CardioLogical Interventions and Acute strOke Treatment sTudy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- CLOT-R primary outcome - Stroke severity
研究概览
简要总结
The study aims to investigate characteristics and prognosis of ischemic stroke cases following cardiological interventions, focusing on the effectiveness and safety of acute ischemic stroke treatments.
详细描述
CLOT is a multicenter, observational, ambispective real-world study involving acute ischemic stroke cases occuring after cardiological procedures.
Patients will be recruited at different emergency services and stroke units in Europe. The study will encompass a retrospective (CLOT-R) and prospective (CLOT-P) data collection.
CLOT-R will include cases the occured in the 5 years befor the initation of the study; CLOT-P has a duration of 2 years of enrollement from the study approval at each site and follow-up of 180 days (total duration of 2 years and 180 days). The inclusion criteria are: acute ischemic stroke in adult patient (18 years of age or older) as diagnosed according to the World Health Organization (WHO) criteria; stroke with evidence of CT/MRI DWI/FLAIR acute lesion in the first neuroimaging or in the follow-up at 24-48 h; interventional cardiological procedures performed within 28 days since the stroke onset (Percutaneuous Coronary Intervention - PCI, Transcatheter Aortic Valve Replacement - TAVR, Baloon Aortic Valvuloplasy - BAV, Percutaneous Mitral Valve Repair or Replacement, Patent Formaen Ovale - PFO - or Atrial Septal Defects - ASD - Closure, Left Atrial Appendage Closure, Transcatheter Pulmonary Valve Replacement, Percutaneous Closure of Paravalvular Leaks); written informed consent provided by the patient himself or by proxy (for unconscious patients, cognitively impaired, or aphasic).
Exclusion criteria are: Stroke-like symptoms due primarily to another non-ischemic/hemorrhagic acute neurological condition or stroke mimics (e.g. severe hypo- or hyperglycemia, migraine with aura, functional disorders, etc); Spontaneous and post traumatic hemorrhagic stroke or spontaneous/post-traumatic subarachnoid hemorrhage or subdural hematoma; Impossibility to achieve written informed consent.
The primary outcome of CLOT-R is a descriptive analysis of baseline demographic, clinical, neuroimaging, cardiological procedural and acute stroke treatment characteristics. The secondary outcomes are: effectiveness and safety of intravenous thrombolysis (IVT) with or without mechanical thrombectomy (MT), or MT alone; 90-day post-stroke risk of all-cause and vascular mortality, new ischemic stroke or transient ischemic attack (TIA), myocardial infarction, intracranial hemorrhage or other major bleeding events, disability as measured by the modified Rankin Scale (mRS) score.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute ischemic stroke in adult patient (18 years of age or older) as diagnosed according to the World Health Organization (WHO) criteria;
- •stroke with evidence of CT/MRI DWI/FLAIR acute lesion in the first neuroimaging or in the follow-up at 24-48 h;
- •interventional cardiological procedures performed within 28 days since the stroke onset (Percutaneuous Coronary Intervention - PCI, Transcatheter Aortic Valve Replacement - TAVR, Baloon Aortic Valvuloplasy - BAV, Percutaneous Mitral Valve Repair or Replacement, Patent Formaen Ovale - PFO - or Atrial Septal Defects - ASD - Closure, Left Atrial Appendage Closure, Transcatheter Pulmonary Valve Replacement, Percutaneous Closure of Paravalvular Leaks);
- •written informed consent provided by the patient himself or by proxy (for unconscious patients, cognitively impaired, or aphasic).
排除标准
- •Stroke-like symptoms due primarily to another non-ischemic/hemorrhagic acute neurological condition or stroke mimics (e.g. severe hypo- or hyperglycemia, migraine with aura, functional disorders, etc);
- •Spontaneous and post traumatic hemorrhagic stroke or spontaneous/post-traumatic subarachnoid hemorrhage or subdural hematoma;
- •AciuImpossibility to achieve written informed consent
研究组 & 干预措施
Patients with ischemic stroke occuring within 28 days after cardiological interventional procedures
Cardiological interventions includes: Percutaneuous Coronary Intervention - PCI, Transcatheter Aortic Valve Replacement - TAVR, Baloon Aortic Valvuloplasy - BAV, Percutaneous Mitral Valve Repair or Replacement, Patent Formaen Ovale - PFO - or Atrial Septal Defects - ASD - Closure, Left Atrial Appendage Closure, Transcatheter Pulmonary Valve Replacement, Percutaneous Closure of Paravalvular Leaks
结局指标
主要结局
CLOT-R primary outcome - Stroke severity
时间窗: from enrollment to 180 days follow-up
Stroke severity assessed via the National Institutes of Health Stroke Scale (NIHSS). Scores on the NIHSS range from 0 to 42, with higher scores indicating more severe neurological deficits.
CLOT-R primary outcome - Radiology
时间窗: from enrollment to 180-day follow-up
Number of participants with large vessel occlusion demonstrated on neuroimaging.
CLOT-R primary outcome - Cardiological procedure
时间窗: from enrollment to 180-day follow-up
Number of participants who underwent cardiological procedures during which ischemic stroke occurred.
CLOT-P primary outcome - Efficacy
时间窗: 90-day follow-up
Number of participants presenting with Modified Rankin Scale (mRS) score ≤2 after revascularization. Scores on the mRS range from 0 to 6, with 0 indicating no symptoms and 6 indicating death. A score of 2 or less indicates functional indipendence.
CLOT-P primary outcome - safety
时间窗: 90-day follow-up
Number of participants with symptomatic intracranial hemorrhage after revascularization.
次要结局
- CLOT-R secondary outcome - Efficacy(90-day follow-up)
- CLOT-R secondary outcome - Safety(90-day follow-up)
- CLOT-R secondary outcome: Serious Adverse Event (SAE)(90-day follow-up)
- CLOT-P secondary outcome: Serious Adverse Event (SAE)(90-day and 180-day follow-up)
研究者
Simona Sacco
Full Professor of Neurology
University of L'Aquila