Using exercise tests to detect heart injury after non-cardiac surgery

Enhancing Precise Perioperative Risk Surveillance: Validation of Submaximal Cardiopulmonary Exercise Testing to Usual Care for Detection of Myocardial Injury After Noncardiac Surgery

This study tests if a simple exercise test can help find heart injuries in people after they have non-heart surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 61 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT06474754 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine if submaximal cardiopulmonary exercise testing can effectively identify myocardial injury following non-cardiac surgery. Participants will undergo a brief exercise test before their surgery, and their heart health will be monitored for three days post-surgery. The study will compare the effectiveness of this exercise testing method against standard care in detecting heart injuries. If successful, the findings could lead to improved treatment strategies for patients at risk of myocardial injury after surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 45 and older scheduled for moderate to high-risk elective non-cardiac surgery.

Not a fit: Patients who are unable to perform the required exercise test or have a high revised cardiac risk index may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the ability to predict and prevent heart injuries in patients undergoing non-cardiac surgery.

How similar studies have performed: Previous studies have shown promise in using cardiopulmonary exercise testing for risk assessment, but this specific approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Biological male or female, aged 45 years or older.
4. In good general health as evidenced by medical history or diagnosed with metabolic equivalents (self-reported ability to climb 1 flight of stairs).
5. Revised Cardiac Risk Index less than or equal to three.
6. Willing to accept phlebotomy on operative day 0, 1, 2, and 3, as part of usual care.
7. 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.

Exclusion Criteria:

1. Inability to perform study procedures as defined by inability to achieve greater than 4 metabolic equivalents (cannot climb 1 flight of stairs reliably).
2. Pregnancy or lactation.
3. Inability to give independent informed consent.
4. Revised cardiac risk index greater than 3.
5. Recent myocardial infarction (less than 6 weeks).
6. Recent anginal symptoms (stable or unstable) within past 6 months.
7. Recent admission or endorsement for congestive heart failure within 6 months
8. Recent admission or endorsement for syncope within 6 months.
9. Symptomatic tachy- or bradyarrhythmia (supraventricular tachcardia, ventricular tachycardia with symptoms of intermittent dizziness, pre- syncopal events)
10. Uncorrected severe valvular heart disease (severe aortic, tricuspid or mitral stenosis)
11. Acute pulmonary embolism or deep vein thrombosis (within past 6 months)
12. Uncontrolled pulmonary edema
13. Uncontrolled symptomatic cardiac arrhythmias.
14. Active endocarditis
15. Active myocarditis or pericarditis
16. Active wheezing or recent exacerbation of chronic obstructive pulmonary disease admission in past 6 months.
17. Inability to perform components of the SHAPE test (severe hip flexion limitation, severe osteoarthritis of knee or hip, limb immobilization, ambulation requires cane or crutches, baseline balance irregularities.
18. Diagnosis of symptomatic vertigo
19. Known allergic reactions to components of the SHAPE medical system apparatus disposable mouthpiece.
20. Active enrollment in an interventional clinical trial within the enrollment period of the study.

Where this trial is running

New Haven, Connecticut

• Yale University; Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)

Study contacts

• Principal investigator: Zyad J Carr, M.D. — Yale University
• Study coordinator: Zyad J Carr, M.D.

Conditions Myocardial Injury After Non-cardiac Surgery; Submaximal Exercise Performance; Preoperative Period; submaximal cardiopulmonary exercise testing; MINS; myocardial injury after noncardiac surgery; perioperative myocardial injury; anesthesiology