Patent Foramen Ovale (PFO) and Risk of Perioperative Stroke (CAPPRES)

July 12, 2023 updated by: Eric Horlick, University Health Network, Toronto

Canadian Patent Foramen Ovale and Perioperative Stroke Evaluation Study (CAPPRES): A Feasibility Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

408

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 108 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
The Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) is used to diagnose perioperative stroke.
Diagnostic test: Transcranial Doppler (TCD)
Used to diagnose PFO
Diagnostic test: Transthoracic Echocardiogram (TTE)
Used to diagnose PFO.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of PFO in the target (surgical) population
Time Frame: Pre-operative
Identifying PFO status using TCD & TTE
Pre-operative
The incidence of perioperative stroke in patients without PFO
Time Frame: Within 30 days of surgery
Identifying perioperative stroke incidence using DW-MRI
Within 30 days of surgery
Study enrollment rate
Time Frame: Pre-operative
Establishing study enrollment rate and the reasons for refusals to participate
Pre-operative
Proportion of patients completing the DW-MRI test
Time Frame: 2-7 days post surgery
Developing mechanisms to successfully arrange the DW-MRI within a short timeframe
2-7 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Peter Munk Cardiac Centre

Investigators

  • Principal Investigator: Aleksandra Pikula, MD, University Heath Network, Division of Neurology
  • Principal Investigator: Eric Horlick, MD, University Health Network, Peter Munk Cardiac Centre
  • Principal Investigator: Lusine Abrahamyan, MD, PhD, University Health Network, Theta Collaborative

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2023

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

October 19, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (Actual)

October 24, 2022

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-5671
  • CAPPRES (Other Identifier: UHN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Patent Foramen Ovale

Clinical Trials on Diffusion-weighted Magnetic Resonance Imaging (DW-MRI)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe