Comparison of non-invasive ultrasound diagnostics versus transesophageal echocardiography for the evaluation of proximal sources of embolism in the work-up of juvenile stroke or TIA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017315

Enrollment

300

Registered

2021-06-07

Start date

2019-08-30

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I63 G45

Interventions

Group 1: Transcranial bubble test Extracranial ultrasound of common/internal/external carotid artery with measurement of plaques and intima media thickness (IMT) Differential blood count and hematolog

Eligibility

Sex/Gender

All

Age

No minimum to 60 Years

Inclusion criteria

Inclusion criteria: * Stroke with embolic pattern in brain imaging or TIA with one of the following symptoms: aphasia, apraxia, neglect * Age <= 60 years * Stroke etiology is unclear after routine diagnostics (imaging of extra/intracranial arteries, transthoracic echo, 24-72 hours ECG, antiphospholipid antibodies) * Signed informed consent

Exclusion criteria

Exclusion criteria: * Atrial fibrillation of flutter * Dissection of an artery supplying stroke territory (vertebral or carotid artery) * Stenosis of an artery supplying the stroke territory: ** >= 50% stenosis of internal carotid artery ** >= moderate stenosis of vertebral artery ** >= moderate stenosis of intracranial artery * Vasculitis with CNS involvement * Suspicion of endocarditis * Severe white matter disease and lacunar infarction * TEE not feasible * Refusal for study participation

Design outcomes

Primary

Measure	Time frame
* Accuracy (sensitivity and specificity) of intima media thickness of common carotid artery + negative transcranial bubble test for the exclusion of therapy-relevant proximal embolic sources * Establishment of bubble test, intima media thickness and absence of internal carotid artery plaques as sufficient screening for cardiac/aortic embolic sources in stroke/TIA patients <= 60 years to make TEE dispensable	—

Measure

Time frame

* Accuracy (sensitivity and specificity) of intima media thickness of common carotid artery + negative transcranial bubble test for the exclusion of therapy-relevant proximal embolic sources * Establishment of bubble test, intima media thickness and absence of internal carotid artery plaques as sufficient screening for cardiac/aortic embolic sources in stroke/TIA patients <= 60 years to make TEE dispensable

—

Secondary

Measure	Time frame
* Comparison of patients with and without PFO in TEE and bubble test * Negative and positive predictive value of normal/thickened IMT and/or absence/presence of carotid plaques for the exclusion/presence of complex aortic plaques (<= 4mm thickness, ulcerated or with superimposed thrombi) * Evaluation of the prevalence of clonal hematopoiesis of indeterminate potential (CHIP) and their correlation with stroke etiology and the individual severity of atherosclerosis	—

Measure

Time frame

* Comparison of patients with and without PFO in TEE and bubble test * Negative and positive predictive value of normal/thickened IMT and/or absence/presence of carotid plaques for the exclusion/presence of complex aortic plaques (<= 4mm thickness, ulcerated or with superimposed thrombi) * Evaluation of the prevalence of clonal hematopoiesis of indeterminate potential (CHIP) and their correlation with stroke etiology and the individual severity of atherosclerosis

—

Countries

Germany

Contacts

Public ContactErnst Mayerhofer

Universitätsklinikum FreiburgKlinik für Neurologie und Neurophysiologie

ernst.mayerhofer@uniklinik-freiburg.de+49 270 50010

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026