Pulmonary embolism with right-to-left heart or lung shunts
Pulmonary Embolism and Right-to-Left Shunts
Tufts Medical Center · NCT07519876
This project will see if people with an acute pulmonary embolism who also have a right-to-left shunt (like a PFO or ASD) are more likely to have a stroke than PE patients without a shunt.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 256 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tufts Medical Center (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07519876 on ClinicalTrials.gov |
What this trial studies
This is an observational study enrolling adults with acute pulmonary embolism to determine whether a concurrent right-to-left shunt (RLS) increases the short-term risk of stroke. Participants will be characterized for RLS (for example PFO, ASD, or pulmonary AVM) using appropriate imaging and clinical tests and then followed for stroke outcomes. The study compares stroke rates between PE patients with and without an identified RLS without altering standard clinical care. Data collection occurs at Tufts Medical Center with collaborators contributing device/diagnostic expertise.
Who should consider this trial
Good fit: Adults aged 18 or older with an acute pulmonary embolism who can provide consent and can undergo required imaging (such as MRI) are ideal candidates.
Not a fit: Patients who cannot undergo MRI, are unable to participate in required study activities, or who do not have a pulmonary embolism would not be expected to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help doctors identify PE patients at higher risk of paradoxical stroke and guide decisions about monitoring or targeted treatments.
How similar studies have performed: Previous research links PFOs to paradoxical embolic stroke, but studies specifically examining stroke risk from RLS in the setting of acute PE are limited and results have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 2. Acute pulmonary embolism (any grade/size) 3. Patient or legally authorized representative is able to provide consent to participate in the study Exclusion Criteria: 1. Patients who, in the opinion of the study investigators, are unable to participate in required study activities 2. Patients unable to undergo MRI imaging
Where this trial is running
Boston, Massachusetts
- Tufts Medical Center — Boston, Massachusetts, United States (RECRUITING)
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.
Conditions: Pulmonary Embolism, Right-to-Left Shunt, Stroke, Atrial Septal Defects, Patent Foramen Ovale, Pulmonary Arteriovenous Malformation, PE, PFO