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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a type of exercise test, called Submaximal Cardiopulmonary Exercise Testing, to determine if it can better detect heart injuries after surgery compared to usual methods. It focuses on patients scheduled for moderate to high-risk, non-cardiac surgeries. The trial aims to identify which part of the exercise test most effectively spots these injuries. Individuals who can climb a flight of stairs and are set for surgery soon might be suitable for this study. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could improve surgical outcomes.

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 prior data suggests that submaximal cardiopulmonary exercise testing is safe for detecting myocardial injury after surgery?

Research has shown that submaximal cardiopulmonary exercise testing is generally safe for patients. Studies have found that this test effectively assesses heart function without causing harm. Most individuals, even those with heart conditions, tolerate it well.

Significant problems directly linked to submaximal exercise testing have not been reported, suggesting it is unlikely to cause major issues. This test is less intense than full exercise tests, reducing stress on the heart.

Although this trial does not focus on treatment safety, the exercise test itself has been safely used in various settings to better understand heart health. This background provides assurance about the test's safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about submaximal cardiopulmonary exercise testing because it offers a novel way to detect heart injury after surgery, which is crucial for timely intervention. Unlike standard methods that rely primarily on symptom evaluation and basic cardiac monitoring, this approach combines exercise testing with high-sensitivity troponin measurements to provide a more precise assessment of heart function and potential damage. This method could lead to earlier and more accurate detection of heart issues, allowing for better management and improved outcomes for patients post-surgery.

What evidence suggests that submaximal cardiopulmonary exercise testing is effective for detecting myocardial injury after surgery?

Studies have shown that submaximal cardiopulmonary exercise testing (CPET) can help predict post-surgery problems. Research indicates that CPET results effectively assess pre-surgery risk and forecast potential heart issues afterward. Early findings suggest CPET might identify early complications more effectively than traditional methods. This trial will involve participants receiving submaximal CPET alongside usual care to evaluate its effectiveness in detecting post-surgery heart problems. The test assesses heart and lung function during exercise, aiding in the identification of potential heart issues after surgery. With this information, doctors can better manage and reduce the risk of heart complications following surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Zyad J Carr, M.D.

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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

Provision of signed and dated informed consent form

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

Exclusion Criteria

I cannot climb a flight of stairs without stopping.

Pregnancy or lactation

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/phase-wounds-and-injuries-10-2024-6015b

Exercise Testing for Heart Injury Detection After Surgery What data supports the effectiveness of the treatment Submaximal Cardiopulmonary Exercise Testing for detecting heart injury after surgery? Cardiopulmonary ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40421445/

Preoperative submaximal cardiopulmonary exercise ... We aimed to determine whether submaximal CPET-derived measures outperform structured surveys in early postoperative complication detection.

3. atsjournals.org atsjournals.org/doi/10.1513/AnnalsATS.201610-780FR

Cardiopulmonary Exercise Testing and Surgery Cardiopulmonary exercise testing (CPET) is an effective preoperative risk stratification tool. CPET variables predict postoperative morbidity and mortality.

4. clinconnect.io clinconnect.io/trials/NCT06474754

Submaximal Cardiopulmonary Exercise Testing for This clinical trial is investigating whether a special exercise test can help doctors identify heart injury that may occur after non-heart surgeries. The main ...

5. periop.jmir.org periop.jmir.org/2025/1/e65805

Implementation of Brief Submaximal Cardiopulmonary Testing ... This study aims to determine if smCPET could be implemented in a high-volume presurgical evaluation clinic and, when compared to structured functional capacity ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10970724/

Cardiopulmonary Exercise Testing in Heart Failure - PMC In summary, CPET provides important information regarding outcomes in patients with heart failure in all three categories of ejection fractions, including ...

7. app.trialscreen.org app.trialscreen.org/trials/submaximal-cardiopulmonary-exercise-testing-detection-myocardial-injury-trial-nct06474754

Submaximal Exercise Testing for Myocardial Injury Detection This Interventional study is looking for people with Myocardial Injury After Non-cardiac Surgery, Submaximal Exercise Performance in New Haven United States ...

8. academic.oup.com academic.oup.com/ptj/article/80/8/782/2857751

Submaximal Exercise Testing: Clinical Application and ... This article contrasts maximal and submaximal exercise testing and describes the clinical application of submaximal testing.