Cerebral Microembolization Associated With PFO Closure

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · Mar 29, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a specific condition called a patent foramen ovale (PFO) and how it relates to small blood clots that can form in the brain. The study aims to understand if these small clots, known as cerebral microemboli, happen in patients who undergo a procedure to close the PFO or an atrial septal defect (ASD). Researchers want to see if there is a link between these small clots and any blood clots that might be present in the heart.

To be eligible for the trial, participants should be between 18 and 65 years old and have documented evidence of a PFO or ASD, along with specific health conditions such as a history of stroke, transient ischemic attack (TIA), or migraines. Participants will undergo evaluations and possibly the closure procedure, with close monitoring during the study. This trial is currently recruiting participants of all genders, and it’s important for potential participants to discuss their medical history with the study team to determine eligibility.

Gender

ALL

Eligibility criteria

• • PFO group
• Inclusion Criteria:
• • 1) age 18 to 65 years; 2) documented PFO with medium-to-large shunts (≥ 20 microbubbles by c-TCD at rest or during the Valsalva maneuver); 3) history of embolic stroke (based on brain magnetic resonance imaging within 24 hours after symptom onset) or TIA within 6 months without other identifiable causes; 4) history of migraine for more than one year without other identifiable causes; 5) asymptomatic group: incidental finding of PFO in asymptomatic individuals, and presence of high-risk activities and/or anatomical features related to PFO (high-risk activities were defined as those in which the Valsalva maneuver was performed frequently or those that increased the risk of venous gas formation; and high-risk anatomical features included atrial septal aneurysm and/or curtain pattern on c-TCD).
• Exclusion Criteria:
• • 1) presence of any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity; 2) history of embolic stroke or TIA within the past one month; 3) history of deep vein thrombosis or pulmonary embolism; 4) presence of coronary artery disease and carotid artery lesions; 5) presence of coexistent cardiovascular structural malformations or diseases; 6) allergy to contrast medium; 7) refusal to participate.
• • ASD group
• Inclusion Criteria:
• • 1) age 18 to 65 years; 2) secundum ASD size 10 to 20 mm, with sufficient surrounding rims, except the aortic rim; 3) right heart catheterization: resting SPAP \< 50 mm Hg, Qp/Qs ≥ 1.5 and PVR \< 5 WU.
• Exclusion Criteria:
• • 1) presence of any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity; 2) associated with other cardiac abnormalities or diseases; 3) resting SPAP ≥50 mm Hg and resting PVR ≥5 Wood units;4) primum or sinus venosus type ASD; 5) presence of intracardiac thrombi, permanent contraindications to platelet therapy, and allergic reaction to nickel.