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

NCT05866874 | Recruiting

• 2 other identifiers: PMI VITAL2021-02274
• Study Type: observational
• Target: 875
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perioperative Myocardial Infarction; Perioperative Myocardial Injury

Keywords

Perioperative myocardial injury/infraction; Myocardial ischemia/diagnosis; Myocardial ischemia/epidemiology; Perioperative complications/diagnosis; PMI

Outcome Measures

Primary Outcomes (6)

• 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.

  3 days after surgery

• 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.

  1 year

• 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.

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

• 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).

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

• Comparison of the incidence and prognostic impact of PMI detected by using different troponin assays

  Comparison of the incidence and prognostic impact of PMI detected by using different high-sensitivity cardiac troponin I (hs-cTnI) assays in parallel to the clinical PMI-screening using high-sensitivity cardiac troponin T (hs-cTnT) assays.

  3 days after surgery

• Using biomarkers as tools for prediction of major cardiac complications in patients undergoing non-cardiac surgery

  Evaluation of the incremental value of additional cardiovascular biomarkers and continuous vital sign monitoring in the prediction of PMI and other cardiac complications, as well as the prediction of death, and the understanding of the pathophysiology of PMI.

  3 days after surgery

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

  3 days after surgery

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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
• Patients undergoing orthopaedic, traumatology, vascular, spinal, thoracic, neurosurgical, urological or visceral surgery
• Patient consent available

You may not qualify if:

• 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
• Moderate to severe dementia

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Myocardial Ischemia; Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Müller, MD, Prof

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Müller, MD, Prof

CONTACT

+41 61 328 6549; christian.mueller@usb.ch

Christian Puelacher, MD-PhD

CONTACT

+41 61 556 5830; christian.puelacher@usb.ch

Study Design

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

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 19, 2023
• Study Start: September 20, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)