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Perioperative Myocardial InjuryBASEL-PMINCT02573532

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

An observational study of Perioperative Myocardial Injury, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Perioperative Myocardial Injury
How many people
19,645 participants
Where
1 siteSwitzerland
Study dates
Oct 2015to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study 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.

Who may be able to join

  • Patients received a perioperative hs-cTnT screening for PMI
  • Patient consent available Exclusion criteria
  • Patient's refusal

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Switzerland1 site, 1 recruiting
  • University Hospital Basel

    Basel, Canton of Basel-City, 4031

    Christian Müller, MD, Prof, +41 61 328 6549, christian.mueller@usb.ch

    Christian Puelacher, MD-PhD

    Recruiting

Other trials in Switzerland

About this study

Official title: Basel Incidence, Patient Characteristics, Outcome and Possible Strategies to Improve Outcome of Perioperative Myocardial Injury After Non-cardiac Surgery: 1-Year Follow-up

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.

Read the detailed description

Background: Worldwide more than 230 million surgical operations are performed each year. Despite advances in all fields of medicine, there is still a significant risk of death related to major non-cardiac surgical procedures. The observed 30-day mortality depends on patient- as well as procedural factors and ranges between 1% and 10%. Cardiovascular complications, particularly perioperative myocardial injury/infarction (PMI) seem to be major contributors to about a third of all deaths. PMI may differ from spontaneous acute myocardial infarction (AMI). The vast majority of patients experiencing PMI do NOT have acute chest pain or other symptoms typical for AMI likely because they are narcotized or sedated and random ECGs are often not informative. Accordingly, most patients with PMI are currently not detected in routine clinical practice. Missed diagnosis is invariably associated with missed opportunity for the initiation of treatment. As most patients with PMI are missed in routine clinical care, the true incidence of and outcome after PMI are largely unknown. Prior studies have often not obtained a baseline sample and thus have suggested that all cTn elevations are likely due to AMI which may exaggerate the numbers. In addition, usually conventional less sensitive assays have been used. Further, the predominant pathophysiology of PMI is currently unknown. It has been suggested that type II MI characterized by coronary perfusion pressure mismatch and not type I MI characterized by acute thrombotic coronary occlusion is the predominate mechanism. However, autopsy data suggest that plaque rupture is more common. Thus, it may be that type 2 AMI is more common but that the modest incidence of type 1 AMI is not dangerous prognostically.

Aim: To explore the incidence, patient characteristics, pathophysiology, potential prevention and therapy strategies and long-term outcome of PMI after major non-cardiac surgery

Methodology: Consecutive high-risk patients undergoing major non-cardiac surgery will be included and followed for one year for the occurrence of all-cause death and other major adverse cardiac events. Patients receive a standardized assessment of cardiovascular status and systematic perioperative screening for PMI using high sensitivity cardiac troponin T (hs-cTnT) at baseline prior to surgery, as well as on day 1 and day 2 after surgery. Acute cardiac injury will be 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 is missing. A search for possible alternative causes for hs-cTnT elevations will be aggressively sought if a rising pattern of values is detected. Two independent experts will adjudicate the most likely cause of PMI using all clinical information pertaining to the individual patient including the 12-lead ECG, peak hs-cTnT blood concentrations, coronary angiography and myocardial perfusion scanning. Influence of PMI on occurrence of all-cause death will be assessed using multivariate Cox-proportional hazards analysis. Further, pre-operative and post-operative prediction models for death, major adverse cardiac events, and PMI shall be derived using a derivation-validation design.

Potential Significance: This study will generate scientific data that have major scientific implications by contributing to closing current knowledge gaps concerning the influence of PMI on long-term mortality as well as the incidence, patient characteristics, and pathophysiology of PMI after non-cardiac surgery. This knowledge will have immediate clinical implications as it could e.g. lead to major changes in perioperative management with reconsiderations of the necessary target blood pressure to avoid coronary perfusion mismatch and consecutive cardiac injury.

Keywords
myocardial ischemia/diagnosis, myocardial ischemia/epidemiology, perioperative, perioperative complications/diagnosis, prognosis
Medical subject headings
Myocardial Ischemia, Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 year

Secondary outcomes (12)
  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.

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 3 days after surgery, followed for 1 year

  5. Generate a pre- and an immediate postoperative prediction score for occurrence of major adverse cardiac events including PMI

    Measured: 1 year

  6. Costs related to the introduction of perioperative hs-cTnT screening.

    Health system costs of implementation of screening is calculated as number of interventions initiated additionally to routine care after screening

    Measured: 1 year

  7. Derive and validate a risk score in patients with different subtypes of PMI for the occurrence of major cardiac adverse events to inform treatment decisions.

    Endpoint: percentage of correctly classified patients in validation cohort.

    Measured: 1 year

  8. Derive and validate an improved diagnostic screening approach for detection of PMI.

    Endpoint: sensitivity and specificity for PMI.

    Measured: 3 days after surgery

  9. Evaluate the effect of pre-operative medication use.

    Endpoint: number of patients undergoing elective non-cardiac surgery suffering PMI (cardiac origin) after non-cardiac surgery with vs without pre-operative statin/RAAS blocker/β-blocker therapy.

