Assessing the risk of stroke in patients with a heart condition during surgery
Canadian Patent Foramen Ovale and Perioperative Stroke Evaluation Study (CAPPRES): A Feasibility Study
This study is trying to see if having a small hole in the heart called Patent Foramen Ovale (PFO) makes people more likely to have a stroke during non-heart surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 408 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05592301 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine if asymptomatic Patent Foramen Ovale (PFO) increases the risk of perioperative stroke in patients undergoing non-cardiac surgeries. Patients will be screened for PFO using transcranial Doppler and transthoracic echocardiography, with those identified as PFO positive compared to matched controls. Following surgery, diffusion-weighted MRI will be performed to assess any stroke occurrences, and follow-up surveys will evaluate clinical outcomes and cognitive function at 30 days and 1 year post-surgery. The study seeks to provide clearer evidence on the role of PFO in perioperative risk assessment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective non-cardiac surgeries with a hospital stay of at least two days.
Not a fit: Patients requiring long-term anticoagulants or those with significant comorbidities that increase stroke risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for patients with PFO undergoing non-cardiac surgery.
How similar studies have performed: While there is emerging evidence regarding PFO and stroke risk, this study aims to address limitations in previous retrospective studies, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. patients 18 years and above; 2. referred for an elective, non-cardiac, non-vascular and non-brain surgery; 3. with an estimated hospital length of stay ≥2 days. We will include patients referred for general, orthopedic, urological, gynecologic, spinal or thoracic surgery. Exclusion Criteria: 1. patients in need for long-term, perioperative anticoagulants; 2. those with comorbidities that potentially increase the risk of perioperative stroke; 3. contraindications to MRI; 4. unable to complete or adhere to the study.
Where this trial is running
Toronto, Ontario
- Toronto General Hospital, UHN — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Eric Horlick, MD — University Health Network, Peter Munk Cardiac Centre
- Study coordinator: Lusine Abrahamyan, MD, PhD
- Email: lusine.abrahamyan@uhnresearch.ca
- Phone: 416-340-4800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.