Myocardial Injury in Noncardiac Surgery in Sweden (NCT03436238) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Myocardial Injury in Noncardiac Surgery in Sweden
Sweden1,269 participantsStarted 2017-05-15
Plain-language 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.
Who can participate
Age range
50 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:
* 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).)
Exclusion Criteria:
* Patient not fulfilling inclusion study criteria above and/or clinician refusal and/or non-eligible as defined below.
Patients undergoing the following surgical procedures will NOT be eligible:
* transplantation
* trauma
* endocrine
* vascular
* endovascular
The presence of any one of the following will also lead to exclusion of the patient:
* 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 \< 1…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.