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Assessing Stroke Risk During Surgery for Patent Foramen Ovale (CAPPRES Trial)

N/A

Recruiting

Led By Eric Horlick, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

With an estimated hospital length of stay ≥2 days

Referred for an elective, non-cardiac, non-vascular and non-brain surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-7 days post surgery

Awards & highlights

CAPPRES Trial Summary

This trial looks at whether a heart defect raises the risk of stroke during surgery.

Who is the study for?

This study is for adults over 18 who are scheduled for elective non-cardiac, non-vascular, and non-brain surgeries with a hospital stay of at least 2 days. It includes general, orthopedic, urological, gynecologic, spinal or thoracic surgeries. People on long-term blood thinners or those with conditions that raise stroke risk can't join.Check my eligibility

What is being tested?

The trial is investigating if having an asymptomatic PFO increases the risk of strokes around the time of surgery. Participants will undergo special imaging tests like DW-MRI and TCD to monitor their brain health before and after surgery.See study design

What are the potential side effects?

Since this trial involves diagnostic procedures rather than medications, side effects may include discomfort during testing or reactions to MRI contrast agents if used (like mild pain or skin changes at the injection site).

CAPPRES Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am expected to stay in the hospital for 2 days or more.

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I am scheduled for surgery that is not related to my heart, blood vessels, or brain.

CAPPRES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Prevalence of PFO in the target (surgical) population

Magnetic Resonance Imaging

Study enrollment rate

+1 more

CAPPRES Trial Design

1Treatment groups

Experimental Treatment

Group I: Surgical patientsExperimental Treatment3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Doppler (TCD)

2012

N/A

~160

Transthoracic Echocardiogram (TTE)

2016

N/A

~100

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

484,772 Total Patients Enrolled

Peter Munk Cardiac CentreUNKNOWN

1 Previous Clinical Trials

500 Total Patients Enrolled

Eric Horlick, MDPrincipal InvestigatorUniversity Health Network, Peter Munk Cardiac Centre

2 Previous Clinical Trials

9,060 Total Patients Enrolled

Media Library

Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) Clinical Trial Eligibility Overview. Trial Name: NCT05592301 — N/A

Patent Foramen Ovale Research Study Groups: Surgical patients

Patent Foramen Ovale Clinical Trial 2023: Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) Highlights & Side Effects. Trial Name: NCT05592301 — N/A

Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05592301 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial include elderly individuals in its participant pool?

"This clinical trial is seeking participants aged between 18 and 110 years old."

Answered by AI

Are there currently any openings in this experimental research?

"Affirmative. According to the information made available on clinicaltrials.gov, this medical trial is presently seeking participants. It was initially posted on July 7th 2023 and most recently adjusted on July 12th 2023; with a goal of recruiting up to 408 patients from a single site."

Answered by AI

Do I meet the criteria to join in this medical experiment?

"The study is accepting 408 individuals, aged 18 to 110, who have been diagnosed with patent foramen ovale. In addition to this requirement, all participants must be eighteen or older and expected to stay in the hospital post-surgery for at least two days. People referred for general surgery as well as orthopedic, urological, gynecological, spinal and thoracic operations are eligible."

Answered by AI

How many research participants are currently accepted into this experiment?

"Affirmative. According to clinicaltrials.gov, the trial was posted on July 7th 2023 and subsequently edited on July 12th of the same year. It is currently looking for 408 participants from 1 major medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Patent Foramen Ovale (PFO) and Risk of Perioperative Stroke

Eric Horlick 2023. "Patent Foramen Ovale (PFO) and Risk of Perioperative Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05592301.