Enhancing Precise Perioperative Risk Surveillance: Validation of Submaximal Cardiopulmonary Exercise Testing to Usual Care for Detection of Myocardial Injury After Noncardiac Surgery
Yale University
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.
Description
Among the 50 million US adults undergo non-cardiac surgery each year, an estimated 1.4-3.9% of patients experience perioperative myocardial infarction with another 6-18% showing evidence of myocardial injury. These cardiac insults, known as myocardial injury after noncardiac surgery (MINS) are associated with a 2.7-3.2 fold higher odds of 30-day mortality, 2.2 fold higher odds of nonfatal myocardial infarction (MI), 1.55 fold increase in 30-day congestive heart failure events, and 5.2 times higher risk of stroke, highlighting the importance of predicting and treating their occurrence. MINS is…
Eligibility
- Age range
- 45+ years
- Sex
- All
- Healthy volunteers
- Yes
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 surge…
Interventions
- Diagnostic TestHigh-sensitivity troponin, serum
A serum derived measure of myocardial injury. Threshold value of 14ng/L.
- Diagnostic TestSubmaximal Cardiopulmonary Exercise Testing
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.
- Diagnostic TestDuke Activity Status Index
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.
Location
- Yale University; Yale New Haven HospitalNew Haven, Connecticut