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

• Conditions: I63; G45; Cerebral infarction; Transient cerebral ischaemic attacks and related syndromes

• Registration Number: DRKS00017315
• Lead Sponsor: niversitätsklinikum FreiburgKlinik für Neurologie und Neurophysiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-04-30
• Study Start: 2021-06-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 279

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

* 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
* 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<br>* 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 Outcome Measures

Name	Time	Method
* Comparison of patients with and without PFO in TEE and bubble test <br>* 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)<br>* Evaluation of the prevalence of clonal hematopoiesis of indeterminate potential (CHIP) and their correlation with stroke etiology and the individual severity of atherosclerosis