Imaging and Serological Biomarkers of Autonomic Dysfuncti... | NCT06740942

Studies
Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke

NCT06740942

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Status

Recruiting

Last Update Posted

May 7, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Acute Ischemic Stroke
Transient Ischemic Attack

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 4, 2025Actual

Primary Completion Date

Sep 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Dec 14, 2024

First Submission Date that Met QC Criteria

Dec 14, 2024

First Posted Date

Dec 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2026

Last Update Posted Date

May 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients will be recruited from the Stroke Unit at the Department of Neurology at University Medical Center Hamburg-Eppendorf

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eckhard Schlemm	Contact	+49 152 228 98447		e.schlemm@uke.de
Thies Ingwersen	Contact	+49 152 228 34568		thi.ingwersen@uke.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Hamburg-Eppendorf	Recruiting	Hamburg	Free and Hanseatic City of Hamburg	20246	Germany

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All IPD used in the results publication will be shared.

Types

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.

URL

Not provided

ID	Term
D000083242	Ischemic Stroke
D002546	Ischemic Attack, Transient
D054969	Primary Dysautonomias

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases