Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke (ARIADNE)

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.

Study Overview

• Status: Recruiting
• Conditions: Transient Ischemic Attack; Acute Ischemic Stroke

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Eckhard Schlemm; Phone Number: +49 152 228 98447; Email: e.schlemm@uke.de
• Study Contact Backup: Name: Thies Ingwersen; Phone Number: +49 152 228 34568; Email: thi.ingwersen@uke.de

Study Locations

• Germany
  • Free and Hanseatic City of Hamburg
    • Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
      • Recruiting
      • University Medical Center Hamburg-Eppendorf
      • Contact: Eckhard Schlemm; Phone Number: 0049 152 229 98447; Email: e.schlemm@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the Stroke Unit at the Department of Neurology at University Medical Center Hamburg-Eppendorf

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autonomic dysfunction	Cardiovagal and Adrenergic Scores on the Composite Autonomic Scoring Scale (0-7, higher values indicate greater dysfunction)	3-5 days after stroke onset

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autonomic dysfunction	Cardiovagal and Adrenergic Scores on the Composite Autonomic Scoring Scale (0-7, higher values indicate greater dysfunction)	90 days after stroke onset

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 14, 2024
• First Submitted That Met QC Criteria: December 14, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: acute ischemic stroke; diffusion tensor imaging; transient ischemic attack; Autonomic dysfunction; functional brain network; stroke-heart syndrome; resting-state fMRI; cardiovascular dysregulation; brain-heart axis; autonomic function test; central autonomic network; network lesion mapping; lesion symptom mapping; structural brain network
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Autonomic Nervous System Diseases; Stroke; Ischemic Stroke; Ischemic Attack, Transient; Primary Dysautonomias
• Other Study ID Numbers: 118914145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD used in the results publication will be shared.
• IPD Sharing Time Frame: IPD and supporting information will be made available with the results publication, and will remain accessible for a minimum of ten years.
• IPD Sharing Access Criteria: IPD and supporting information will be publically accessible.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No