-cardiac surgery

PMI is defined as an absolute increase in h/s-cTn of the 99th percentile of healthy individuals for the respective assay above baseline cTn-value or between two postoperative values if the preoperative value was missing. PMI will be further classified as type I myocardial infarction, type II myocardial infarction, or myocardial injury due to non-cardiac causes.

Time frame
3 days after surgery
3

Number of patients with PMI with ischemic symptoms and signs detected in a screening program in high-risk patients undergoing major non-cardiac surgery

Patients with PMI are evaluated for: presence of chest pain, atypical symptoms, palpitations, dyspnea, edema, or nausea; ST-changes, Q-waves, T-wave abnormalities, new bundle branch block

Time frame
3 days after surgery
4

Number of patients with PMI with management changes after screening-induced consultation

Changes in management can be: changes in medication, intensification of surveillance, call for use of coronary angiography, myocardial stress testing, other, or none

Time frame
3 days after surgery, followed for 1 year

Other outcomes

1

Estimate potential effect of detection and management of PMI on major adverse cardiac events by a screening program implemented within clinical routine

Time frame
1 year
2

Compare cardiac troponin T and I in the detection of PMI

Time frame
3 days after surgery

Sponsors and contacts

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University Hospital, Basel, Switzerland

Lead sponsor

Cantonal Hospital of Aarau, Switzerland

Collaborator