Clinical trial

RMeng1

Name
RMeng1
Description
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.
Trial arms
Trial start
2016-08-01
Estimated PCD
2022-08-01
Trial end
2022-08-01
Status
Completed
Treatment
PFO closure
PFO closure
Arms:
large-shunt Group, moderate-shunt Group, small-shunt Group
anticoagulant
rivaroxaban
Arms:
large-shunt Group, moderate-shunt Group, small-shunt Group
Size
277
Primary endpoint
whether occur recurrent stroke or migraine relief
12 months
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '12 Months', 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 277, 'type': 'ACTUAL'}}
Updated at
2024-04-19

1 organization

1 product

1 indication

Organization
Xuanwu Hospital