Pulmonary Embolism (PE)PEaRLSNCT07519876
Pulmonary Embolism and Right-to-Left Shunts
An observational study of Pulmonary Embolism (PE) and Right-to-Left Shunt, run by Tufts Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism (PE), Right-to-Left Shunt, Stroke
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2026to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be selected from the population of patients admitted to Tufts Medical Center
Who may be able to join
- Age ≥18
- Acute pulmonary embolism (any grade/size)
- Patient or legally authorized representative is able to provide consent to participate in the study
Who cannot join
- Patients who, in the opinion of the study investigators, are unable to participate in required study activities
- Patients unable to undergo MRI imaging
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Peter J Zazzali, MS, MPH, (617) 636-8406, Peter.Zazzali@tuftsmedicine.org
David E Thaler, MD, PhD
About this study
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.
Read more
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:
- A second MRI of your brain will be performed.
- You will complete a questionnaire to evaluate whether you may have had a stroke since being discharged from the hospital
- You will meet with a member of the study team who will collect information about your health status.
- Conditions
- Pulmonary Embolism (PE), Right-to-Left Shunt, Stroke, Atrial Septal Defects, Patent Foramen Ovale (PFO), Pulmonary Arteriovenous Malformation
- Keywords
- Pulmonary Embolism, PE, Right-to-Left Shunt, PFO, ASD, Stroke, Atrial Septal Defects, Patent Foramen Ovale
- Medical subject headings
- Pulmonary Embolism, Stroke, Heart Septal Defects, Atrial, Foramen Ovale, Patent, Pulmonary Arteriovenous Fistulas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) | |
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined incidence of acute ischemic stroke and silent cerebral infarct
- 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.
- 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-weighted MRI between the screening MRI and the 90-day MRI in the absence of a relevant clinical event.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start30 Jan 2026
- Primary completion18 Feb 2026
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Embolism (PE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Occlutech International AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519876
- Sponsor's protocol ID
- STUDY00006524
- Acronym
- PEaRLS
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang M, Tan S, Patel V, Zalta BA, Shmukler A, Levsky JM, Jain VR, Shaban NM, Haramati LB. Patent foramen ovale in patients with pulmonary embolism: A prognostic factor on CT pulmonary angiography? J Cardiovasc Comput Tomogr. 2018 Jul-Aug;12(4):271-274. doi: 10.1016/j.jcct.2017.11.009. Epub 2017 Dec 2.
PubMed 29217343Vindis D, Hutyra M, Sanak D, Kral M, Cechakova E, Littnerova S, Adam T, Precek J, Hudec S, Jecmenova M, Taborsky M. Patent Foramen Ovale and the Risk of Cerebral Infarcts in Acute Pulmonary Embolism-A Prospective Observational Study. J Stroke Cerebrovasc Dis. 2018 Feb;27(2):357-364. doi: 10.1016/j.jstrokecerebrovasdis.2017.09.004. Epub 2017 Oct 12.
PubMed 29031497Tanislav C, Puille M, Pabst W, Reichenberger F, Grebe M, Nedelmann M, Kaps M, Allendorfer J. High frequency of silent pulmonary embolism in patients with cryptogenic stroke and patent foramen ovale. Stroke. 2011 Mar;42(3):822-4. doi: 10.1161/STROKEAHA.110.601575. Epub 2011 Jan 21.
PubMed 21257827Lucas TO, Schaustz EB, Dos Reis IJR, Lopes CG, Mendoca VS, Salluh JIF, Zukowski CN, Serafim RB. Risk of ischemic stroke in patients with pulmonary embolism and patent foramen ovale: A systematic review and meta-analysis. J Stroke Cerebrovasc Dis. 2025 Jan;34(1):108157. doi: 10.1016/j.jstrokecerebrovasdis.2024.108157. Epub 2024 Nov 30.
PubMed 39622459Lethen H, Flachskampf FA, Schneider R, Sliwka U, Kohn G, Noth J, Hanrath P. Frequency of deep vein thrombosis in patients with patent foramen ovale and ischemic stroke or transient ischemic attack. Am J Cardiol. 1997 Oct 15;80(8):1066-9. doi: 10.1016/s0002-9149(97)00604-8.
PubMed 9352979Le Moigne E, Timsit S, Ben Salem D, Didier R, Jobic Y, Paleiron N, Le Mao R, Joseph T, Hoffmann C, Dion A, Rousset J, Le Gal G, Lacut K, Leroyer C, Mottier D, Couturaud F. Patent Foramen Ovale and Ischemic Stroke in Patients With Pulmonary Embolism: A Prospective Cohort Study. Ann Intern Med. 2019 Jun 4;170(11):756-763. doi: 10.7326/M18-3485. Epub 2019 May 7.
