Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05592301
Study type Observational
Source University Health Network, Toronto
Contact Lusine Abrahamyan, MD, PhD
Phone 416-340-4800
Email lusine.abrahamyan@uhnresearch.ca
Status Recruiting
Phase
Start date July 7, 2023
Completion date July 1, 2025

See also
  Status Clinical Trial Phase
Completed NCT06192173 - Patent Foramen Ovale Closure in Migraine
Recruiting NCT04610463 - Evaluation of the Severity of Right to Left Shunt in PFO Patients After Systemic Embolism N/A
Completed NCT02882815 - Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale) Occluder N/A
Completed NCT04604015 - RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt N/A
Active, not recruiting NCT04950192 - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Not yet recruiting NCT04549272 - Assessment of Early Vascular Damage With Advanced Neuroimaging in Patient With Patent Foramen Ovale
Completed NCT02621528 - Lifetech CeraFlex™ Post-Market Surveillance Study N/A
Terminated NCT01018355 - The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI N/A
Completed NCT00831259 - Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO) N/A
Not yet recruiting NCT05360771 - Study on the Safety and Effectiveness of the SnowyTM PFO Closure System N/A
Recruiting NCT05546320 - Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale Phase 4
Recruiting NCT05561660 - COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2) Phase 4
Completed NCT03904277 - Does Patent Foramen Ovale Size Matter in Men and Women
Recruiting NCT06120270 - CeraFlex PFO Closure System PMCF Study
Terminated NCT01773252 - Right to Left Cardiac Shunt Detection Phase 3
Completed NCT01216423 - Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale N/A
Completed NCT03377465 - Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis N/A
Active, not recruiting NCT04738071 - International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
Not yet recruiting NCT06413147 - Long-term Procedural and Device Related Complications of PFO Closure
Not yet recruiting NCT06344494 - Cardiac Interventional ICE Imaging Trial N/A