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RecruitingNCT06740942ARIADNEUpdated May 7, 2026

Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke

An observational study in Acute Ischemic Stroke and Transient Ischemic Attack, sponsored by Universitätsklinikum Hamburg-Eppendorf. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • 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
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 100 is below the median of 300 across 771 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
    • 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
  • by either the patient or a legal representative (including a spouse)

Exclusion criteria

Exclusion Criteria:

  • In-hospital stroke,
  • 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 \< 50%,
  • concomitant systemic illness that can lead to dysautonomia, such as an active infection, thyroid disease, or neurodegenerative disorder (e.g. PD, MSA).
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Autonomic dysfunction

    Cardiovagal and Adrenergic Scores on the Composite Autonomic Scoring Scale (0-7, higher values indicate greater dysfunction)

    Time frame: 3-5 days after stroke onset

Secondary outcomes

  1. Autonomic dysfunction

    Cardiovagal and Adrenergic Scores on the Composite Autonomic Scoring Scale (0-7, higher values indicate greater dysfunction)

    Time frame: 90 days after stroke onset

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All IPD used in the results publication will be shared.

Supporting information: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Sep 2026, 13 months after the start.

Of 394 non-industry observational studies under Ischemic Stroke, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 140. This study's planned 13 months is below that.

Counting every sponsor, half of 436 studies reached it within 53 months; a quarter within 24 and three quarters within 127.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 14, 2024
First posted
Dec 18, 2024
StartActual
Aug 4, 2025
Primary completionEst.
Sep 2026
CompletionEst.
Dec 2026
Last update
May 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06740942
Responsible party
Eckhard Schlemm (Principal Investigator, Universitätsklinikum Hamburg-Eppendorf) — Principal investigator
First posted
Dec 18, 2024
Start date
Aug 4, 2025
Primary completion
Sep 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 7, 2026

Study contacts

Eckhard Schlemm
Contact
e.schlemm@uke.de
+49 152 228 98447
Thies Ingwersen
Contact
thi.ingwersen@uke.de
+49 152 228 34568

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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