Study of Stroke Risk in Adults with Pulmonary Embolism and Right-to-Left Heart or Lung Openings

What this Trial Is About

Researchers are investigating whether people who have had a pulmonary embolism PE and also have a right-to-left shunt RLS in their heart or lungs are at higher risk of stroke compared to those without an RLS. A right-to-left shunt is an opening that allows blood clots to pass from veins to arteries, which can cause a stroke. This study observes and compares stroke-related outcomes in these two groups to better understand the risks involved. Participants will be grouped based on whether they have an RLS or not, identified by a transcranial Doppler TCD ultrasound with bubble study or previous testing. The study lasts about 90 days and includes brain magnetic resonance imaging MRI scans shortly after enrollment and at a 90-day follow-up. During the follow-up visit, participants will complete a questionnaire about possible stroke symptoms and meet with the study team for health status updates. Throughout the study, medical records will be reviewed to collect information such as age, sex, race, medical history, and medications. The main outcome measured is the combined incidence of acute ischemic stroke and silent cerebral infarcts within 90 days. Safety monitoring includes the MRIs and health questionnaires to track stroke or other health changes. Participation involves two brain scans, health assessments, and medical record reviews over the study period.

Pulmonary Embolism and Right-to-Left Shunts