Actively Recruiting
SHAPE Test for Preoperative Risk Stratification
Led by Yale University · Updated on 2026-05-07
371
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is looking at whether a simplified exercise test called the SHAPE-HF cardiopulmonary testing system can be used before surgery in older adults. Doctors often need to know how well a patient's heart, lungs, and body handle physical activity before moderate- to high-risk surgery. This information may help them better understand a patient's fitness for surgery and possible risk of complications afterward. The study will enroll adults older than 60 years who are being evaluated before planned moderate- to high-risk noncardiac surgery. The first goal is to determine if this was feasible in older adults and to learn whether patients can be successfully recruited to complete this pre-surgery test. Secondly, the study will also look at how results from the SHAPE-HF system compare with common ways doctors now estimate fitness, such as asking patients about their physical activity and using a standard questionnaire. Participants will attend one in-person study visit lasting about 35 minutes. During that visit, they will answer questions about their activity level and complete testing with the SHAPE-HF system. The test uses short periods of lower-intensity exercise to estimate aerobic fitness. After the visit, participants will be contacted by phone about 24 hours later to check for any problems related to the study test. Lastly, researchers will also review information from the medical record for 30 days after surgery to see whether test results are related to recovery, short-term health problems after surgery, or major complications. No extra surgery or change in planned medical care is part of this study. The information learned may help improve how doctors evaluate older adults before surgery in the future.
CONDITIONS
Official Title
SHAPE Test for Preoperative Risk Stratification
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged over 60 years
- Scheduled for pre-surgical evaluation for moderate to high-risk surgery
- Revised Cardiac Risk Index (RCRI) less than 2
- Signed and dated informed consent provided
You will not qualify if you...
- Under 60 years of age
- Self-reported functional capacity below 4 METs
- Unable to provide independent informed consent
- Revised Cardiac Risk Index (RCRI) greater than 2
- Neurological impairment with motor limitations
- Mental impairment preventing cooperation
- Recent myocardial infarction within 6 months
- Angina within 6 months
- Uncorrected severe valvular heart disease
- Recent congestive heart failure exacerbation requiring hospitalization within 6 months
- Acute pulmonary embolism or deep vein thrombosis within 6 months
- Uncontrolled pulmonary edema
- Uncontrolled symptomatic arrhythmias
- Active endocarditis
- Acute myocarditis or pericarditis
- Active wheezing or home oxygen use
- Recent exacerbation of COPD, asthma, or pneumonia requiring hospitalization within 6 months
- Inability to perform SHAPE test components due to physical limitations
- Diagnosis of vertigo
- Known allergy to SHAPE system mouthpiece components
- Active enrollment in another interventional clinical trial during study period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
Z
Zyad J Carr, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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