Acute Ischemic StrokeARIADNENCT06740942
Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke
An observational study of Acute Ischemic Stroke and Transient Ischemic Attack, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Transient Ischemic Attack
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 4 Aug 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the Stroke Unit at the Department of Neurology at University Medical Center Hamburg-Eppendorf
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
Eckhard Schlemm, 0049 152 229 98447, e.schlemm@uke.de
About this study
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.
Read more
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
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient, Primary Dysautonomias
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic dysfunction
Cardiovagal and Adrenergic Scores on the Composite Autonomic Scoring Scale (0-7, higher values indicate greater dysfunction)
Measured: 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)
Measured: 90 days after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start4 Aug 2025
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eckhard Schlemm, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740942
- Sponsor's protocol ID
- 118914145
- Acronym
- ARIADNE
- Status last verified
- May 2026
- First submitted
- 14 Dec 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD used in the results publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06740942
- Acronym / sponsor ID
- ARIADNE / 118914145
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the Stroke Unit at the Department of Neurology at University Medical Center Hamburg-Eppendorf
Key inclusion criteria (7 listed)
- Diagnosis of either
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Autonomic dysfunction
Time frame: 3-5 days after stroke onset
Cardiovagal and Adrenergic Scores on the Composite Autonomic Scoring Scale (0-7, higher values indicate greater dysfunction)
1 secondary outcome
Autonomic dysfunction
Time frame: 90 days after stroke onset
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Yes. All IPD used in the results publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke and Transient Ischemic Attack, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eckhard Schlemm (+49 152 228 98447, e.schlemm@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomic dysfunction (time frame: 3-5 days after stroke onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.