NCT06319742: ElViS-ACS

Extracellular Vesicle Surface Markers In Acute Cerebrovascular Syndromes.

Recruiting now Last updated 18 April 2024

What this trial tests

trial testing Extracellular vescicles (EV) analysis in Stroke, TIA, Stroke-mimics, Stroke Biomarkers in 200 participants. Currently enrolling.

Timeline

18 November 2022

Primary endpoint
31 December 2025

31 January 2026

Quick facts

Lead sponsor	Ospedale Civico, Lugano
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	200
Start date	18 November 2022
Primary completion	31 December 2025
Estimated completion	31 January 2026
Sites	1 location across Switzerland

Drugs / interventions tested

• Extracellular vescicles (EV) analysis

Conditions studied

• Stroke, TIA, Stroke-mimics, Stroke Biomarkers — all drugs for Stroke, TIA, Stroke-mimics, Stroke Biomarkers →

Sponsor

Ospedale Civico, Lugano

Who can join

18 and older, any sex, with Stroke, TIA, Stroke-mimics, Stroke Biomarkers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Clinical implication of eventual blood biomarkers for stroke diagnosis and prognosis would be limited, mainly because clinical evaluation and scales (providing stroke severity) or neuroimaging (providing accurate size of the lesion) are more reliable predictors for clinical outcome prediction. In clinical practice, it would be more useful to find a biomarker, which can help to orientate the physician in conditions in which the clinical picture and imaging provide a limited support.

Transient Ischemic Attacks (TIAs) represent a classical example for which a biomarker would be of interest to confirm and distinguish a brain ischemic process from a stroke mimic. Diagnostic biomarkers of TIA have been investigated, but none of the potential candidates reached enough accuracy for TIA diagnosis. Our group has found that Extracellular Vesicles (EVs) could be useful as biomarkers for detecting brain ischemia in patients with TIA because the EV-surface antigen profile appears to be different in patients with transient symptoms, adjudicated to be very likely caused by brain ischemia, compared to patients whose symptoms were less likely to due to brain ischemia. Our study has raised interest in the scientific community recognizing the promising role of of blood-derived EVs analysis in expanding the possibilities to correctly diagnose and classify TIA and stroke events, discriminate them from TIA or stroke mimics, with important future implications in management and therapy of the patients with acute ischemic cerebrovascular syndrome. the validity of our approach needs to be tested in a larger, prospective, multicenter study.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging Role of Extracellular Vesicles as Biomarkers in Neurodegenerative Diseases and Their Clinical and Therapeutic Potential in Central Nervous System Pathologies.
   Malaguarnera M, Cabrera-Pastor A. · · 2024 · cited 30× · PMID 39337560 · DOI 10.3390/ijms251810068
2. Exosomes in Central Nervous System Diseases: A Comprehensive Review of Emerging Research and Clinical Frontiers.
   Li J, Song J, Jia L, Wang M, et al · · 2024 · cited 11× · PMID 39766226 · DOI 10.3390/biom14121519
3. Harnessing the Potential of Exosomes in Therapeutic Interventions for Brain Disorders.
   Bai L, Yu L, Ran M, Zhong X, et al · · 2025 · cited 8× · PMID 40141135 · DOI 10.3390/ijms26062491
4. Emerging Targeted Delivery Strategies of Nanosystems for Ischemic Stroke Treatment.
   Ren JX, Ma HY, Yin WJ, Li YK, et al · · 2025 · cited 4× · PMID 40584781 · DOI 10.2147/ijn.s519328
5. Exosomes in stroke management: A promising paradigm shift in stroke therapy.
   Wang B, Chen P, Li W, Chen Z. · · 2026 · cited 2× · PMID 39665811 · DOI 10.4103/nrr.nrr-d-24-00665
6. Clinical Applications of Extracellular Vesicles: Promises and Pitfalls.
   Primorac D, Brlek P, Bulić L, Hrvatin N, et al · · 2026 · cited 1× · PMID 41683929 · DOI 10.3390/ijms27031509
7. Extracellular vesicles: Revolutionizing targeted therapy for ischemic stroke.
   Bai J, Yang J, Liu W, Han B, et al · · 2026 · PMID 42180524 · DOI 10.1016/j.apsb.2026.03.025
8. Harnessing extracellular vesicles for ischemic stroke management.
   Haroon K, Yu J, Li R, Ren C, et al · · 2026 · PMID 41994598 · DOI 10.1093/rb/rbag038