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

NCT02573532 | Recruiting

• 1 other identifier: BASEL-PMI
• Study Type: observational
• Target: 19,645
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Perioperative Myocardial Injury

Keywords

myocardial ischemia/diagnosis; myocardial ischemia/epidemiology; perioperative; perioperative complications/diagnosis; prognosis

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (12)

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

  1 year

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

  3 days after surgery

• 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

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

  3 days after surgery, followed for 1 year

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

  1 year

Other Outcomes (2)

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

  1 year

• Compare cardiac troponin T and I in the detection of PMI

  3 days after surgery

Eligibility Criteria

• Age: 45 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 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.

You may qualify if:

• Patients received a perioperative hs-cTnT screening for PMI

You may not qualify if:

• Patient's refusal

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Cantonal Hospital of Aarau, Switzerland: collaborator

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

Related Publications (12)

• 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.

  PMID: 41102258 DERIVED

• 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.

  PMID: 40750466 DERIVED

• 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.

  PMID: 38627137 DERIVED

• 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.

  PMID: 37747427 DERIVED

• 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.

  PMID: 36705050 DERIVED

• 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.

  PMID: 35292719 DERIVED

• 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.

  PMID: 34330416 DERIVED

• 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.

  PMID: 33620378 DERIVED

• 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.

  PMID: 33081973 DERIVED

• 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.

  PMID: 33059838 DERIVED

• 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.

  PMID: 30541757 DERIVED

• 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.

  PMID: 29203498 DERIVED

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: October 1, 2015
• First Posted: October 9, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

CH (1)