Stroke, IschemicBOOSTNCT04726839
Biomarkers algOrithm for strOke diagnoSis and Treatment Resistance Prediction
An observational study of Stroke, Ischemic and Large Vessel Occlusion, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Large Vessel Occlusion
- How many people
- 3,880 participants
- Where
- 4 sitesFrance
- Study dates
- 12 Mar 2021to 10 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stroke suspicion within 24 hours of stroke's symptoms
Who may be able to join
- 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)
Who cannot join
- Patient under guardianship or curatorship
Trial locations and contacts
4 sites in 1 country.
France4 sites
Department Neurology Caen Hospital
Caen
Lariboisière
Paris, 75010
Rothschild Foundation Hospital
Paris
Hospital Foch
Suresnes
About this study
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.
Read more
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.
- Conditions
- Stroke, Ischemic, Large Vessel Occlusion
- Being tested
- Standard of care for stroke management and evaluation of functionnal outcome at 3 months
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care for stroke management and evaluation of functionnal outcome at 3 monthsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Stroke suspicion | Patients with stroke suspicion within 24 hours of stroke's symptoms Receives: Other: Standard of care for stroke management and evaluation of functionnal outcome at 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis by the selected panel of blood biomarkers of the LVO presence eligible for MT
Measured: within 24 hours following inclusion
Secondary outcomes (5)
Discrimination by the selected panel of blood biomarkers of LVO from small strokes, and AIS from hemorrhagic strokes and stroke mimics
Measured: within 24 hours following inclusion
reperfusion therapy resistance (i.e. IV thrombolysis, MT)
Measured: within 24 hours following inclusion
cardio-embolic origin
Measured: at 3 months
Early neurological improvement
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
Measured: at day 1 after inclusion
Functional outcome
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.
Measured: at day 90 after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start12 Mar 2021
- Primary completion10 Jul 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,880 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726839
- Sponsor's protocol ID
- APHP200188
- Acronym
- BOOST
- Status last verified
- Sep 2025
- First submitted
- 24 Jan 2021
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers algOrithm for strOke diagnoSis and Treatment Resistance Prediction
- ClinicalTrials.gov ID
- NCT04726839
- Acronym / sponsor ID
- BOOST / APHP200188
- Conditions
- Stroke, Ischemic, Large Vessel Occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,880 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke suspicion | – | Other: Standard of care for stroke management and evaluation of functionnal outcome at 3 monthsPatients with stroke suspicion within 24 hours of stroke's symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stroke suspicion within 24 hours of stroke's symptoms
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Patient under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care for stroke management and evaluation of functionnal outcome at 3 monthsAdditional 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 | Other | Stroke suspicion |
Primary outcome
Diagnosis by the selected panel of blood biomarkers of the LVO presence eligible for MT
Time frame: within 24 hours following inclusion
5 secondary outcomes
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
reperfusion therapy resistance (i.e. IV thrombolysis, MT)
Time frame: within 24 hours following inclusion
cardio-embolic origin
Time frame: at 3 months
Early neurological improvement
Time frame: at day 1 after inclusion
Functional outcome
Time frame: at day 90 after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic and Large Vessel Occlusion, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis by the selected panel of blood biomarkers of the LVO presence eligible for MT (time frame: within 24 hours following inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.