Clinical trial NCT06740942: Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke
Official title: Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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).

Primary outcomes:
measure: Autonomic dysfunction
timeFrame: 3-5 days after stroke onset
Secondary outcomes:
measure: Autonomic dysfunction
timeFrame: 90 days after stroke onset
Other outcomes:
Locations:
Study officials:
References: