RecruitingNot Applicable

Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke

Germany100 participantsStarted 2025-08-04

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Autonomic dysfunction

Timeframe: 3-5 days after stroke onset

Trial details

NCT IDNCT06740942

SponsorUniversitätsklinikum Hamburg-Eppendorf

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09

Contact for this trial

Eckhard Schlemm

+49 152 228 98447 e.schlemm@uke.de

View on ClinicalTrials.gov More Acute Ischemic Stroke trials