Patent Foramen Ovale Clinical Trial
NCT number | NCT06375070 |
Other study ID # | RMeng1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | August 2022 |
Verified date | April 2024 |
Source | Xuanwu Hospital, Beijing |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 277 |
Est. completion date | August 2022 |
Est. primary completion date | August 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. verified PFO diagnosis through TEE, Bubble-TCD, or contrast echocardiography of the right heart; 2. ages range between 16 and 65; 3. no restrictions on sexual orientation; 4. stroke patients with cryptogenic strokes as per the TOAST classification; 5. no other likely causes for migraines, with the exception of PFO; 6. no multiple risk factors for cerebrovascular disease, such as hypertension, diabetes, or smoking. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | whether occur recurrent stroke or migraine relief | 12 months |
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