Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT05592301

Conditions

Patent Foramen Ovale

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Diffusion-weighted Magnetic Resonance Imaging (DW-MRI)

Transcranial Doppler (TCD)

Transthoracic Echocardiogram (TTE)

Study Details

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

Study ID

NCT05592301

Start date

Jul 7, 2023

Status verified date

Jul, 2023

Completion date

Jul 1, 2025

Anticipated

Primary completion date

Jul 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

408 participants

Anticipated

Interventions and Outcome Measures

Arms

Surgical patients

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

Interventions

Diffusion-weighted Magnetic Resonance Imaging (DW-MRI)

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

Transcranial Doppler (TCD)

Used to diagnose PFO

Transthoracic Echocardiogram (TTE)

Used to diagnose PFO.

Primary outcome measure

  • Prevalence of PFO in the target (surgical) population [ Time Frame: Pre-operative ]
  • The incidence of perioperative stroke in patients without PFO [ Time Frame: Within 30 days of surgery ]
  • Study enrollment rate [ Time Frame: Pre-operative ]
  • Proportion of patients completing the DW-MRI test [ Time Frame: 2-7 days post surgery ]

Central Contacts and Locations

Central contacts

Lusine Abrahamyan, MD, PhD

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

Eric Horlick, MD

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

Locations

Toronto General Hospital, UHN

Recruiting

Toronto, Ontario, Canada

Contacts

Lusine Abrahamyan, MD

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

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jul 17, 2023

Last verified

Jul, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2023-07-17.