Multifactorial Risk Stratification in Stroke Patients With Cardiac Disease

Study Overview
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Brief Summary
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Prospective registry for multifactorial risk factor assessment, enrolling consecutive ischemic stroke/transient ischemic attack patients with structural, inflammatory, or arrhythmogenic cardiac disease, who are admitted to our University Hospital.

Detailed Description
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The prospective registry shall provide new insights into the multiple associations, and respective therapeutic implications of cardio-vascular risk factors and stroke. For that reason consecutive patients with ischemic stroke/transient ischemic attack (brain, spinal cord, or retinal) and structural (e.g. patent foramen ovale), septic or aseptic endocarditis or myocarditis, or supra-ventricular or ventricular arrhythmia, who are admitted to our University Hospital, are enrolled. Multifactorial assessment of risk factors is based on medical history, laboratory biomarkers, electrocardiogram incl. cardiac autonomic function analysis, and (long-term) cardiac rhythm monitoring, as well as transthoracic and transesophageal echocardiography. Inclusion of follow-up visits permit longitudinal and prognostic evaluation of routine diagnostic and therapeutic interventions for secondary stroke prevention (e.g. implantable loop recorders or interventional closure of patent foramen ovale).

Official Title
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Multifactorial Risk Stratification in Patients With Ischemic Stroke or Transient Ischemic Attack and Structural, Inflammatory, or Arrhythmogenic Cardiac Disease

Conditions
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Stroke, Cardiac Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic stroke or transient ischemic attack (brain, spinal cord, or retinal) Exclusion Criteria: Acute intracranial hemorrhage

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of any stroke | Recurrent ischemic stroke or intracranial hemorrhage during follow-up | ≥ 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of mortality | Death from any cause during follow-up | ≥ 12 months | 
| Rate of ischemic stroke | Ischemic stroke recurrence during follow-up | ≥ 12 months | 
| Rate of transient ischemic attack | Transient ischemic attack recurrence during follow-up | ≥ 12 months | 
| Rate of systemic embolism | Systemic embolism during follow-up | ≥ 12 months | 
| Rate of myocardial infarction | Myocardial infarction during follow-up | ≥ 12 months | 
| Rate of intracranial hemorrhage | Intracranial hemorrhage during follow-up | ≥ 12 months | 
| Rate of major Bleedings | Major Bleedings during follow-up | ≥ 12 months | 
| Rate of major or clinically relevant non-major bleedings | Major or clinically relevant non-major bleedings during follow-up | ≥ 12 months | 
| Rate of serious adverse events | Serious adverse events during follow-up | ≥ 12 months | 
| Rate of new-onset atrial fibrillation | Detection of atrial fibrillation during follow-up | ≥ 12 months | 
| modified Rankin Score; range from 0 to 6, with '0' indicating the best outcome (i.e. no deficit), and '6' the worst outcome (i.e. death) | modified Rankin Scale score at follow-up | ≥ 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patent foramen ovale, loop recorder, atrial fibrillation, heart rhythm monitoring, autonomic dysfunction, cryptogenic stroke, embolic stroke of undetermined source, ESUS, transient ischemic attack, retinal ischemia