Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke, Transient Ischemic Attack. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this observational study is to * to investigate the prevalence and time course of autonomic dysfunction in acute ischemic stroke patients; * to evaluate the influence of lesion location on autonomic dysfunction; * to identify patterns of structural and functional brain connectivity within the central autonomic control circuits associated with autonomic dysfunction; and * to explore causal models of the link between brain lesions; cardiac, immunological and endocrine biomarkers; and dysautonomia. Researchers will compare patients with acute ischemic stroke to patients with transient ischemic attacks to study the effect of acute ischemic brain lesions. Participants will * undergo cardiovascular autonomic function testing; * receive structural and functional MR imaging; * provide blood samples for determinaton of serological biomarkers auf dysautonomia.
Primary outcome measures
- Autonomic dysfunction [Time frame: 3-5 days after stroke onset]
Secondary outcome measures (1)
- Autonomic dysfunction [Time frame: 90 days after stroke onset]
Eligibility criteria
Inclusion criteria
- Diagnosis of either
- acute ischemic stroke with either an ischemic lesion visible on CT/MRI or persistent focal deficits 24 hours after symptom onset, or
- Transient ischemic attack with transient clinical deficits including motor or speech disturbance and not restricted to isolated vertigo/dizziness, visual disturbance, or sensory disturbance.
- symptom onset within 72h prior to hospital admission,
- a pre-stroke/TIA ability to walk without help from another person (modified Rankin scale score < 4),
- age > 18 years, and
- informed consent by either the patient or a legal representative (including a spouse)
Exclusion criteria
- In-hospital stroke,
- contraindications to MR imaging (e.g., claustrophobia, pregnancy, pacemakers, implants),
- known moderate to severe dementia,
- previous structural brain damage (except leukoariosis due to cerebral small vessel disease),
- hemodynamically relevant stenosis of the common or internal carotid artery, or
- left heart failure with estimated left ventricular ejection fraction < 50%,
- concomitant systemic illness that can lead to dysautonomia, such as an active infection, thyroid disease, or neurodegenerative disorder (e.g. PD, MSA).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Medical Center Hamburg-Eppendorf — Hamburg
Identifiers
NCT: NCT06740942 · 118914145