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| ID | Type | Description | Link |
|---|---|---|---|
| CAPPRES | Other Identifier | UHN |
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| Name | Class |
|---|---|
| Peter Munk Cardiac Centre | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical patients | Patients undergoing major non-cardiac, non-vascular, and non-brain surgery who will be examined for a presence of PFO |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) | Diagnostic Test | The Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) is used to diagnose perioperative stroke. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of PFO in the target (surgical) population | Identifying PFO status using TCD & TTE | Pre-operative |
| The incidence of perioperative stroke in patients without PFO | Identifying perioperative stroke incidence using DW-MRI | Within 30 days of surgery |
| Study enrollment rate | Establishing study enrollment rate and the reasons for refusals to participate | Pre-operative |
| Proportion of patients completing the DW-MRI test | Developing mechanisms to successfully arrange the DW-MRI within a short timeframe | 2-7 days post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients referred for an elective, non-cardiac, non-vascular and non-brain surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lusine Abrahamyan, MD, PhD | Contact | 416-340-4800 | lusine.abrahamyan@uhnresearch.ca | |
| Eric Horlick, MD | Contact | 416-340-3835 | eric.horlick@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Eric Horlick, MD | University Health Network, Peter Munk Cardiac Centre | Principal Investigator |
| Lusine Abrahamyan, MD, PhD | University Health Network, Theta Collaborative | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital, UHN | Recruiting | Toronto | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35247468 | Background | 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. |
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| ID | Term |
|---|---|
| D054092 | Foramen Ovale, Patent |
| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
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| ID | Term |
|---|---|
| D038524 | Diffusion Magnetic Resonance Imaging |
| D017585 | Ultrasonography, Doppler, Transcranial |
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| Transcranial Doppler (TCD) | Diagnostic Test | Used to diagnose PFO |
|
| Transthoracic Echocardiogram (TTE) | Diagnostic Test | Used to diagnose PFO. |
|
| Aleksandra Pikula, MD | University Heath Network, Division of Neurology | Principal Investigator |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003933 | Diagnosis |
| D004453 | Echoencephalography |
| D009485 | Neuroradiography |
| D059906 | Neuroimaging |
| D011859 | Radiography |
| D014463 | Ultrasonography |
| D018608 | Ultrasonography, Doppler |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |
| D057791 | Cardiac Imaging Techniques |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |