跳至主要内容
临床试验/NCT06156670
NCT06156670招募中不适用

Russian Registry of Endovascular Closure of Patent Foramen Ovale

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
700
试验地点
1
主要终点
Efficacy and safety of endovascular closure of a PFO

研究概览

简要总结

The study will include all patients over 18 years of age who underwent endovascular closure of patent foramen ovale in medical centers in the Russian Federation, who gave written informed consent to the closure and provided personal data as part of inpatient medical care. The project participants will be 29 medical centers in the Russian Federation, where endovascular closure of patent foramen ovale is performed.

详细描述

Ischemic stroke is the fifth most common cause of death and the leading cause of disability among adult patients worldwide. Cryptogenic stroke is a very broad term that applies in cases of incomplete evaluation, with multiple "competing" causes, and in situations where the cause could not be identified during evaluation. This type of stroke has been termed embolic stroke from an undetermined source, or ESUS (Embolic Stroke of Undetermined Source). Possible causes of ESUS include cardiopathies, including isolated atrial myocardial damage, atherosclerotic lesions of the extra- and intracranial arteries and aortic arch (these 3 causes are the most common), as well as patent foramen ovale (PFO), heart defects, oncology, and concealed atrial fibrillation. According to a 2015 observational study by LiL. et al. approximately one third of all ischemic strokes are considered cryptogenic. An important contribution to the development of cryptogenic stroke according to the data of a number of authors is made by an unenlarged patent foramen ovale (PFO). Once the relationship between the development of cryptogenic stroke and the PFO is established, the stroke is considered to be PFO-associated.

According to the literature, the incidence of a PFO in adult patients ranges from 20% to 35%. The distinguishing feature of a PFO from an interatrial septal defect is impaired fusion of the primary and secondary septum, rather than a deficiency.

There are various theories for the development of cryptogenic stroke in patients with a PFO. The most popular is the presence and migration of thrombus from the inferior vena cava system: predominantly the veins of the lower extremities, but also the pelvic veins. It is also possible to develop thrombus in the PFO channel due to the change from laminar to turbulent blood flow directly in the tunnel of the unclosed PFO. This mechanism of cryptogenic stroke development is more theoretical and is not currently confirmed by the literature.

In addition to the development of cryptogenic strokes in patients with a PFO there is a risk of thromboembolism of other organs and systems. According to the literature, thrombus migration through the PFO may be the cause of occlusion of arteries of the intestine, lower and upper extremities. Clinical cases of thrombus migration through PFO have been described, which led to occlusion of coronary arteries and development of acute myocardial infarction with ST-segment elevation.

In the presence of cryptogenic stroke or other thromboembolism in patients with an unclosed PFO, the contribution of the PFO to the development of vascular catastrophe is evaluated. The Risk of Paradoxal Embolism (RoPE) scale was created. A high total score on the scale indicates a high probability of a relationship between PFO and cryptogenic stroke. The scale is a simple tool for clinicians, but in the European Society of Cardiology consensus document on the treatment of patients with PFO, even a low score on this scale is not a contraindication for endovascular treatment of patients with PFO.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with an ischemic event (cryptogenic ischemic stroke, transient ischemic attack, embolism of other organs and systems) associated with a PFO;
  • Presence of an open oval confirmed by ultrasound diagnostic methods;
  • Age of patients from 18 years;
  • Life expectancy of at least 1 year;
  • Signed informed consent for endovascular closure of a PFO.

排除标准

  • Inability to receive antiplatelet therapy;
  • Presence of acute inflammatory diseases;
  • Acute stage of cerebral circulatory failure (30 days);
  • Myocardial infarction or aortocoronary bypass surgery within the previous 30 days;
  • Carotid or vertebral artery dissection;
  • Severe cardiac valve pathology;
  • Presence of blood clots in the cardiac cavities;
  • Refusal of the patient to participate in the study.

结局指标

主要结局

Efficacy and safety of endovascular closure of a PFO

时间窗: 12 month

To evaluate the efficacy and safety of endovascular closure of a PFO in Russia,

Baseline clinical and demographic characteristics

时间窗: 12 month

To describe the baseline clinical and demographic characteristics of patients with PFO who underwent its closure in Russia

次要结局

  • Procedural success rate of endovascular closure of PFO(12 month)

研究者

发起方
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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