Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke

NCT06740942 | Recruiting

• 1 other identifier: 118914145
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Autonomic dysfunction

  90 days after stroke onset

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

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

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Autonomic Nervous System Diseases

Central Study Contacts

Eckhard Schlemm

CONTACT

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

Thies Ingwersen

CONTACT

+49 152 228 34568; thi.ingwersen@uke.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 18, 2024
• Study Start: August 4, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: IPD and supporting information will be made available with the results publication, and will remain accessible for a minimum of ten years.
• Access Criteria: IPD and supporting information will be publically accessible.

Locations

DE (1)