Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke

Universitätsklinikum Hamburg-Eppendorf0 sites100 target enrollmentApril 2025

ConditionsAcute Ischemic Stroke Transient Ischemic Attack

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Ischemic Stroke
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Enrollment: 100
Primary Endpoint: Autonomic dysfunction
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2025

End Date

May 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Responsible Party

Principal Investigator

Eckhard Schlemm

Principal Investigator

Universitätsklinikum Hamburg-Eppendorf

Eligibility Criteria

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).