Submaximal Cardiopulmonary Exercise Testing for Detection of Myocardial Injury After Noncardiac Surgery
Enhancing Precise Perioperative Risk Surveillance: Validation of Submaximal Cardiopulmonary Exercise Testing to Usual Care for Detection of Myocardial Injury After Noncardiac Surgery
Yale University
61 participants
Mar 30, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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.
Exclusion Criteria20
- 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.
- Symptomatic tachy- or bradyarrhythmia (supraventricular tachcardia, ventricular tachycardia with symptoms of intermittent dizziness, pre- syncopal events)
- Uncorrected severe valvular heart disease (severe aortic, tricuspid or mitral stenosis)
- Acute pulmonary embolism or deep vein thrombosis (within past 6 months)
- Uncontrolled pulmonary edema
- Uncontrolled symptomatic cardiac arrhythmias.
- Active endocarditis
- Active myocarditis or pericarditis
- Active wheezing or recent exacerbation of chronic obstructive pulmonary disease admission in past 6 months.
- 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.
- Diagnosis of symptomatic vertigo
- Known allergic reactions to components of the SHAPE medical system apparatus disposable mouthpiece.
- Active enrollment in an interventional clinical trial within the enrollment period of the study.
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Interventions
A serum derived measure of myocardial injury. Threshold value of 14ng/L.
FDA-approved device uses breath by breath sampling during calibration and exercise challenge. Analysis is performed using a differential pressure pneumotach method for volume calibration and measurement, an infrared sensor for CO2 and a paramagnetic sensor for O2 measurements. Automated calibration using a calibration gas mixture (15.6% O2/5% CO2) is performed at regular intervals. The Shape II calculations used to differentiate causes of exertional dyspnea are Artificial Intelligence (AI) based algorithms and measurements have been previously validated to conventional cardiopulmonary exercise testing methods. Brief smCPET is comprised of a 2-minute calibration phase, 3 minutes of graded exercise using a stair-step and a 1 minute recovery phase for a total of 6 minutes. An instant report is then generated.
A validated measure of preoperative functional capacity which will be utilized to cross-validate smCPET peak VO2. Low DASI score has been found to estimate peak oxygen uptake (VO2), predict MINS, myocardial infarction, and inducible myocardial ischemia on myocardial perfusion scintigraphy.
Locations(1)
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NCT06474754