Anticoagulants for PFO Patients

Completed

• Conditions: Patent Foramen Ovale
• Interventions: Procedure: PFO closure; Drug: anticoagulant

• Registration Number: NCT06375070
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Primary Completion: 2022-08
• Study Completion: 2022-08
• Status Verified: 2024-04
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-16
• Study First Posted: 2024-04-19
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 277

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
large-shunt Group	PFO closure	\>30 bubbles
moderate-shunt Group	PFO closure	(10-30 bubbles)
small-shunt Group	PFO closure	small (3-9 bubbles)
small-shunt Group	anticoagulant	small (3-9 bubbles)
moderate-shunt Group	anticoagulant	(10-30 bubbles)
large-shunt Group	anticoagulant	\>30 bubbles

Primary Outcome Measures

Name	Time	Method
whether occur recurrent stroke or migraine relief	12 months