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Идёт набор NCT06347276

Cerebral Microembolization Associated With PFO Closure

— Наблюдательное Thrombosis Cardiac Atrial Septal Defect Patent Foramen Ovale (PFO)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: PFO occluder; ASD occluder.
Кому может быть актуально
Состояния в реестре: Thrombosis Cardiac, Atrial Septal Defect, Patent Foramen Ovale (PFO). Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

De Novo Cerebral Microembolization Associated With Patent Foramen Ovale Closure

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство PFO occluder; ASD occluder
    Transcatheter closure of atrial septal defect (ASD) and patent foramen ovale (PFO) All cases will be examined with DW-MRI preoperatively, and DW-MRI will be repeated 24 hours and 4 weeks after the transcatheter closure procedure.

Первичные конечные точки

  • De novo cerebral microembolization [Срок оценки: 24 hours to 4 weeks after closure of PFO/ASD]

Критерии участия

PFO group

Критерии включения

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).

Критерии исключения

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

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Chaowu Yan — Пекин

Публикации

  • 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. PMID 36891906
  • 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. PMID 34032839

Идентификаторы

NCT: NCT06347276 · 2023-RW320-08

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