Myocardial Injury in Noncardiac Surgery in Sweden

NCT03436238 | Active Not Recruiting

• 1 other identifier: MINSS
• Study Type: observational
• Target: 1,269
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this multicentre, prospective, observational study is to identify robust biochemical markers that predict adverse cardiovascular outcomes and mortality in patients undergoing major abdominal surgery.

Conditions

Perioperative/Postoperative Complications; Risk Factor, Cardiovascular

Keywords

Perioperative; Biomarkers; Troponin; Prodrenomedullin; Endothelin; Perioperative Complications; Myocardial injury; Major adverse cardiovascular events

Outcome Measures

Primary Outcomes (2)

• 30-day mortality

  All-cause mortality at 30 days post-surgery.

  30 days post surgery

• 30-day MACCE

  Major adverse cardio- cerebrovascular events (MACCE) at 30 days post-surgery.

  30 days post surgery

Secondary Outcomes (2)

• 12-month mortality

  12 months post surgery

• 12-month MACCE

  12 months post surgery

Other Outcomes (2)

• Net reclassification index (NRI)

  30 days post surgery

• Long term mortality

  3 years and 5 years

Study Arms (1)

MINSS cohort

Adult patients \>= 50 years old undergoing elective, major, abdominal surgery requiring at least one overnight stay in hospital. Major abdominal surgery is defined as those classified as major OR major/complex by the Surgical Outcome Risk Tool (SORT) (www.sortsurgery.com).

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective, major abdominal surgery at participating centres, requiring general anaesthesia, and requiring at least one overnight stay.

You may qualify if:

• Adult patients undergoing elective, major abdominal surgery\*.
• (\*Major abdominal surgery requiring general anaesthesia, and requiring at least one overnight stay. Major abdominal surgery is defined as those classified as major OR major/complex by the Surgical Outcome Risk Tool (SORT) (www.sortsurgery.com).
• In essence major surgery is one that penetrates and exposes a body cavity or produces a substantial impairment of physical or physiologic function or involves extensive dissection or transection. Examples of a major abdominal surgery include, but are not limited to, any procedure involving a laparotomy or laparoscopic procedures of the stomach, duodenum, small and large intestine and rectum. It also includes but is not limited to procedures on the reproductive system (total abdominal hysterectomy, salpingo-oophorectomy) and genitourinary system (nephrectomy, cystectomy).)

You may not qualify if:

• Patients undergoing the following surgical procedures will NOT be eligible:
• transplantation
• trauma
• endocrine
• vascular
• endovascular
• ACS at presentation (clinical assessment or documentation)
• New or decompensated congestive heart failure at presentation (clinical assessment or documentation)
• Documented severe aortic stenosis (valve area \< 1cm2)
• Reduced LVEF (\<40%); if no LVEF is available, it will be assumed to be \>40%
• Inability to follow the procedures of the study, e.g. due to language problems, dementia, etc. of the participant

Sponsors & Collaborators

• Linkoeping University: lead
• Region Östergötland: collaborator
• Medical Research Council of Southeast Sweden: collaborator

Study Sites (7)

Kristianstad KRYH Hospital

Kristianstad, Skåne County, Sweden

Location

Eskilstuna Hospital

Eskilstuna, Sweden

Location

Ryhov County Hospital

Jönköping, Sweden

Location

Skane University Hospital Lund

Lund, Sweden

Location

Skane University Hospital Malmö

Malmo, Sweden

Location

Vrinnevi Hospital

Norrköping, Sweden

Location

Department of Anaesthesia and Intensive Care, Linkoeping University Hospital, Region Östergötland

Linköping, Östergötland County, 50185, Sweden

Location

Related Publications (2)

• Falt M, Ahman R, Hammarskjold F, Lyckner S, Jawad M, Andersson U, Fredrikson M, Sperber J, Elander L, De Geer L, Didriksson H, Jonsson C, Andersson H, Chew MS. Long-term outcomes of time-dependent phenotypes of perioperative myocardial injury☆. BJA Open. 2025 Jun 4;14:100422. doi: 10.1016/j.bjao.2025.100422. eCollection 2025 Jun.

  PMID: 40529719 DERIVED

• Chew MS, Puelacher C, Patel A, Hammarskjold F, Lyckner S, Kollind M, Jawad M, Andersson U, Fredrikson M, Sperber J, Johnsson P, Elander L, Zeuchner J, Linhardt M, De Geer L, Rolander WG, Gagno G, Didriksson H, Pearse R, Mueller C, Andersson H. Identification of myocardial injury using perioperative troponin surveillance in major noncardiac surgery and net benefit over the Revised Cardiac Risk Index. Br J Anaesth. 2022 Jan;128(1):26-36. doi: 10.1016/j.bja.2021.10.006. Epub 2021 Nov 29.

  PMID: 34857357 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle S Chew, MBBS, PhD

  Linkoeping University and Region Östergötland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Senior Consultant

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: February 19, 2018
• Study Start: May 15, 2017
• Primary Completion: March 31, 2020
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

SE (7)