Cardiac Disease, Stroke
Conditions
Keywords
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
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).
Interventions
None listed
Sponsors
University Hospital Tuebingen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ischemic stroke or transient ischemic attack (brain, spinal cord, or retinal)
Exclusion criteria
* Acute intracranial hemorrhage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of any stroke | ≥ 12 months | Recurrent ischemic stroke or intracranial hemorrhage during follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of myocardial infarction | ≥ 12 months | Myocardial infarction during follow-up |
| Rate of intracranial hemorrhage | ≥ 12 months | Intracranial hemorrhage during follow-up |
| Rate of mortality | ≥ 12 months | Death from any cause during follow-up |
| Rate of ischemic stroke | ≥ 12 months | Ischemic stroke recurrence during follow-up |
| Rate of transient ischemic attack | ≥ 12 months | Transient ischemic attack recurrence during follow-up |
| Rate of systemic embolism | ≥ 12 months | Systemic embolism during follow-up |
| Rate of major or clinically relevant non-major bleedings | ≥ 12 months | Major or clinically relevant non-major bleedings during follow-up |
| Rate of serious adverse events | ≥ 12 months | Serious adverse events during follow-up |
| Rate of new-onset atrial fibrillation | ≥ 12 months | Detection of atrial fibrillation during follow-up |
| 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 | modified Rankin Scale score at follow-up |
| Rate of major Bleedings | ≥ 12 months | Major Bleedings during follow-up |
Outcome results
None listed