Patent Foramen OvaleNCT06375070
Anticoagulants for PFO Patients
An observational study of Patent Foramen Ovale, run by Xuanwu Hospital, Beijing.
Trial summary
Patients who underwent both bubble transcranial Doppler (bubble-TCD) and transoesophageal echocardiography (TEE) at our institution were consecutively enrolled in this real-world case-control study from August 2016 through August 2023. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Patent Foramen Ovale
- What is being tested?
- PFO closure and anticoagulant
- Type of treatment
- Surgery or procedure
- How many people
- 277 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Aug 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Eligible participants had their PFO diagnosis confirmed via transoesophageal echocardiography (TEE), bubble transcranial Doppler (Bubble-TCD), or contrast echocardiography of the right heart and gave their informed consent to participate
Who may be able to join
- verified PFO diagnosis through TEE, Bubble-TCD, or contrast echocardiography of the right heart;
- ages range between 16 and 65;
- no restrictions on sexual orientation;
- stroke patients with cryptogenic strokes as per the TOAST classification;
- no other likely causes for migraines, with the exception of PFO;
- no multiple risk factors for cerebrovascular disease, such as hypertension, diabetes, or smoking.
Who cannot join
- 1)severe, acute, or life-threatening conditions including acute cardio-cerebrovascular diseases, significant organ failure, or infections; 2)magnetic resonance imaging (MRI) contraindications, especially with contrast enhancement; 3) presence of cerebral artery stenosis, internal carotid artery stenosis, or atherosclerosis; 4) hypercoagulability or venous thrombosis; 5) contraindications associated with PFO closure and anticoagulants; 6) obstructive sleep apnea.
About this study
Patients who underwent both bubble transcranial Doppler (bubble-TCD) and transoesophageal echocardiography (TEE) at our institution were consecutively enrolled in this real-world case-control study from August 2016 through August 2023. The patients were categorized into three groups based on the degree of the shunt observed: mild (3-9 bubbles), moderate (10-30bubbles), and severe (more than 30 bubbles). In cases with mild-shunt (small-size) PFO, post-procedural anticoagulation or PFO closure was administered. Subsequent to the interventions, the follow-up encompassed the recording of migraine remission, recurrent neurological incidents, instances of major bleeding, and mortality.
- Conditions
- Patent Foramen Ovale
- Being tested
- PFO closure, anticoagulant
- Keywords
- patent foramen ovale, migraine, stroke
- Medical subject headings
- Foramen Ovale, Patent, Migraine Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFO closureProcedure or surgery
PFO closure
anticoagulantDrug
rivaroxaban
| Study group | Role | What they receive |
|---|---|---|
| small-shunt Group | small (3-9 bubbles) Receives: Procedure: PFO closure; Drug: anticoagulant | |
| moderate-shunt Group | (10-30 bubbles) Receives: Procedure: PFO closure; Drug: anticoagulant | |
| large-shunt Group | >30 bubbles Receives: Procedure: PFO closure; Drug: anticoagulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
whether occur recurrent stroke or migraine relief
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study startAug 2016
- Primary completionAug 2022
- Study completionAug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Foramen OvaleStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 277 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375070
- Sponsor's protocol ID
- RMeng1
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulants for PFO Patients
- ClinicalTrials.gov ID
- NCT06375070
- Acronym / sponsor ID
- RMeng1
- Conditions
- Patent Foramen Ovale
- Keywords
- patent foramen ovale, migraine, stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2022 (actual)
- Study completion
- Aug 2022 (actual)
- First posted
- 19 Apr 2024 (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.
Patients who underwent both bubble transcranial Doppler (bubble-TCD) and transoesophageal echocardiography (TEE) at our institution were consecutively enrolled in this real-world case-control study from August 2016 through August 2023. The patients were categorized into three groups based on the degree of the shunt observed: mild (3-9 bubbles), moderate (10-30bubbles), and severe (more than 30 bubbles). In cases with mild-shunt (small-size) PFO, post-procedural anticoagulation or PFO closure was administered. Subsequent to the interventions, the follow-up encompassed the recording of migraine remission, recurrent neurological incidents, instances of major bleeding, and mortality.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| small-shunt Group | – | Procedure: PFO closure, Drug: anticoagulantsmall (3-9 bubbles) |
| moderate-shunt Group | – | Procedure: PFO closure, Drug: anticoagulant(10-30 bubbles) |
| large-shunt Group | – | Procedure: PFO closure, Drug: anticoagulant>30 bubbles |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible participants had their PFO diagnosis confirmed via transoesophageal echocardiography (TEE), bubble transcranial Doppler (Bubble-TCD), or contrast echocardiography of the right heart and gave their informed consent to participate
Key inclusion criteria (6 listed)
- verified PFO diagnosis through TEE, Bubble-TCD, or contrast echocardiography of the right heart;
- ages range between 16 and 65;
- no restrictions on sexual orientation;
- stroke patients with cryptogenic strokes as per the TOAST classification;
- no other likely causes for migraines, with the exception of PFO;
Key exclusion criteria (1 listed)
- 1)severe, acute, or life-threatening conditions including acute cardio-cerebrovascular diseases, significant organ failure, or infections; 2)magnetic resonance imaging (MRI) contraindications, especially with contrast enhancement; 3) presence of cerebral artery stenosis, internal carotid artery stenosis, or atherosclerosis; 4) hypercoagulability or venous thrombosis; 5) contraindications associated with PFO closure and anticoagulants; 6) obstructive sleep apnea.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFO closurePFO closure | Procedure or surgery | large-shunt Group, moderate-shunt Group, small-shunt Group |
| anticoagulantrivaroxaban | Drug | large-shunt Group, moderate-shunt Group, small-shunt Group |
Primary outcome
whether occur recurrent stroke or migraine relief
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Foramen Ovale, run by Xuanwu Hospital, Beijing.
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
whether occur recurrent stroke or migraine relief (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2024.