Submaximal Cardiopulmonary Exercise Testing for Detection of Myocardial Injury After Noncardiac Surgery

Description

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.

Conditions

Myocardial Injury After Non-cardiac Surgery, Submaximal Exercise Performance, Preoperative Period

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

Submaximal Cardiopulmonary Exercise Testing for Detection of Myocardial Injury After Noncardiac Surgery

Condition
Myocardial Injury After Non-cardiac Surgery
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale University; Yale New Haven Hospital, New Haven, Connecticut, United States, 06510

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

45 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Yale University,

Zyad J Carr, M.D., PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

2026-01