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NCT Number: NCT06740942

Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

Location status: Recruiting

Location contact

Eckhard Schlemm

CONTACT

[email protected]

0049 152 229 98447

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Autonomic dysfunction

    Time frame: 3-5 days after stroke onset

    Cardiovagal and Adrenergic Scores on the Composite Autonomic Scoring Scale (0-7, higher values indicate greater dysfunction)

Secondary outcomes

  1. Autonomic dysfunction

    Time frame: 90 days after stroke onset

    Cardiovagal and Adrenergic Scores on the Composite Autonomic Scoring Scale (0-7, higher values indicate greater dysfunction)

Study contacts

Contact information is provided by the study sponsor or research team.

Eckhard Schlemm

CONTACT

[email protected]

+49 152 228 98447

Thies Ingwersen

CONTACT

[email protected]

+49 152 228 34568

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Acronym: ARIADNE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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