Acute StrokeBP-METROLOGYNCT03359434
Blood Pressure Measurement Methods and Prediction of Intracranial Hemorrhage After Thrombectomy in Stroke
An observational study of Acute Stroke and Blood Pressure, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
A monocentric, non-randomized, prospective study in which each patient is his/her own control. The study investigates 2 methods of blood pressure measurement, within the first 24 hours after reperfusion, i) Continuous measurement of blood pressure with the Clearsight device (Edwards) and ii) intermittent blood… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke, Blood Pressure, Cerebral Hemorrhage
- What is being tested?
- Clearsight device (Edwards) around the finger and Intermittent blood pressure measurements with cuff.
- Type of treatment
- Medical device
- How many people
- 455 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2018to 4 Dec 2024
- How long will I take part?
- 3 Days
- 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 thrombectomy after acute stroke
Who may be able to join
- Patient aged 18 years or older
- Treated for occlusion of the internal carotid arteries and/or proximal middle cerebral arteries (M1 and M2 segments), vertebral artery, and/or basilar artery
- Affiliated with or beneficiary of a Social Security plan
- Having received informed information about the study and having given consent to participate in the study
Who cannot join
- Per-procedure hemorrhagic complications (before reperfusion is achieved)
- Patient benefiting from legal protection measures
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Blood Pressure Measurement Methods for the Prediction of Intracranial Hemorrhage After Thrombectomy in Acute Stroke
A monocentric, non-randomized, prospective study in which each patient is his/her own control.
The study investigates 2 methods of blood pressure measurement, within the first 24 hours after reperfusion, i) Continuous measurement of blood pressure with the Clearsight device (Edwards) and ii) intermittent blood pressure measurements with cuff.
Read the detailed description
Patients will be followed for 72 hours:
- inclusion after reperfusion: clinical evaluation with NIHSS (National Institute of Health Stroke Score) score, measurement of blood pressure.
- within 24 hours after reperfusion: blood pressure measurements
- at 24 hours: NIHSS score.
- Between 24 and 36 hours :cerebral scan (assessment of hemorrhagic transformations and cerebral infarction volumes).
- 72 hours after reperfusion: brain scanner in case of hyperdensity on the initial scanner
- Conditions
- Acute Stroke, Blood Pressure, Cerebral Hemorrhage
- Being tested
- Clearsight device (Edwards) around the finger, Intermittent blood pressure measurements with cuff.
- Keywords
- Acute Stroke, Blood Pressure, Cerebral Hemorrhage
- Medical subject headings
- Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clearsight device (Edwards) around the fingerDevice
Continuous measurement of blood pressure with the Clearsight device (Edwards) around the finger, within 24 hours after reperfusion:
Intermittent blood pressure measurements with cuff.Device
Standard method: 35 blood pressure measurements with cuff within 24 hours after reperfusion
| Study group | Role | What they receive |
|---|---|---|
| Two measuring methods of blood pressure | Not described Receives: Device: Clearsight device (Edwards) around the finger; Device: Intermittent blood pressure measurements with cuff. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of intracranial hemorrhagic complications
number of intracranial hemorrhagic complications (symptomatic or asymptomatic) on brain scanner, evaluated with a double centralized blind reading
Measured: 36 hours after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start5 Dec 2018
- Primary completion17 Dec 2023
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- 455 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- MAZIGHI Mikael, MD PhD, Principal investigator, Fondation Ophtalmologique A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359434
- Sponsor's protocol ID
- MMI_2017_12
- Acronym
- BP-METROLOGY
- Status last verified
- Apr 2026
- First submitted
- 27 Nov 2017
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Matthys A, Bedoucha L, Di Meglio F, Sabben C, Obadia M, Le Cossec C, Labreuche J, Boursin P, Mazighi M, Di Meglio L. BP-METROLOGY: non-invasive continuous blood pressure monitoring to predict haemorrhagic transformation after endovascular thrombectomy. Eur Stroke J. 2026 Mar 1;11(3):aakag012. doi: 10.1093/esj/aakag012.
PubMed 41871383
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Blood Pressure Measurement Methods for the Prediction of Intracranial Hemorrhage After Thrombectomy in Acute Stroke
- ClinicalTrials.gov ID
- NCT03359434
- Acronym / sponsor ID
- BP-METROLOGY / MMI_2017_12
- Conditions
- Acute Stroke, Blood Pressure, Cerebral Hemorrhage
- Keywords
- Acute Stroke, Blood Pressure, Cerebral Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 17 Dec 2023 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 2 Dec 2017 (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.
A monocentric, non-randomized, prospective study in which each patient is his/her own control.
The study investigates 2 methods of blood pressure measurement, within the first 24 hours after reperfusion, i) Continuous measurement of blood pressure with the Clearsight device (Edwards) and ii) intermittent blood pressure measurements with cuff.
Detailed description
Patients will be followed for 72 hours:
- inclusion after reperfusion: clinical evaluation with NIHSS (National Institute of Health Stroke Score) score, measurement of blood pressure.
- within 24 hours after reperfusion: blood pressure measurements
- at 24 hours: NIHSS score.
- Between 24 and 36 hours :cerebral scan (assessment of hemorrhagic transformations and cerebral infarction volumes).
- 72 hours after reperfusion: brain scanner in case of hyperdensity on the initial scanner
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Two measuring methods of blood pressure | – | Device: Clearsight device (Edwards) around the finger, Device: Intermittent blood pressure measurements with cuff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with thrombectomy after acute stroke
Key inclusion criteria (4 listed)
- Patient aged 18 years or older
- Treated for occlusion of the internal carotid arteries and/or proximal middle cerebral arteries (M1 and M2 segments), vertebral artery, and/or basilar artery
- Affiliated with or beneficiary of a Social Security plan
- Having received informed information about the study and having given consent to participate in the study
Key exclusion criteria (3 listed)
- Per-procedure hemorrhagic complications (before reperfusion is achieved)
- Patient benefiting from legal protection measures
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Clearsight device (Edwards) around the fingerContinuous measurement of blood pressure with the Clearsight device (Edwards) around the finger, within 24 hours after reperfusion: | Device | Two measuring methods of blood pressure |
| Intermittent blood pressure measurements with cuff.Standard method: 35 blood pressure measurements with cuff within 24 hours after reperfusion | Device | Two measuring methods of blood pressure |
Primary outcome
Occurence of intracranial hemorrhagic complications
Time frame: 36 hours after baseline
number of intracranial hemorrhagic complications (symptomatic or asymptomatic) on brain scanner, evaluated with a double centralized blind reading
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 9 Apr 2026.
- Results publication: PubMed 41871383Matthys A, Bedoucha L, Di Meglio F, Sabben C, Obadia M, Le Cossec C, Labreuche J, Boursin P, Mazighi M, Di Meglio L. BP-METROLOGY: non-invasive continuous blood pressure monitoring to predict haemorrhagic transformation after endovascular thrombectomy. Eur Stroke J. 2026 Mar 1;11(3):aakag012. doi: 10.1093/esj/aakag012.
- 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.
MAZIGHI Mikael, MD PhD principal investigator
Fondation Ophtalmologique A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke and Blood Pressure, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site 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 4 inclusion and 3 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 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Occurence of intracranial hemorrhagic complications (time frame: 36 hours after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03359434, which also lists 1 linked publication.
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 9 Apr 2026.