Clinical trial NCT05592301: Patent Foramen Ovale (PFO) and Risk of Perioperative Stroke
Official title: Canadian Patent Foramen Ovale and Perioperative Stroke Evaluation Study (CAPPRES): A Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patent Foramen Ovale
Keywords: Patent Foramen Ovale
Perioperative Stroke
Diffusion-weighted Magnetic Resonance Imaging
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Peter Munk Cardiac Centre
First posted: 2022-10-24
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients referred for an elective, non-cardiac, non-vascular and non-brain surgery

Brief summary: This is a multi-centre, prospective cohort study to determine if asymptomatic PFO is a risk factor for developing perioperative overt and covert stroke in patients undergoing non-cardiac surgery.

Detailed description: There is emerging evidence regarding the increased risk of perioperative stroke in patients with PFO, leading to an important clinical practice question: whether PFO should be considered in the perioperative risk assessment in non-cardiac surgery patients. The evidence base, however, comes from retrospective studies with numerous limitations.

Patients referred for general, orthopedic, urological, gynecologic, spinal, or thoracic surgery will be screened and consented during the surgery pre-admission clinic visit, and then undergo PFO screening using transcranial Doppler (TCD) and transthoracic echocardiography (TTE). Patients screened PFO+ (n=102) and matched PFO- controls (n=102) will have DW-MRI between postoperative days 2 and 7. Study personnel will conduct phone surveys at 30-day and 1-year post-surgery to collect data on other clinical outcomes. Patients will also be administered cognitive and patient-reported outcome measures assessments before enrollment, and 30-day and 1-year follow-up.

Eligibility 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.

Primary outcomes:
measure: Prevalence of PFO in the target (surgical) population
timeFrame: Pre-operative
measure: The incidence of perioperative stroke in patients without PFO
timeFrame: Within 30 days of surgery
measure: Study enrollment rate
timeFrame: Pre-operative
measure: Proportion of patients completing the DW-MRI test
timeFrame: 2-7 days post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, UHN
state: Ontario
Study officials:
affiliation: University Health Network, Peter Munk Cardiac Centre
name: Eric Horlick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Theta Collaborative
name: Lusine Abrahamyan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Heath Network, Division of Neurology
name: Aleksandra Pikula, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hobbes B, Akseer S, Pikula A, Huszti E, Devereaux PJ, Horlick E, Abrahamyan L. Risk of Perioperative Stroke in Patients With Patent Foramen Ovale: A Systematic Review and Meta-analysis. Can J Cardiol. 2022 Aug;38(8):1189-1200. doi: 10.1016/j.cjca.2022.02.026. Epub 2022 Mar 3.