SHAPE Test for Preoperative Risk Stratification

Study acronym: SHAPEPAT
StatusActive, Not Recruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 6 months later May 29, 2026 → Nov 29, 2026
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Record History

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  1. Notable Primary and study completion pushed from May 29, 2026 to Nov 29, 2026 Show 4 more changesShow less
    • Enrollment closed, study ongoing
    • Site details revised
    • Publications: details revised at 16 of 18 entries
    • Eligibility criteria expanded, about 5 words
  2. Minor Re-verified, no change to tracked fieldsv10
  3. Minor Study description expanded, about 399 wordsv9
  4. Notable Enrollment target: 200 to 371v8
  5. Notable Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 100 to 200
    • Site details revised
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Notable Primary and study completion dates: May 29, 2024 to May 29, 2026
    • Trial status: Completed to Active, Not Recruiting
    v6
  2. Minor Trial status: Recruiting to Completed
    • Primary completion date changed from estimate of Jan 2025 to May 29, 2024
    • Study completion date changed from estimate of Mar 2025 to May 29, 2024
    • Site details revised
    v5
  3. Minor Re-verified, no change to tracked fieldsv4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2023 to May 3, 2023
    v3
  5. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
490 trials monitored
See 31 trials at risk
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.
Trial Details
NCT Number NCT05743673
Lead Sponsor Yale University
Conditions
(from sponsor)
Perioperative/Postoperative Complications, Aerobic Capacity
Related terms Postoperative Complications
Enrollment 371 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov