Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke

Not yet recruiting

• Conditions: Acute Ischemic Stroke; Transient Ischemic Attack

• Registration Number: NCT06740942
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-14
• Study First Submitted QC: 2024-12-14
• Study First Posted: 2024-12-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13
• Study Start: 2025-04
• Primary Completion: 2026-02
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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