Exercise Testing for Heart Injury Detection After Surgery

(EnhanceMINS Trial)

Overseen By Zyad J Carr, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Recent myocardial infarction, Anginal symptoms, Congestive heart failure, Syncope, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

61 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Submaximal Cardiopulmonary Exercise Testing for detecting heart injury after surgery?

Cardiopulmonary exercise testing is shown to be effective in assessing heart function and predicting outcomes in surgical patients by measuring how well the heart and lungs work together during exercise. It helps identify patients at higher risk of complications after surgery, which can guide better care and improve recovery. ^{1 2 3 4 5}

Is cardiopulmonary exercise testing safe for humans?

Cardiopulmonary exercise testing (CPET) is generally considered safe when proper precautions and safety standards are followed, as it is a noninvasive tool used to assess heart and lung function before surgery. It is used to predict risks and outcomes in various surgeries, and while it helps in identifying potential complications, the testing itself is not associated with significant safety concerns. ^{6 7 8 9 10}

How does the treatment Submaximal Cardiopulmonary Exercise Testing differ from other treatments for detecting heart injury after surgery?

Submaximal Cardiopulmonary Exercise Testing is unique because it uses exercise to assess heart and lung function, specifically measuring the anaerobic threshold (the point at which the body starts to use more energy from anaerobic sources). This approach helps detect heart issues that might not be visible through other tests, making it a valuable tool for identifying cardiac risk in patients who have undergone surgery. ^{1 11 12 13 14}

Research Team

Zyad J Carr, M.D.

Principal Investigator

Yale University

Eligibility Criteria

This trial is for individuals undergoing non-cardiac surgery who will be assessed for myocardial injury, which is heart damage that can occur after surgery. Participants must be able to perform a submaximal cardiopulmonary exercise test before their operation.

Inclusion Criteria

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

Provision of signed and dated informed consent form

Exclusion Criteria

I cannot climb a flight of stairs without stopping.

I have been admitted or referred for fainting in the last 6 months.

Pregnancy or lactation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Evaluation

Participants undergo submaximal cardiopulmonary exercise testing to assess preoperative risk

1 day

1 visit (in-person)

Surgery and Immediate Postoperative Monitoring

Participants undergo surgery and are monitored for myocardial injury using high-sensitivity troponin measurements on operative day 0 and postoperative days 1, 2, and 3

4 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for major adverse cardiovascular events and other outcomes up to 30 days post-surgery

30 days

Extended Follow-up

Participants are monitored for readmission and length of stay up to 60 days post-surgery

60 days

Treatment Details

Interventions

• Submaximal Cardiopulmonary Exercise Testing

Trial Overview The study tests if a short submaximal cardiopulmonary exercise test can predict heart damage after non-cardiac surgery better than usual care. It involves pre-surgery testing and monitoring high-sensitivity troponin levels post-surgery for three days.

Participant Groups

Group I: Submaximal cardiopulmonary exercise testing Experimental Treatment 3 Interventions

Single arm design; selected participants will receive both usual care (Duke Activity Status Index) and submaximal cardiopulmonary exercise testing. All participants will receive high-sensitivity troponin measurements on operative day 1 and postoperative day 1,2,3

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical review: how to identify high-risk surgical patients. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Use of the pre-operative shuttle walk test to predict morbidity and mortality after elective major colorectal surgery. [2014]

3. England pubmed.ncbi.nlm.nih.gov

Patients' inability to perform a preoperative cardiopulmonary exercise test or demonstrate an anaerobic threshold is associated with inferior outcomes after major colorectal surgery. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Cardiopulmonary Exercise Testing and Surgery. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Cardiopulmonary exercise testing: a review of methods and applications in surgical patients. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Performance of cardiopulmonary exercise testing for the prediction of post-operative complications in non cardiopulmonary surgery: A systematic review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Cardiopulmonary exercise testing for predicting postoperative morbidity in patients undergoing hepatic resection surgery. [2018]

8. Scotland pubmed.ncbi.nlm.nih.gov

Cardiopulmonary exercise testing and cardiopulmonary morbidity in patients undergoing major head and neck surgery. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Submaximal treadmill exercise testing of patients with coronary artery disease. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Cardiopulmonary exercise testing predicts 5 yr survival after major surgery. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of the effects of exercise training after coronary artery bypass surgery. [2016]

12. England pubmed.ncbi.nlm.nih.gov

Physical training after heart valve replacement. [2020]

13. Germany pubmed.ncbi.nlm.nih.gov

[Cardiopulmonary capacity in patients before and after prosthetic valve replacement]. [2007]

14. Japan pubmed.ncbi.nlm.nih.gov

Maximal cardiac output in angina patients before abd after coronary artery surgery. [2019]