Patent Foramen Ovale (PFO) and Risk of Perioperative Stroke

NCT05592301 | Unknown DMC

• 2 other identifiers: 21-5671CAPPRES
• Study Type: observational
• Target: 408
• Locations: 1 country
• Sites: 1

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.

Conditions

Patent Foramen Ovale

Keywords

Patent Foramen Ovale; Perioperative Stroke; Diffusion-weighted Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Surgical patients

Patients undergoing major non-cardiac, non-vascular, and non-brain surgery who will be examined for a presence of PFO

Diagnostic Test: Diffusion-weighted Magnetic Resonance Imaging (DW-MRI); Diagnostic Test: Transcranial Doppler (TCD); Diagnostic Test: Transthoracic Echocardiogram (TTE)

Interventions

Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) DIAGNOSTIC_TEST

The Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) is used to diagnose perioperative stroke.

Surgical patients

Transcranial Doppler (TCD) DIAGNOSTIC_TEST

Used to diagnose PFO

Surgical patients

Transthoracic Echocardiogram (TTE) DIAGNOSTIC_TEST

Used to diagnose PFO.

Surgical patients

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients referred for an elective, non-cardiac, non-vascular and non-brain surgery

You may qualify if:

• patients 18 years and above;
• referred for an elective, non-cardiac, non-vascular and non-brain surgery;
• with an estimated hospital length of stay ≥2 days. We will include patients referred for general, orthopedic, urological, gynecologic, spinal or thoracic surgery.

You may not qualify if:

• patients in need for long-term, perioperative anticoagulants;
• those with comorbidities that potentially increase the risk of perioperative stroke;
• contraindications to MRI;
• unable to complete or adhere to the study.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Peter Munk Cardiac Centre: collaborator

Study Sites (1)

Toronto General Hospital, UHN

Toronto, Ontario, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 35247468 BACKGROUND

MeSH Terms

Conditions

Foramen Ovale, Patent

Interventions

Diffusion Magnetic Resonance Imaging; Ultrasonography, Doppler, Transcranial; Echocardiography

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Echoencephalography; Neuroradiography; Neuroimaging; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques; Cardiac Imaging Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Eric Horlick, MD

  University Health Network, Peter Munk Cardiac Centre

  PRINCIPAL INVESTIGATOR

• Lusine Abrahamyan, MD, PhD

  University Health Network, Theta Collaborative

  PRINCIPAL INVESTIGATOR

• Aleksandra Pikula, MD

  University Heath Network, Division of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lusine Abrahamyan, MD, PhD

CONTACT

416-340-4800; lusine.abrahamyan@uhnresearch.ca

Eric Horlick, MD

CONTACT

416-340-3835; eric.horlick@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Structural Heart Disease

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 24, 2022
• Study Start: July 7, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)