Clinical trial NCT06347276: Cerebral Microembolization Associated With PFO Closure
Official title: De Novo Cerebral Microembolization Associated With Patent Foramen Ovale Closure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thrombosis Cardiac
Atrial Septal Defect
Patent Foramen Ovale (PFO)
Keywords: Patent foramen ovale; stroke; migraine; thrombus
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Beijing Anzhen Hospital
name: The Affiliated Hospital of Xuzhou Medical University
name: Tibet Autonomous Region People's Hospital
First posted: 2024-04-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In this study, there are two groups of the patients who will undergo transcatheter closure. (1) PFO patients (n=200); (2) ASD patients (n=200). Before transcatheter closure, all patients will undergo brain DW-MRI. After the transcatheter closure, DW-MRI will be performed 24 hours and 4 weeks postoperatively. In addition, the presence or absence of in situ thrombus within the PFO will be determined in patients with PFO.

Brief summary: This study aims to investigate (1) the de novo cerebral microembolization in patients who undergo transcatheter closure of PFO or ASD, and (2) evaluate the relationship between de novo cerebral microembolization and in situ thrombus within PFO.

Detailed description: Patent foramen ovale (PFO) is prevalent in the general population and it is commonly accepted that PFO is associated with various pathological conditions, including ischemic stroke, transient ischemic attack, migraines, and systemic or coronary embolization. In situ thrombus formation may play a role in patients with PFO-associated stroke or migraines. After transcatheter closure of PFO, peri-interventional cerebral embolic lesions have been detected. This study aims to investigate (1) the de novo cerebral microembolization in patients who undergo transcatheter closure of PFO or ASD, and (2) evaluate the relationship between de novo cerebral microembolization and in situ thrombus within PFO.

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.

Primary outcomes:
measure: De novo cerebral microembolization
timeFrame: 24 hours to 4 weeks after closure of PFO/ASD
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chaowu Yan
state: Beijing
Study officials:
affiliation: Cardiovascular Institute and Fuwai Hospital
name: Chaowu Yan, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yan C, Li H, Wang C, Yu H, Guo T, Wan L, Yundan P, Wang L, Fang W. Frequency and Size of In Situ Thrombus Within Patent Foramen Ovale. Stroke. 2023 May;54(5):1205-1213. doi: 10.1161/STROKEAHA.122.041524. Epub 2023 Mar 9.
citation: Yan C, Li H. Preliminary Investigation of In situ Thrombus Within Patent Foramen Ovale in Patients With and Without Stroke. JAMA. 2021 May 25;325(20):2116-2118. doi: 10.1001/jama.2021.4359.