Status:
NOT_YET_RECRUITING
Prediction and Prevention of Postoperative Mortality and Morbidity
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Alzheimer Disease
Alzheimer Disease Related Dementias
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
This study will contribute to creating a prospective and robust automated preoperative risk assessment algorithm for 30-day mortality, major adverse cardiac and cerebrovascular events (MACCE) and peri...
Detailed Description
This study will cover the following two specific aims: Aim 1. A randomized controlled trial (RCT) to assess the effectiveness of pre-operative personalized prehabilitation with proactive cognitive an...
Eligibility Criteria
Inclusion
- Part I
- 65 years of age and older
- Identified as higher risk (≥2.5%) for 30-day mortality and MACCE based on the UPMC's Perioperative Model (EHR risk prediction algorithm)
- Scheduled for major cardiac surgeries including coronary artery bypass and valvular repair and/or vascular surgeries including carotid endarterectomy, aortic aneurysm repair, and major vascular surgeries
- RAI score ≥ 30
- PHQ-9 score ≥ 5
- Anticipated length of stay \> 3 days
- Informed consent
- English speaking patients
- All races and ethnicities
- Diverse background (education, area deprivation index)
- Part II
- Patients undergoing high-risk cardiac and vascular surgery, such as intraoperative bypass for cardiac surgeries and carotid endarterectomy/ aortic aneurysm vascular surgeries.
- History of fully resolved stroke and TIA without any residual weakness
- Significant carotid artery stenosis (defined as \>70% unilateral or bilateral stenosis)
- Moderate and high risk for mortality based on Society of Thoracic Surgery score (score \>4)
- Enrolled in Part 1, "Randomized controlled clinical trial to assess the effectiveness of preoperative personalized prehabilitation as well as cognitive and behavioral interventions on reducing postoperative delirium (POD), postoperative cognitive dysfunction (POCD), dementia, 30-day major adverse cardiac and cerebrovascular events (MACCE) and mortality in high-risk surgical patients (≥65y)."
- Part I
Exclusion
- Children (\<18 years)
- Patients unable to provide consent
- MoCA score \<23
- Persistent weakness from prior cerebrovascular accident
- Patients with severe preoperative medical diseases, blindness or significant visual impairment, unresolved motor weakness, or any other perioperative events or complications that would have a bearing on the patients' ability to perform study tasks, neuropsychological tests and proposed interventions
- Part II
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT06042413
Start Date
January 1 2026
End Date
September 1 2026
Last Update
November 19 2025
Active Locations (1)
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1
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213