Monitoring of Vital Signs for Phenotyping of Perioperative Myocardial Infarction/Injury After Noncardiac Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-85
SponsorUniversity Hospital, Basel, Switzerland

About this trial

The goal of this observational prospective cohort study is to learn about the pathophysiology of perioperative myocardial infarction/injury in high-risk patients undergoing major non-cardiac surgery.

Participants will:

* Wear wearable device (Basler Band) for up to seven days after the operation or until hospital discharge * Provide three blood samples. A venous specimen of blood (25 mL) will be collected preoperatively and on postoperative days 1 and 2. * Be contacted to answer a questionnaire one year after the surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient eligible for routine PMI-screening

Patient requiring hospitalisation with ≥ 2 overnight stays after surgery

Age ≥ 40 years to ≤ 85 AND history of coronary artery disease (CAD), peripheral artery disease (PAD), cerebrovascular disease/stroke, insulin-dependent diabetes mellitus (IDDM), or chronic heart failure (CHF)

Elective surgery

Disqualifiers

Patient's refusal

Heart surgery, cardiac arrest, acute mycardial infarction (AMI), cardiac valve intervention, or cardiac catheter ablation within 14 days prior to surgery OR involvement of heart surgery at index surgery OR surgery planned on cardiopulmonary bypass

Patients undergoing plastic/reconstructive, ophthalmologic, dental, hand surgery, or ear-nose-and-throat surgery

Chronic renal failure on dialysis, unless undergoing renal transplant surgery

Trial population

Consecutive patients that underwent a systematic approach to PMI detection at the hospital as clinical routine will be included.

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

Perioperative myocardial infarction/injury (PMI)

PMI is defined as an absolute increase in high-sensitivity cardiac troponin (hs-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. Two independent cardiologists or anaesthesiologists will adjudicate all PMI cases.

Time frame
3 days after surgery
2

Major adverse cardiac and cerebral events (MACCE)

MACCE is defined as a composite of all-cause death, acute myocardial infarction, acute heart failure (requiring admission to a hospital or intra-hospital transfer to the internal medicine or intensive care unit), clinically relevant arrhythmias (cardiac arrest, sustained ventricular tachycardia, atrioventricular (AV)-block III, high rate atrial fibrillation/flutter requiring treatment, bradycardia requiring pacemaker, or rhythmogenic syncope) and stroke/transient ischaemic attack within one year.

Time frame
1 year
3

Postoperative atrial fibrillation (POAF)

POAF is defined as new-onset atrial fibrillation (AF) in the immediate postoperative period of duration/burden at least 30 minutes detected using continuous monitoring of vital signs using the wearable device (Basler Band), but not recorded and documented using the current clinical monitoring standards.

Time frame
During surgery and up to 7 days after surgery or until hospital discharge.
4

Documentation and quantification of the frequency and duration of tachyarrhythmia, bradycardia, hypotension, hypertension, and/or hypoxaemia.

Frequency and duration of tachyarrhythmia, bradycardia, hypotension, hypertension, and/or hypoxaemia detected using continuous monitoring of vital signs using the "Basler Band" throughout the whole perioperative period, and use this information to characterise PMI. Major abnormalities will be defined as: hypotension (systolic blood pressure \<85 mmHg or more than 40 mmHg lower than at the initiation of analgosedation for \>10 minutes), hypertension (systolic blood pressure \>190 mmHg \>20 minutes), tachyarrhythmia (ventricular rate \>120 for \>20 minutes), bradycardia (asystole \>10 s or heart rate \<40/min for \>30 minutes), and/or hypoxaemia (pulse oximetry \<85% for \>20 minutes).

Time frame
During surgery and up to 7 days after surgery or until discharge.

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

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