Patent foramen ovale in patients with pulmonary embolism: A prognostic factor on CT pulmonary angiography?
Meng Zhang, Stephanie Tan, Vishal Patel...
https://pubmed.ncbi.nlm.nih.gov/29217343Actively Recruiting
Age: 18Years +
All Genders
ID07519876
Pulmonary Embolism and Right-to-Left Shunts Observational Study to Assess Stroke Risk
Led by Tufts Medical Center · Updated on 2026-04-09
256
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
Sponsors
T
Tufts Medical Center
Lead Sponsor
O
Occlutech International AB
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Pulmonary Embolism and Right-to-Left Shunts
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Acute pulmonary embolism of any grade or size
- Able to provide consent to participate in the study
You will not qualify if you...
- Unable to participate in required study activities as determined by investigators
- Unable to undergo MRI imaging
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Up to enrollment
Participants undergo tests to identify the presence or absence of a right-to-left shunt using transcranial Doppler (TCD) with bubble study or previous investigations.
1 to 2 visits depending on previous testing
Long-term Monitoring
Duration - 90 days
Participants are observed for the occurrence of acute ischemic stroke and silent cerebral infarct over the study period.
Periodic assessments during monitoring
Trial Site Locations
Total: 1 location
1
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Patent Foramen Ovale and the Risk of Cerebral Infarcts in Acute Pulmonary Embolism-A Prospective Observational Study.
David Vindiš, Martin Hutyra, Daniel Šaňák...
https://pubmed.ncbi.nlm.nih.gov/29031497High frequency of silent pulmonary embolism in patients with cryptogenic stroke and patent foramen ovale.
Christian Tanislav, Maximilian Puille, Wolfgang Pabst...
https://pubmed.ncbi.nlm.nih.gov/21257827Risk of ischemic stroke in patients with pulmonary embolism and patent foramen ovale: A systematic review and meta-analysis.
Tiago O Lucas, Eduardo B Schaustz, Isabelle J R Dos Reis...
https://pubmed.ncbi.nlm.nih.gov/39622459Frequency of deep vein thrombosis in patients with patent foramen ovale and ischemic stroke or transient ischemic attack.
H Lethen, F A Flachskampf, R Schneider...
https://pubmed.ncbi.nlm.nih.gov/9352979Patent Foramen Ovale and Ischemic Stroke in Patients With Pulmonary Embolism: A Prospective Cohort Study.
Emmanuelle Le Moigne, Serge Timsit, Douraied Ben Salem...
https://pubmed.ncbi.nlm.nih.gov/31060047Diagnostic Yield of Venous Thrombosis and Pulmonary Embolism by Combined CT Venography and Pulmonary Angiography in Patients with Cryptogenic Stroke and Patent Foramen Ovale.
Bertrand Lapergue, Jean Pierre Decroix, Serge Evrard...
https://pubmed.ncbi.nlm.nih.gov/26228469Patent foramen ovale is an important predictor of adverse outcome in patients with major pulmonary embolism.
S Konstantinides, A Geibel, W Kasper...
https://pubmed.ncbi.nlm.nih.gov/9609088Patent foramen ovale in patients with haemodynamically significant pulmonary embolism.
W Kasper, A Geibel, N Tiede...
https://pubmed.ncbi.nlm.nih.gov/1355152Patent foramen ovale increases the risk of acute ischemic stroke in patients with acute pulmonary embolism leading to right ventricular dysfunction.
Sylwia Goliszek, Małgorzata Wiśniewska, Katarzyna Kurnicka...
https://pubmed.ncbi.nlm.nih.gov/25282541