PubMed 31060047Lapergue B, Decroix JP, Evrard S, Wang A, Bendetowicz D, Offroy MA, Graveleau P, Russel S, Ramdane N, Mellot F, Scherrer A, Bourdain F. Diagnostic Yield of Venous Thrombosis and Pulmonary Embolism by Combined CT Venography and Pulmonary Angiography in Patients with Cryptogenic Stroke and Patent Foramen Ovale. Eur Neurol. 2015;74(1-2):69-72. doi: 10.1159/000437261. Epub 2015 Jul 25.
PubMed 26228469Konstantinides S, Geibel A, Kasper W, Olschewski M, Blumel L, Just H. Patent foramen ovale is an important predictor of adverse outcome in patients with major pulmonary embolism. Circulation. 1998 May 19;97(19):1946-51. doi: 10.1161/01.cir.97.19.1946.
PubMed 9609088Kasper W, Geibel A, Tiede N, Just H. Patent foramen ovale in patients with haemodynamically significant pulmonary embolism. Lancet. 1992 Sep 5;340(8819):561-4. doi: 10.1016/0140-6736(92)92102-l.
PubMed 1355152Goliszek S, Wisniewska M, Kurnicka K, Lichodziejewska B, Ciurzynski M, Kostrubiec M, Golebiowski M, Babiuch M, Paczynska M, Koc M, Palczewski P, Wyzgal A, Pruszczyk P. Patent foramen ovale increases the risk of acute ischemic stroke in patients with acute pulmonary embolism leading to right ventricular dysfunction. Thromb Res. 2014 Nov;134(5):1052-6. doi: 10.1016/j.thromres.2014.09.013. Epub 2014 Sep 21.
PubMed 25282541Doyen D, Castellani M, Moceri P, Chiche O, Lazdunski R, Bertora D, Cerboni P, Chaussade C, Ferrari E. Patent foramen ovale and stroke in intermediate-risk pulmonary embolism. Chest. 2014 Oct;146(4):967-973. doi: 10.1378/chest.14-0100.
PubMed 24874409Clergeau MR, Hamon M, Morello R, Saloux E, Viader F, Hamon M. Silent cerebral infarcts in patients with pulmonary embolism and a patent foramen ovale: a prospective diffusion-weighted MRI study. Stroke. 2009 Dec;40(12):3758-62. doi: 10.1161/STROKEAHA.109.559898. Epub 2009 Sep 24.
PubMed 19797184Beckman MG, Hooper WC, Critchley SE, Ortel TL. Venous thromboembolism: a public health concern. Am J Prev Med. 2010 Apr;38(4 Suppl):S495-501. doi: 10.1016/j.amepre.2009.12.017.
PubMed 20331949
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Embolism and Right-to-Left Shunts
- ClinicalTrials.gov ID
- NCT07519876
- Acronym / sponsor ID
- PEaRLS / STUDY00006524
- Conditions
- Pulmonary Embolism (PE), Right-to-Left Shunt, Stroke, Atrial Septal Defects, Patent Foramen Ovale (PFO), Pulmonary Arteriovenous Malformation
- Keywords
- Pulmonary Embolism, PE, Right-to-Left Shunt, PFO, ASD, Stroke, Atrial Septal Defects, Patent Foramen Ovale
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Occlutech International AB
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 18 Feb 2026 (actual)
- Study completion
- Jan 2028 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- A second MRI of your brain will be performed.
- You will complete a questionnaire to evaluate whether you may have had a stroke since being discharged from the hospital
- You will meet with a member of the study team who will collect information about your health status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be selected from the population of patients admitted to Tufts Medical Center
Key inclusion criteria (3 listed)
- Age ≥18
- Acute pulmonary embolism (any grade/size)
- Patient or legally authorized representative is able to provide consent to participate in the study
Key exclusion criteria (2 listed)
- Patients who, in the opinion of the study investigators, are unable to participate in required study activities
- Patients unable to undergo MRI imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Combined incidence of acute ischemic stroke and silent cerebral infarct
Time frame: 90 Days
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-weighted MRI between the screening MRI and the 90-day MRI in the absence of a relevant clinical event.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 29217343Zhang M, Tan S, Patel V, Zalta BA, Shmukler A, Levsky JM, Jain VR, Shaban NM, Haramati LB. Patent foramen ovale in patients with pulmonary embolism: A prognostic factor on CT pulmonary angiography? J Cardiovasc Comput Tomogr. 2018 Jul-Aug;12(4):271-274. doi: 10.1016/j.jcct.2017.11.009. Epub 2017 Dec 2.
