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Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke

Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06740942
Acronym
ARIADNE
Enrollment
100
Registered
2024-12-18
Start date
2025-08-04
Completion date
2026-12-01
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke, Transient Ischemic Attack

Keywords

Autonomic dysfunction, cardiovascular dysregulation, brain-heart axis, stroke-heart syndrome, acute ischemic stroke, transient ischemic attack, autonomic function test, central autonomic network, network lesion mapping, lesion symptom mapping, resting-state fMRI, functional brain network, structural brain network, diffusion tensor imaging

Brief 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.

Interventions

None listed

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Autonomic dysfunction3-5 days after stroke onsetCardiovagal and Adrenergic Scores on the Composite Autonomic Scoring Scale (0-7, higher values indicate greater dysfunction)

Secondary

MeasureTime frameDescription
Autonomic dysfunction90 days after stroke onsetCardiovagal and Adrenergic Scores on the Composite Autonomic Scoring Scale (0-7, higher values indicate greater dysfunction)

Countries

Germany

Contacts

CONTACTEckhard Schlemm
e.schlemm@uke.de+49 152 228 98447
CONTACTThies Ingwersen
thi.ingwersen@uke.de+49 152 228 34568

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026