Pulmonary Embolism and Right-to-Left Shunts

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tufts Medical Center
Study ID
NCT07519876
Status
Recruiting
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Conditions

  • Atrial Septal Defects
  • Patent Foramen Ovale (PFO)
  • Pulmonary Arteriovenous Malformation
  • Pulmonary Embolism (PE)
  • Right-to-Left Shunt
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

Every fetus has a small hole in their heart, called a foramen ovale when they are developing in the womb. For most people this hole closes shortly after birth, but it doesn't close completely in 1 out of every 4 people. This is called a "patent" foramen ovale, or PFO. In people with a PFO it is possible for a blood clot in a vein to enter the heart, pass through the opening, and then go into an artery - this is referred to as a paradoxical embolism which passes through a "Right-to-Left Shunt," or RLS. If this occurs, the blood clot can cause a stroke. The most common RLS (more than 90%) is a PFO. Much rarer causes include other types of holes in the heart (like an atrial septal defect, or ASD), or a vascular communication in the lungs (like a pulmonary arteriovenous malformation, or AVM). We are investigating whether people with a PE are at higher risk of stroke if they happen to have an RLS compared to PE patients who don't have an RLS. This study will simply observe and compare the differences in stroke-related outcomes between those 2 groups. Participation in the study last roughly 90-days and includes the following activities: * The study team will review your medical records to collect general information such as your age, sex, race/ethnicity, height, weight, medications, medical history, and other medical information * Magnetic Resonance Imaging (MRI) of your brain will be done as soon as possible following your enrollment in the study. For more information on MRI scans, please see the "MRI scan" section below. * A Transcranial Doppler (TCD) with bubble study will be performed to determine if an opening is present in your heart or lungs. TCD is performed using ultrasound. A contrast called agitated saline will be injected into your vein for this test. * You will be asked to return for a follow-up visit 90 days after your pulmonary embolism. At this visit, the following will occur: 1. A second MRI of your brain will be performed. 2. You will complete a questionnaire to evaluate whether you may have had a stroke since being discharged from the hospital 3. You will meet with a member of the study team who will collect information about your health status.

Key Dates

Start date
Jan 30, 2026
Status verified
Apr 2026
Primary completion
Feb 18, 2026
Completion
Jan 31, 2028

Study Design

Enrollment
256 participants (estimated)

Arms

  • Arm: Right-to-Left Shunt (RLS)
    The RLS cohort includes: a) Subjects found to have a right-to-left shunt (RLS) using transcranial Doppler (TCD) with bubble study b) Subjects with a known RLS (i.e. previously investigated with TCD or TEE)
  • Arm: No Right-to-Left Shunt (No RLS)
    The No RLS cohort includes: a) Subjects with no RLS identified via TCD with bubble study b) Subjects known to not have an RLS (i.e. previously investigated with TCD or TEE)

Primary Outcome Measure

Combined incidence of acute ischemic stroke and silent cerebral infarct [ Time Frame: 90 Days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Tufts Medical CenterBostonMassachusetts02111
Peter J Zazzali, MS, MPH
[email protected]
(617) 636-8406
David E Thaler, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Tufts Medical Center· Boston, MA

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