RECRUITING

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

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-30

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06474754

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.

Ages Eligible for Study:45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Zyad J Carr, M.D.

CONTACT

203-785-3689

zyad.carr@yale.edu

Principal Investigator

Zyad J Carr, M.D.

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale University; Yale New Haven Hospital

New Haven, Connecticut, 06510

United States

Collaborators and Investigators

Sponsor: Yale University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-30

Study Completion Date2026-01

Study Record Updates

Study Start Date2025-03-30

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

submaximal cardiopulmonary exercise testing
MINS
myocardial injury after noncardiac surgery
perioperative myocardial injury
anesthesiology

Additional Relevant MeSH Terms

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