Ischemic StrokeSTANDNCT04180826
STAND: iSchemic sTroke evAluated at Bed Side With ultrasouND
An observational study of Ischemic Stroke and Carotid Stenosis, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Ischemic strokes account for more than 80% of strokes. Ischemic strokes are caused by the occlusion of an intracranial artery by a thrombus, responsible for tissue ischemia related to a decrease in local cerebral blood flow (CBS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Carotid Stenosis
- What is being tested?
- Observational
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2019to 3 Mar 2021
- 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: Patient with ischemic stroke or transient ischemic attack of less than 48 hours with or without carotid stenosis greater than 50% NASCET or occlusion
Who may be able to join
- Patient over 18 years of age
- acute ischemic stroke or transient ischemic attack
- symptoms onset < 48 hours
- Absence of homolateral or downstream intracranial stenosis or M1 occlusion
- Verticalization authorized by the referent clinician.
- Rankin's score before AIC/AIT ≤ 2
Show all 12Show fewer
- Non-opposition to participation in the study
- Criteria for inclusion of cases
- Carotid stenosis of more than 50% NASCET or an occlusion
- Criteria for including witnesses - Absence of carotid stenosis greater than 50% NASCET or occlusion
- Criteria for non-inclusion
- Disrupted vigilance
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Verticalization on Intracranial Hemodynamics Assessed by Continuous Transcranial Doppler Monitoring at the Acute Phase of Ischemic Stroke
Ischemic strokes account for more than 80% of strokes. Ischemic strokes are caused by the occlusion of an intracranial artery by a thrombus, responsible for tissue ischemia related to a decrease in local cerebral blood flow (CBS). Thus, the management of patients with Ischemic strokes is based on the preservation of an area that maintains sufficient intracranial hemodynamics (IH) and achieves the fastest possible recanalization. The impact of the patient's position (supine or seated position) on the IH in the event of narrowing or occlusion of an artery is poorly assessed but may be of particular importance. In practice, variations in blood flow according to the positioning of the patient's body can be measured using a transcranial Doppler. It is a simple, non-invasive and painless examination that provides the patient's bed with data on the intracerebral hemodynamic profile of patients.
This study was implemented because there are no studies known to us that evaluate the effect of verticalization on intracerebral hemodynamics based on the presence of upstream arterial stenosis or occlusion and other multimodal evaluation data in transcranial Doppler.
- Conditions
- Ischemic Stroke, Carotid Stenosis
- Being tested
- Observational
- Medical subject headings
- Ischemic Stroke, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Initially, the patient will be placed in a strict supine position (at 0°) in his hospital bed, according to the usual care.
In a second step, the patient will be verticalized (from 0° to 90°). Intracranial hemodynamics parameters in supine position and during verticalization will be continuously recorded by attaching the ATYS TCD-X® transcranial Doppler helmet attached with glasses.
After 15 minutes of recording, the patient will be placed back in supine position. The end of the patient's participation in the study will correspond to the removal of the ATYS TCD-X® helmet.
| Study group | Role | What they receive |
|---|---|---|
| Stenosis | Patients with stenosis Receives: Other: Observational | |
| No stenosis | Patients without stenosis Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the monitoring of patient care
drop of more than 10% of the mean velocity between the supine and seated position
Measured: 2 minutes after verticalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start15 Jan 2019
- Primary completion15 Jan 2021
- Study completion3 Mar 2021
Why it stopped: alll patients have been included
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Collaborators
- Hopital Lariboisière
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180826
- Sponsor's protocol ID
- 2018-A03454-51
- Acronym
- STAND
- Status last verified
- Mar 2021
- First submitted
- 26 Nov 2019
- Last updated
- 4 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Verticalization on Intracranial Hemodynamics Assessed by Continuous Transcranial Doppler Monitoring at the Acute Phase of Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04180826
- Acronym / sponsor ID
- STAND / 2018-A03454-51
- Conditions
- Ischemic Stroke, Carotid Stenosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: alll patients have been included
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Collaborators
- Hopital Lariboisière
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 29 Nov 2019 (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.
Ischemic strokes account for more than 80% of strokes. Ischemic strokes are caused by the occlusion of an intracranial artery by a thrombus, responsible for tissue ischemia related to a decrease in local cerebral blood flow (CBS). Thus, the management of patients with Ischemic strokes is based on the preservation of an area that maintains sufficient intracranial hemodynamics (IH) and achieves the fastest possible recanalization. The impact of the patient's position (supine or seated position) on the IH in the event of narrowing or occlusion of an artery is poorly assessed but may be of particular importance. In practice, variations in blood flow according to the positioning of the patient's body can be measured using a transcranial Doppler. It is a simple, non-invasive and painless examination that provides the patient's bed with data on the intracerebral hemodynamic profile of patients.
This study was implemented because there are no studies known to us that evaluate the effect of verticalization on intracerebral hemodynamics based on the presence of upstream arterial stenosis or occlusion and other multimodal evaluation data in transcranial Doppler.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stenosis | – | Other: ObservationalPatients with stenosis |
| No stenosis | – | Other: ObservationalPatients without stenosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with ischemic stroke or transient ischemic attack of less than 48 hours with or without carotid stenosis greater than 50% NASCET or occlusion
Key inclusion criteria (12 listed)
- Patient over 18 years of age
- acute ischemic stroke or transient ischemic attack
- symptoms onset < 48 hours
- Absence of homolateral or downstream intracranial stenosis or M1 occlusion
- Verticalization authorized by the referent clinician.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ObservationalInitially, the patient will be placed in a strict supine position (at 0°) in his hospital bed, according to the usual care. In a second step, the patient will be verticalized (from 0° to 90°). Intracranial hemodynamics parameters in supine position and during verticalization will be continuously recorded by attaching the ATYS TCD-X® transcranial Doppler helmet attached with glasses. After 15 minutes of recording, the patient will be placed back in supine position. The end of the patient's participation in the study will correspond to the removal of the ATYS TCD-X® helmet. | Other | No stenosis, Stenosis |
Primary outcome
Change in the monitoring of patient care
Time frame: 2 minutes after verticalization
drop of more than 10% of the mean velocity between the supine and seated position
Results and safety
The study was stopped early (reason given: alll patients have been included). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Individual participant dataSharing planned: No
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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.
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 Ischemic Stroke and Carotid Stenosis, 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 12 inclusion and 0 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: stopped early, as of the sponsor's last update on 4 Mar 2021. 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 was stopped early (reason given: alll patients have been included). Results are not available in the source record.
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?
Change in the monitoring of patient care (time frame: 2 minutes after verticalization). 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 4 Mar 2021.