Multifactorial Risk Stratification in Patients With Ischemic Stroke or Transient Ischemic Attack and Structural, Inflammatory, or Arrhythmogenic Cardiac Disease
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 878
- Primary Endpoint
- Rate of any stroke
Study Overview
Brief Summary
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
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ischemic stroke or transient ischemic attack (brain, spinal cord, or retinal)
Exclusion Criteria
- •Acute intracranial hemorrhage
Outcomes
Primary Outcomes
Rate of any stroke
Time Frame: ≥ 12 months
Recurrent ischemic stroke or intracranial hemorrhage during follow-up
Secondary Outcomes
- Rate of mortality(≥ 12 months)
- Rate of systemic embolism(≥ 12 months)
- Rate of myocardial infarction(≥ 12 months)
- Rate of intracranial hemorrhage(≥ 12 months)
- Rate of serious adverse events(≥ 12 months)
- Rate of new-onset atrial fibrillation(≥ 12 months)
- Rate of ischemic stroke(≥ 12 months)
- Rate of transient ischemic attack(≥ 12 months)
- Rate of major Bleedings(≥ 12 months)
- Rate of major or clinically relevant non-major bleedings(≥ 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)(≥ 12 months)