Clinical trial NCT04352790: Multifactorial Risk Stratification in Stroke Patients With Cardiac Disease
Official title: Multifactorial Risk Stratification in Patients With Ischemic Stroke or Transient Ischemic Attack and Structural, Inflammatory, or Arrhythmogenic Cardiac Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Cardiac Disease
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
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 878
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive ischemic stroke/transient ischemic attack patients (brain, spinal crd, or retinal) with structural, inflammatory, or arrhythmogenic cardiac disease, who are admitted to our University Hospital.

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).

Eligibility criteria: Inclusion Criteria:

* Ischemic stroke or transient ischemic attack (brain, spinal cord, or retinal)

Exclusion Criteria:

* Acute intracranial hemorrhage

Primary outcomes:
measure: Rate of any stroke
timeFrame: ≥ 12 months
Secondary outcomes:
measure: Rate of mortality
timeFrame: ≥ 12 months
measure: Rate of ischemic stroke
timeFrame: ≥ 12 months
measure: Rate of transient ischemic attack
timeFrame: ≥ 12 months
measure: Rate of systemic embolism
timeFrame: ≥ 12 months
measure: Rate of myocardial infarction
timeFrame: ≥ 12 months
measure: Rate of intracranial hemorrhage
timeFrame: ≥ 12 months
measure: Rate of major Bleedings
timeFrame: ≥ 12 months
measure: Rate of major or clinically relevant non-major bleedings
timeFrame: ≥ 12 months
measure: Rate of serious adverse events
timeFrame: ≥ 12 months
measure: Rate of new-onset atrial fibrillation
timeFrame: ≥ 12 months
measure: 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)
timeFrame: ≥ 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Poli S, Diedler J, Hartig F, Gotz N, Bauer A, Sachse T, Muller K, Muller I, Stimpfle F, Duckheim M, Steeg M, Eick C, Schreieck J, Gawaz M, Ziemann U, Zuern CS. Insertable cardiac monitors after cryptogenic stroke--a risk factor based approach to enhance the detection rate for paroxysmal atrial fibrillation. Eur J Neurol. 2016 Feb;23(2):375-81. doi: 10.1111/ene.12843. Epub 2015 Oct 16.
citation: Poli S, Siebert E, Mbroh J, Poli K, Krumbholz M, Mengel A, Greulich S, Hartig F, Muller KAL, Bocksch W, Gawaz M, Ziemann U, Zuern CS. Closure or medical therapy of patent foramen ovale in cryptogenic stroke: prospective case series. Neurol Res Pract. 2021 Apr 1;3(1):16. doi: 10.1186/s42466-021-00114-3.