Simple Pre-Surgery test may spot hidden heart damage
NCT ID NCT06474754
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a brief, low-intensity exercise test before noncardiac surgery could help doctors detect heart injury after surgery better than standard care. Ten adults aged 45 or older participated. Researchers measured heart injury using a blood test for up to three days after surgery and compared results to the exercise test findings. The goal was to see if the exercise test could predict or identify heart injury, which might help doctors reduce risks in the future.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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10 people
The number who actually took part.
- Started
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Mar 2025
- Finished
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Apr 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Yale University; Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
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