Comparing two methods for assessing patent foramen ovale in stroke patients
Standardized Goal-Directed vs. Self-Directed Valsalva Maneuver for the Assessment of Patent Foramen Ovale
This study is testing if a guided breathing technique works better than a self-directed one for checking a heart condition in stroke patients to help improve diagnosis and reduce the chance of future strokes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 488 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 2 sites (Ottawa, Ontario and 1 other locations) |
| Trial ID | NCT06670781 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a standardized goal-directed Valsalva maneuver compared to a self-directed Valsalva maneuver for assessing patent foramen ovale (PFO) in patients with cryptogenic stroke. The study aims to improve the accuracy of transthoracic echocardiography (TTE) with bubble study, which is crucial for diagnosing PFO, especially in young patients. By refining the maneuver technique, the trial seeks to enhance patient outcomes and reduce the risk of recurrent strokes associated with PFO. Participants will be recruited from those referred for clinically indicated TTE and bubble studies.
Who should consider this trial
Good fit: Ideal candidates for this study are patients referred for a clinically indicated transthoracic echocardiography and bubble study due to cryptogenic stroke.
Not a fit: Patients who are unable to perform a self-directed Valsalva maneuver or cannot provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of patent foramen ovale, potentially reducing the incidence of recurrent strokes in affected patients.
How similar studies have performed: Other studies have shown success with similar approaches in improving diagnostic techniques for patent foramen ovale, indicating potential for this method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients referred for a clinically indicated TTE and bubble study Exclusion Criteria: * Inability to provide informed consent * Inability to insert an IV line * Inability to perform a Self-Directed Valsalva maneuver * Patient wishing to keep his mask on
Where this trial is running
Ottawa, Ontario and 1 other locations
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Not_yet_recruiting)
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Dr. David Messika-Zeitoun, MD — Ottawa Heart Institute Research Corporation
- Study coordinator: Dr. David Messika-Zeitoun, MD
- Email: dmessika-zeitoun@ottawaheart.ca
- Phone: 6136967337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.