- Background: PubMed 29031497Vindis D, Hutyra M, Sanak D, Kral M, Cechakova E, Littnerova S, Adam T, Precek J, Hudec S, Jecmenova M, Taborsky M. Patent Foramen Ovale and the Risk of Cerebral Infarcts in Acute Pulmonary Embolism-A Prospective Observational Study. J Stroke Cerebrovasc Dis. 2018 Feb;27(2):357-364. doi: 10.1016/j.jstrokecerebrovasdis.2017.09.004. Epub 2017 Oct 12.
- Background: PubMed 21257827Tanislav C, Puille M, Pabst W, Reichenberger F, Grebe M, Nedelmann M, Kaps M, Allendorfer J. High frequency of silent pulmonary embolism in patients with cryptogenic stroke and patent foramen ovale. Stroke. 2011 Mar;42(3):822-4. doi: 10.1161/STROKEAHA.110.601575. Epub 2011 Jan 21.
- Background: PubMed 39622459Lucas TO, Schaustz EB, Dos Reis IJR, Lopes CG, Mendoca VS, Salluh JIF, Zukowski CN, Serafim RB. Risk of ischemic stroke in patients with pulmonary embolism and patent foramen ovale: A systematic review and meta-analysis. J Stroke Cerebrovasc Dis. 2025 Jan;34(1):108157. doi: 10.1016/j.jstrokecerebrovasdis.2024.108157. Epub 2024 Nov 30.
- Background: PubMed 9352979Lethen H, Flachskampf FA, Schneider R, Sliwka U, Kohn G, Noth J, Hanrath P. Frequency of deep vein thrombosis in patients with patent foramen ovale and ischemic stroke or transient ischemic attack. Am J Cardiol. 1997 Oct 15;80(8):1066-9. doi: 10.1016/s0002-9149(97)00604-8.
- Background: PubMed 31060047Le Moigne E, Timsit S, Ben Salem D, Didier R, Jobic Y, Paleiron N, Le Mao R, Joseph T, Hoffmann C, Dion A, Rousset J, Le Gal G, Lacut K, Leroyer C, Mottier D, Couturaud F. Patent Foramen Ovale and Ischemic Stroke in Patients With Pulmonary Embolism: A Prospective Cohort Study. Ann Intern Med. 2019 Jun 4;170(11):756-763. doi: 10.7326/M18-3485. Epub 2019 May 7.
- Background: PubMed 26228469Lapergue B, Decroix JP, Evrard S, Wang A, Bendetowicz D, Offroy MA, Graveleau P, Russel S, Ramdane N, Mellot F, Scherrer A, Bourdain F. Diagnostic Yield of Venous Thrombosis and Pulmonary Embolism by Combined CT Venography and Pulmonary Angiography in Patients with Cryptogenic Stroke and Patent Foramen Ovale. Eur Neurol. 2015;74(1-2):69-72. doi: 10.1159/000437261. Epub 2015 Jul 25.
- Background: PubMed 9609088Konstantinides S, Geibel A, Kasper W, Olschewski M, Blumel L, Just H. Patent foramen ovale is an important predictor of adverse outcome in patients with major pulmonary embolism. Circulation. 1998 May 19;97(19):1946-51. doi: 10.1161/01.cir.97.19.1946.
- Background: PubMed 1355152Kasper W, Geibel A, Tiede N, Just H. Patent foramen ovale in patients with haemodynamically significant pulmonary embolism. Lancet. 1992 Sep 5;340(8819):561-4. doi: 10.1016/0140-6736(92)92102-l.
- Background: PubMed 25282541Goliszek S, Wisniewska M, Kurnicka K, Lichodziejewska B, Ciurzynski M, Kostrubiec M, Golebiowski M, Babiuch M, Paczynska M, Koc M, Palczewski P, Wyzgal A, Pruszczyk P. Patent foramen ovale increases the risk of acute ischemic stroke in patients with acute pulmonary embolism leading to right ventricular dysfunction. Thromb Res. 2014 Nov;134(5):1052-6. doi: 10.1016/j.thromres.2014.09.013. Epub 2014 Sep 21.
- Background: PubMed 24874409Doyen D, Castellani M, Moceri P, Chiche O, Lazdunski R, Bertora D, Cerboni P, Chaussade C, Ferrari E. Patent foramen ovale and stroke in intermediate-risk pulmonary embolism. Chest. 2014 Oct;146(4):967-973. doi: 10.1378/chest.14-0100.
- Background: PubMed 19797184Clergeau MR, Hamon M, Morello R, Saloux E, Viader F, Hamon M. Silent cerebral infarcts in patients with pulmonary embolism and a patent foramen ovale: a prospective diffusion-weighted MRI study. Stroke. 2009 Dec;40(12):3758-62. doi: 10.1161/STROKEAHA.109.559898. Epub 2009 Sep 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism (PE) and Right-to-Left Shunt, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined incidence of acute ischemic stroke and silent cerebral infarct (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07519876, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.