Anticoagulants for PFO Patients

Capital Medical University

Status

Completed

Conditions

Patent Foramen Ovale

Treatments

Procedure: PFO closure

Drug: anticoagulant

Study type

Observational

Funder types

Other

Identifiers

NCT06375070

RMeng1

Details and patient eligibility

About

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.

Enrollment

277 patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

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.