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NCT07519876 · ClinicalTrials.gov registry record
Pulmonary Embolism and Right-to-Left Shunts
A clinical trial, sponsored by Tufts Medical Center.
- Recruiting
- Registry status
- 256
- Enrollment target
NCT07519876: Recruiting study, sponsored by Tufts Medical Center.
NCT07519876 is a clinical trial that is actively recruiting participants, run by Tufts Medical Center. The registered enrollment target is 256 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07519876 is actively recruiting participants, sponsored by Tufts Medical Center.
- RECRUITING
- Registry status
- 256 participants
- Enrollment target
Study 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
Primary Outcome
1. Acute ischemic stroke incidence through 90 days defined as an acute focal neurological deficit presumed to be due to focal cerebral or retinal ischemia and either: a) Persisting \>24 hours b) Persisting \<24 hours but associated with a neuroanatomically relevant cerebral or retinal infarct documented with MRI or CT or direct retinal observation. 2. Silent cerebral infarct through 90 days defined as the presence of at least one new hyperintense lesion of 3 mm or greater in diameter on T2-weigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2026-01-30 |
| Est. Completion | 2028-01 |
What NCT07519876 shows while recruiting
NCT07519876 is an observational study that tracks outcomes without assigning an intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT07519876 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07519876 about?
NCT07519876 is a clinical study titled "Pulmonary Embolism and Right-to-Left Shunts". 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 poss...
What is the current status of trial NCT07519876?
This trial is currently recruiting. The enrollment target is 256 participants. The study started on 2026-01-30. Estimated completion is 2028-01.
Who is sponsoring clinical trial NCT07519876?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
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