Submaximal Cardiopulmonary Exercise Testing for Detection of Myocardial Injury After Noncardiac S… (NCT06474754) | Clinical Trial Compass
TerminatedNot Applicable
Submaximal Cardiopulmonary Exercise Testing for Detection of Myocardial Injury After Noncardiac Surgery
Stopped: Funding limitations.
United States10 participantsStarted 2025-03-30
Plain-language summary
The goal of this clinical trial is to learn whether physicians can associate evidence of myocardial injury after surgery with findings obtained from submaximal cardiopulmonary exercise testing. The main questions are:
Is detection of postoperative myocardial injury with submaximal cardiopulmonary exercise testing superior to using usual care?
And which submaximal cardiopulmonary exercise testing measure is better?
Participants will undergo evaluation with a short submaximal cardiopulmonary exercise test, then undergo surgery. Myocardial injury will be measured on postoperative days 0, 1, 2, and 3 (during and up to 3 days after surgery). These results will analyzed by comparing it to findings from the submaximal cardiopulmonary exercise test.
If there is a relationship, this will help anesthesiologists and surgeons assign certain treatments that may reduce the risk of developing myocardial injury after surgery.
Who can participate
Age range
45 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
. Provision of signed and dated informed consent form.
. Stated willingness to comply with all study procedures and availability for the duration of the study.
. Biological male or female, aged 45 years or older.
. In good general health as evidenced by medical history or diagnosed with metabolic equivalents (self-reported ability to climb 1 flight of stairs).
. Revised Cardiac Risk Index less than or equal to three.
. Willing to accept phlebotomy on operative day 0, 1, 2, and 3, as part of usual care.
. Scheduled for moderate to high-risk elective non-cardiac surgery with an expected 24-72 hour stay within 60 days of enrollment in the study.
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 was terminated before completing — do you know why it was stopped, and does that affect whether its findings about using exercise testing to detect myocardial injury after surgery are still useful for my situation?
2Since this study was looking at submaximal cardiopulmonary exercise testing before noncardiac surgery, is that kind of preoperative fitness test something you'd still consider for me to help assess my heart risk going into surgery?
3The trial was focused on detecting MINS — myocardial injury after noncardiac surgery — which I understand can happen without obvious symptoms; how would you currently monitor me for that risk if I'm having a noncardiac procedure?
4Because this trial was terminated and never reached a clear phase of proven benefit, are there other completed studies or standard clinical tools you'd use instead to evaluate my heart health before surgery?
5Given that this study was in a preoperative setting, how does my current heart health factor into the timing or type of noncardiac surgery I might need, and should I see a cardiologist before we proceed?
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
1
MINS
Timeframe: Operative Day 0, Postoperative Day 1, 2 or 3
. Inability to perform study procedures as defined by inability to achieve greater than 4 metabolic equivalents (cannot climb 1 flight of stairs reliably).
. Pregnancy or lactation.
. Inability to give independent informed consent.
. Revised cardiac risk index greater than 3.
. Recent myocardial infarction (less than 6 weeks).
. Recent anginal symptoms (stable or unstable) within past 6 months.
. Recent admission or endorsement for congestive heart failure within 6 months
. Recent admission or endorsement for syncope within 6 months.