Myocardial Injury Following Non-cardiac Surgery

NCT03317561 | Completed

• 1 other identifier: 2017-11-01
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

It is estimated that \> 200 million patients in the world undergo surgery each year of which approximately 10 million will suffer from a myocardial injury in the perioperative period. Mortality is high in patients with myocardial injury since it often goes undiagnosed and management is unclear. In contrast to myocardial infarction diagnosed in the emergency room (non-surgical patient) where treatment is well established today, patients suffering from a perioperative myocardial injury have a poorer outcome. Additionally, the patho-physiology of myocardial injury is unknown in the individual patient, non-invasive diagnostic tools are not widely available and treatment remains unknown. Most cases of myocardial injury in Non-cardiac surgery (MINS) are seen within the first 48-72 h after surgery and a majority have no symptoms. Many patients developing MINS are \< 65 years old and non-diabetics, an age group that usually does not have coronary artery disease. A elevated Troponin T (TnT) without symptoms or ECG changes, typically occurring in the perioperative period, is an independent predictor of 30-day mortality. Surgical trauma also causes an increase in several pro-inflammatory cytokines, which together with sympathetic over-activity and platelet activation, leads to a hyper-coagulant state, and in turn may cause coronary thrombosis. It is possible that some cases of MINS also result from oxygen supply-delivery mismatch. To our knowledge, no study has investigated the cause of MINS in patients presenting with increased TnT in the perioperative period. Our aim is therefore to investigate patients having MINS in order to better understand its aetiology and subsequently develop focused strategies to reduce risks.

Conditions

Myocardial Injury; Surgery--Complications

Keywords

troponin; major surgery

Outcome Measures

Primary Outcomes (1)

• Myocardial injury as seen by cMRI

  Number of patients with a significant myocardial detected by cMRI in relation to the number that had an increase in TnT postoperatively

  < 3 days after rise in Troponin T

Secondary Outcomes (5)

• Protocolized echocardiography

  < 48 hours after rise in Troponin T

• Kidney injury

  < 3 days after induction of anesthesia

• Mortality

  Within 365 days

• Number of patients with significant Hypotension (perioperative)

  24 hours after induction of anesthesia

• Number of patients with significant ST-T segment changes (perioperative)

  0 - 24 hours anesthesia induction

Study Arms (2)

Myocardial injury

Subjects who have had an increase in troponin T level (\> 99 percentile) in the perioperative period shall form the cases.

Control

Subjects who do not have an increase in troponin T level (\< 99 percentile) in the perioperative period shall form the controls.

Eligibility Criteria

• Age: 45 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an increase in Troponin T (\> 20 ng/L) or a \> 50% rise from preoperative values after induction of anesthesia will form the Myocardial injury Group while those without an increase in Troponin T (\< 14 ng/L) will form the Control group

You may qualify if:

• Patients in the age group \> 45 years
• Non-cardiac, vascular surgery

You may not qualify if:

• Patients with atrial fibrillation
• Moderate-severe renal insufficiency (GFR \< 50)
• Allergy to iv contrast or drugs used for diagnostics will be excluded
• Known lung embolism
• Inability to comprehend the study or language barriers

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska Hospital, Solna

Stockholm, 17176, Sweden

Location

Related Publications (1)

• Valadkhani A, Gupta A, Cauli G, Nordstrom JL, Rohi A, Tufexis P, Hallsjo Sander C, Jacobsson M, Bell M. Diastolic Versus Systolic or Mean Intraoperative Hypotension as Predictive of Perioperative Myocardial Injury in a White-Box Machine-Learning Model. Anesth Analg. 2025 Jul 1;141(1):5-15. doi: 10.1213/ANE.0000000000007379. Epub 2025 Feb 20.

  PMID: 39977341 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

Study Officials

• Anil Gupta, MD, PhD

  Department of Clinical Research, and PMI, Karolinska Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 23, 2017
• Study Start: December 1, 2017
• Primary Completion: March 31, 2023
• Study Completion: June 30, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)