Skip to main content
OpenTrials
Completed

NCT Number: NCT04726839

Biomarkers algOrithm for strOke diagnoSis and Treatment Resistance Prediction

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department Neurology Caen Hospital, Caen, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • Patient under guardianship or curatorship

Treatment and study plan

Standard of care for stroke management and evaluation of functionnal outcome at 3 months

Other

Additional tubes at inclusion (maximum 13 mL) Collection of the mRS data during a routine visit if planned at 3 months +/-15 days or, if not during a specific research phone call at 3 months

Primary outcomes

  1. Diagnosis by the selected panel of blood biomarkers of the LVO presence eligible for MT

    Time frame: within 24 hours following inclusion

Secondary outcomes

  1. Discrimination by the selected panel of blood biomarkers of LVO from small strokes, and AIS from hemorrhagic strokes and stroke mimics

    Time frame: within 24 hours following inclusion

  2. reperfusion therapy resistance (i.e. IV thrombolysis, MT)

    Time frame: within 24 hours following inclusion

  3. cardio-embolic origin

    Time frame: at 3 months

  4. Early neurological improvement

    Time frame: at day 1 after inclusion

    Early neurological improvement will be assessed by NIHSS. Early neurological improvement will be defined as decrease of 8 points in the NIHSS or a NIHSS 0-1 within 24h for LVO confirmed patients

  5. Functional outcome

    Time frame: at day 90 after inclusion

    Functional outcome will be assessed by modified Rankin Scale (mRS); It consists of a single item, with 6 levels of disability. 0 corresponding to no disability, and five to severe disability.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: BOOST

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2021
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.