    Measured: 3 days after surgery

  10. Evaluate the effect of post-PMI medication on outcome of PMI.

    Endpoint: death and MACE in patients suffering PMI (cardiac origin) with vs without statin/RAAS blocker/β-blocker therapy.

    Measured: 1 year

  11. Description of PMI subtypes and potential diagnostic criteria available at time of PMI detection.

    Measured: 3 days after surgery

  12. Validate the diagnosis of PMI within a screening program in high-risk patients undergoing major non-cardiac sur-gery with other troponin assays.

    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.

    Measured: 3 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
19,645 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02573532
Sponsor's protocol ID
BASEL-PMI
Acronym
BASEL-PMI
Status last verified
Sep 2026
First submitted
1 Oct 2015
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Haziri F, Durak K, Glarner N, Ergin E, Burri-Winkler K, Kaplan E, Thommen V, Pargger M, Hure G, Giger RV, Bolliger D, Steiner LA, Mujagic E, Lardinois D, Scharen S, Mueller A, Kunz M, Stolte T, Mahfoud F, Strebel I, Puelacher C, Gualandro DM, Mueller C. Perioperative discontinuation of SGLT2-inhibitors and cardiac complications after noncardiac surgery: secondary analysis of two prospective observational cohort studies. Br J Anaesth. 2026 Aug;137(2):440-449. doi: 10.1016/j.bja.2026.05.004. Epub 2026 Jun 11.

    PubMed 42270529
  • Champetier A, Lopez-Ayala P, Puelacher C, Durak K, Kaplan E, Gualandro D, Glarner N, Pargger M, Hure G, Burri-Winkler K, Bolliger D, Steiner LA, Scharen S, Mujagic E, Clauss M, Mueller AM, Lardinois D, Boeddinghaus J, Mahfoud F, Strebel I, Mueller C. External validation of PreOpNet to predict 30-day mortality after major non-cardiac surgery using digital electrocardiogram. NPJ Digit Med. 2025 Oct 16;8(1):613. doi: 10.1038/s41746-025-01983-7.

    PubMed 41102258
  • Thommen V, Gualandro DM, Puelacher C, Durak K, Glarner N, Cardozo FAM, Bolliger D, Caramelli B, Mujagic E, Mueller C; BASEL-PMI Investigators. Prevalence, phenotypes, and long-term outcomes of cardiac complications after arterial vascular surgery. J Vasc Surg. 2025 Dec;82(6):2151-2160.e5. doi: 10.1016/j.jvs.2025.07.057. Epub 2025 Aug 13.

    PubMed 40816634
  • Durak K, Burri-Winkler K, Hure G, Strebel I, Reinhardt J, Thommen V, Pargger M, Glarner N, Haziri F, Seeberger E, Doyle N, Bolliger D, Steiner LA, Mujagic E, Lardinois D, Scharen S, Mueller A, Mahfoud F, Gualandro DM, Puelacher C, Mueller C. Robotic process automation to identify patients at high risk for perioperative myocardial infarction or injury: a prospective, blinded, paired reader-controlled single-centre study. Br J Anaesth. 2025 Nov;135(5):1153-1160. doi: 10.1016/j.bja.2025.07.035. Epub 2025 Jul 31.

    PubMed 40750466
  • Glarner N, Puelacher C, Gualandro DM, Pargger M, Hure G, Maiorano S, Strebel I, Fried S, Bolliger D, Steiner LA, Lampart A, Lurati Buse G, Mujagic E, Lardinois D, Kindler C, Guerke L, Schaeren S, Mueller A, Clauss M, Buser A, Hammerer-Lercher A, Mueller C; Basel-PMI Investigators. Association of preoperative beta-blocker use and cardiac complications after major noncardiac surgery: a prospective cohort study. Br J Anaesth. 2024 Jun;132(6):1194-1203. doi: 10.1016/j.bja.2024.02.023. Epub 2024 Apr 15.

    PubMed 38627137
  • Glarner N, Puelacher C, Gualandro DM, Lurati Buse G, Hidvegi R, Bolliger D, Lampart A, Burri K, Pargger M, Gerhard H, Weder S, Maiorano S, Meister R, Tschan C, Osswald S, Steiner LA, Guerke L, Kappos EA, Clauss M, Filipovic M, Arenja N, Mueller C; for the BASEL-PMI Investigators. Guideline adherence to statin therapy and association with short-term and long-term cardiac complications following noncardiac surgery: A cohort study. Eur J Anaesthesiol. 2023 Nov 1;40(11):854-864. doi: 10.1097/EJA.0000000000001903. Epub 2023 Sep 25.

    PubMed 37747427
  • Puelacher C, Gualandro DM, Glarner N, Lurati Buse G, Lampart A, Bolliger D, Steiner LA, Grossenbacher M, Burri-Winkler K, Gerhard H, Kappos EA, Clerc O, Biner L, Zivzivadze Z, Kindler C, Hammerer-Lercher A, Filipovic M, Clauss M, Gurke L, Wolff T, Mujagic E, Bilici M, Cardozo FA, Osswald S, Caramelli B, Mueller C; BASEL-PMI Investigators. Long-term outcomes of perioperative myocardial infarction/injury after non-cardiac surgery. Eur Heart J. 2023 May 14;44(19):1690-1701. doi: 10.1093/eurheartj/ehac798.

