NCT07519876 Pulmonary Embolism and Right-to-Left Shunts
| NCT ID | NCT07519876 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tufts Medical Center |
| Condition | Pulmonary Embolism (PE) |
| Study Type | OBSERVATIONAL |
| Enrollment | 256 participants |
| Start Date | 2026-01-30 |
| Primary Completion | 2026-02-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 256 participants in total. It began in 2026-01-30 with a primary completion date of 2026-02-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07519876 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Embolism (PE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07519876 currently recruiting?
Yes, NCT07519876 is actively recruiting participants. Visit ClinicalTrials.gov or contact Tufts Medical Center to inquire about joining.
Where is the NCT07519876 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07519876 clinical trial?
NCT07519876 is sponsored by Tufts Medical Center. The trial plans to enroll 256 participants.