CompletedNot Applicable

Myocardial Injury Following Non-cardiac Surgery

Sweden450 participantsStarted 2017-12-01

Plain-language 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.

Who can participate

Age range

45 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial looked at myocardial injury after non-cardiac surgery using cardiac MRI — if I've had or am planning a major surgery, should I be getting a cardiac MRI afterward to check for this kind of injury, and would my situation fit the pattern they were studying?
2Since the trial is now completed, has my doctor seen the results, and do those findings change how they would monitor my heart after a non-cardiac procedure?
3The trial focused on 'myocardial injury following non-cardiac surgery' — can my doctor explain what signs or symptoms this condition can look like, and whether there are any warning signs I should watch for after my own surgery?
4Cardiac MRI was the main tool used to detect this injury — is that level of imaging something that would realistically be available or recommended for me after surgery, or are there other monitoring approaches my care team would use instead?
5Since this was listed as 'Phase NA,' meaning it was more of an observational study than a treatment trial, does my doctor think the evidence it generated is strong enough to influence decisions about my post-surgical cardiac monitoring??

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Myocardial injury as seen by cMRI

Timeframe: < 3 days after rise in Troponin T

Trial details

NCT IDNCT03317561

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-03-31

View on ClinicalTrials.gov More Myocardial Injury trials