    PubMed 36705050
  • Arslani K, Gualandro DM, Puelacher C, Lurati Buse G, Lampart A, Bolliger D, Schulthess D, Glarner N, Hidvegi R, Kindler C, Blum S, Cardozo FAM, Caramelli B, Gurke L, Wolff T, Mujagic E, Schaeren S, Rikli D, Campos CA, Fahrni G, Kaufmann BA, Haaf P, Zellweger MJ, Kaiser C, Osswald S, Steiner LA, Mueller C; BASEL-PMI Investigators. Cardiovascular imaging following perioperative myocardial infarction/injury. Sci Rep. 2022 Mar 15;12(1):4447. doi: 10.1038/s41598-022-08261-6.

    PubMed 35292719
  • Lurati Buse GAL, Puelacher C, Gualandro DM, Kilinc D, Glarner N, Hidvegi R, Bolliger D, Arslani K, Lampart A, Steiner LA, Kindler C, Wolff T, Mujagic E, Guerke L, Mueller C; Incidence and Outcome of Perioperative Myocardial Injury After Non-cardiac Surgery (BASEL-PMI) Investigators. Adherence to the European Society of Cardiology/European Society of Anaesthesiology recommendations on preoperative cardiac testing and association with positive results and cardiac events: a cohort study. Br J Anaesth. 2021 Sep;127(3):376-385. doi: 10.1016/j.bja.2021.06.027. Epub 2021 Jul 28.

    PubMed 34330416
  • Sazgary L, Puelacher C, Lurati Buse G, Glarner N, Lampart A, Bolliger D, Steiner L, Gurke L, Wolff T, Mujagic E, Schaeren S, Lardinois D, Espinola J, Kindler C, Hammerer-Lercher A, Strebel I, Wildi K, Hidvegi R, Gueckel J, Hollenstein C, Breidthardt T, Rentsch K, Buser A, Gualandro DM, Mueller C; BASEL-PMI Investigators. Incidence of major adverse cardiac events following non-cardiac surgery. Eur Heart J Acute Cardiovasc Care. 2021 Jun 30;10(5):550-558. doi: 10.1093/ehjacc/zuaa008. Epub 2020 Oct 14.

    PubMed 33620378
  • Lurati Buse GAL, Puelacher C, Gualandro DM, Genini AS, Hidvegi R, Bolliger D, Arslani K, Steiner LA, Kindler C, Mueller C; BASEL-PMI Investigators. Association between self-reported functional capacity and major adverse cardiac events in patients at elevated risk undergoing noncardiac surgery: a prospective diagnostic cohort study. Br J Anaesth. 2021 Jan;126(1):102-110. doi: 10.1016/j.bja.2020.08.041. Epub 2020 Oct 17.

    PubMed 33081973
  • Puelacher C, Gualandro DM, Lurati Buse G, Bolliger D, Marbot S, Kindler C, Hammerer-Lercher A, Gurke L, Steiner L, Mueller C. Etiology of Peri-Operative Myocardial Infarction/Injury After Noncardiac Surgery and Associated Outcome. J Am Coll Cardiol. 2020 Oct 20;76(16):1910-1912. doi: 10.1016/j.jacc.2020.08.043. No abstract available.

    PubMed 33059838
  • du Fay de Lavallaz J, Puelacher C, Lurati Buse G, Bolliger D, Germanier D, Hidvegi R, Walter JE, Twerenbold R, Strebel I, Badertscher P, Sazgary L, Lampart A, Espinola J, Kindler C, Hammerer-Lercher A, Thambipillai S, Guerke L, Rentsch K, Buser A, Gualandro D, Jakob M, Mueller C; BASEL-PMI Investigators. Daytime variation of perioperative myocardial injury in non-cardiac surgery and effect on outcome. Heart. 2019 Jun;105(11):826-833. doi: 10.1136/heartjnl-2018-313876. Epub 2018 Dec 12.

    PubMed 30541757
  • Puelacher C, Lurati Buse G, Seeberger D, Sazgary L, Marbot S, Lampart A, Espinola J, Kindler C, Hammerer A, Seeberger E, Strebel I, Wildi K, Twerenbold R, du Fay de Lavallaz J, Steiner L, Gurke L, Breidthardt T, Rentsch K, Buser A, Gualandro DM, Osswald S, Mueller C; BASEL-PMI Investigators. Perioperative Myocardial Injury After Noncardiac Surgery: Incidence, Mortality, and Characterization. Circulation. 2018 Mar 20;137(12):1221-1232. doi: 10.1161/CIRCULATIONAHA.117.030114. Epub 2017 Dec 4.

    PubMed 29203498

Questions about this trial

What is this clinical trial studying?

An observational study of Perioperative Myocardial Injury, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christian Müller, MD, Prof (+41 61 328 6549, christian.mueller@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Deaths in one year after non-cardiac surgery in patients with and without PMI (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02573532, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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