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.
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).
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
Acute ischemic stroke in adult patient (\>18 years old) after cardiological intervention, male and female.
Cohort
Other
Not listed
CLOT-R primary outcome - Stroke severity
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
Number of participants with large vessel occlusion demonstrated on neuroimaging.
CLOT-R primary outcome - Cardiological procedure
Number of participants who underwent cardiological procedures during which ischemic stroke occurred.
CLOT-P primary outcome - Efficacy
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-R secondary outcome - Efficacy
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-R secondary outcome - Safety
Number of patients with symptomatic intracranial hemorrhage after revascularization.
CLOT-R secondary outcome: Serious Adverse Event (SAE)
Number of patients experiencing Serious Adverse Events (retrospective investigation).
CLOT-P secondary outcome: Serious Adverse Event (SAE)
Number of patients experiencing Serious Adverse Events (prospective investigation).
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University of L'Aquila
Lead sponsor
Rete delle NeuroCardiologie
Collaborator
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