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NCT04726839Completed

Biomarkers algOrithm for strOke diagnoSis and Treatment Resistance Prediction

Source: ClinicalTrials.gov · Last updated 16 Sept 2025

Brief summary (registry, in English)

Triage of acute ischemic stroke (AIS) patients is critical, to decrease time to treatment, and improve functional outcome. The therapeutic standard of care for AIS consecutive to large vessel occlusion (LVO) is the association of intravenous (IV) alteplase administration and mechanical thrombectomy (MT). However, there are limited places where MT can be performed. Therefore, there is a need for innovative tools to identify, in the ambulance, patients with LVO that require MT. Sending the patients at the right, avoiding futile stops (i.e. in places where MT is not available), is definitively a strategy that saves time. There is currently no biomarker nor Point Of Care (POC) Lab Testing to solve this issue and clinical scoring methods such as the NIHSS have a low accuracy rate to detect LVO. The relevance of blood biomarkers for LVO diagnosis and therapeutic decisions needs to be confirmed for effective triage in the setting of AIS with LVO, which represent 30% of all AIS. The main objective of our study is to determine diagnostic performances of a panel of selected blood biomarkers to identify patients with AIS consecutive to LVO among those with stroke suspicion, within 24 hours of stroke symptom's onset before brain imaging. This could facilitate the triage of patients with LVO refractory to thrombolysis treatment, who may benefit most from MT.

Status (registry)
Completed
Study type
Observational
Enrollment
3880 (actual)
First submitted
24 Jan 2021
Start date
Mar 2021
Primary completion date
Jul 2025
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Diseases
Stroke
NCT number
NCT04726839

What you commit to

  • Study type: Observational
  • Participants enrolled: 3880
  • From Mar 2021 to the primary completion date, Jul 2025
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Patient under guardianship or curatorship

Who the study is looking for

  • Symptoms consistent with stroke \<24 hours
  • Adult patients ≥ 18 years old
  • Non opposition of the patient or his/her relatives to the research (emergency inclusion procedure)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department Neurology Caen Hospital
Coordinator of this site? Confirm its status
CaenFranceUnknown status
Rothschild Foundation Hospital
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Lariboisière
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Hospital Foch
Coordinator of this site? Confirm its status
SuresnesFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.