Stroke IschemicNCT05906420
Posterior Circulation ASTRAL Prognostic Score
An observational study of Stroke Ischemic and Stroke Acute, run by University of Thessaly at 2 sites in 2 countries.
Trial summary
The goal of this study is to develop a prognostic score for ischemic posterior circulation strokes, based on our previous work on with the ASTRAL scores (Acute STroke Registry and Analysis of Lausanne) on overall stroke prognosis, intracranial occlusion, recanalization and stroke recurrences. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke Ischemic, Stroke Acute, Posterior Circulation Brain Infarction
- What is being tested?
- ASTRAL prognostic score
- How many people
- 2,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2003to 24 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The participants included in this study are exclusively patients with acute ischemic stroke of the posterior circulation arriving at the hospital within 24h since last proof of good health. These patients must have a modified Rankin Score <3 prior the event and available data concerning: age, NIHSS, glucose levels at admission, mRS prior to event and 3 months after the event and acute phase imaging characteristics (CT and/or MRI) including large vessel occlusion, leukoaraiosis and ASPECTS score from the acute CT scan.
Who may be able to join
- Isolated posterior circulation strokes based on clinical or/and imaging evidence.
- Arriving within 24h at hospital since last proof of good health.
Who cannot join
- no available data for 3 months modified Rankin Score
- modified Rankin Score≥3 prior the event
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Greece1 site
First Propedeutic Department of Internal Medicine & Stroke Unit, AHEPA University Hospital, Aristotle University of Thessaloniki
Thessaloniki, Central Macedonia, 54636
Switzerland1 site
Stroke Center, Department of clinical neurosciences, Lausanne University Hospital and University of Lausanne
Lausanne, Vaud Canton, 1011
About this study
Official title: Pc-ASTRAL Score for the Prediction of 3 Months Functional Outcome in Acute Ischemic Stroke at the Posterior Circulation
The goal of this study is to develop a prognostic score for ischemic posterior circulation strokes, based on our previous work on with the ASTRAL scores (Acute STroke Registry and Analysis of Lausanne) on overall stroke prognosis, intracranial occlusion, recanalization and stroke recurrences. The main question it aims to answer is the modified Rankin score in 3 months after the event.
Participants will be patients with acute ischemic stroke of the posterior circulation with mRS priot to event <3. All the data will be collected retrospectively from patients included in the ASTRAL registry between January 2003 and December 2021. The ASTRAL registry will be used as the derivation cohort of the score. Demographics, acute glucose, NIHSS score and acute imaging of each participant will be used from the derivation cohort in order to create an integer-based prognostic score. After internal validation, we plan to validate the score in external stroke registries to show its validity.
- Being tested
- ASTRAL prognostic score
- Medical subject headings
- Ischemic Stroke, Stroke, Brain Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASTRAL prognostic scoreDiagnostic test
ASTRAL prognostic score
| Study group | Role | What they receive |
|---|---|---|
| ASTRAL | Not described Receives: Diagnostic Test: ASTRAL prognostic score | |
| Basel cohort | Not described Receives: Diagnostic Test: ASTRAL prognostic score | |
| Berlin cohort | Not described Receives: Diagnostic Test: ASTRAL prognostic score | |
| Bern Cohort | Not described Receives: Diagnostic Test: ASTRAL prognostic score | |
| Bologna cohort | Not described Receives: Diagnostic Test: ASTRAL prognostic score | |
| Dijon cohort | Not described Receives: Diagnostic Test: ASTRAL prognostic score | |
| Lisbon cohort | Not described Receives: Diagnostic Test: ASTRAL prognostic score | |
| Israel cohort | Not described Receives: Diagnostic Test: ASTRAL prognostic score | |
| Innsbruck cohort | Not described Receives: Diagnostic Test: ASTRAL prognostic score | |
| St. Gallen cohort | Not described Receives: Diagnostic Test: ASTRAL prognostic score | |
| Lugano cohort | Not described Receives: Diagnostic Test: ASTRAL prognostic score | |
| Chicago cohort | Not described Receives: Diagnostic Test: ASTRAL prognostic score | |
| West Virginia cohort | Not described Receives: Diagnostic Test: ASTRAL prognostic score | |
| Zurich cohort | Not described Receives: Diagnostic Test: ASTRAL prognostic score | |
| Seoul cohort | Not described Receives: Diagnostic Test: ASTRAL prognostic score |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 months modified Ranking scale
evaluation of 3 months neurological disability
Measured: January 2003-December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jan 2003
- Primary completion31 Dec 2021
- Study completion24 Nov 2025 (estimated)
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.
- 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne, Centre Hospitalier Universitaire Vaudois
- Responsible party
- Principal investigator, George Ntaios, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906420
- Sponsor's protocol ID
- pc-ASTRAL
- Status last verified
- Apr 2025
- First submitted
- 6 Jun 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pc-ASTRAL Score for the Prediction of 3 Months Functional Outcome in Acute Ischemic Stroke at the Posterior Circulation
- ClinicalTrials.gov ID
- NCT05906420
- Acronym / sponsor ID
- pc-ASTRAL
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Collaborators
- University of Lausanne, Centre Hospitalier Universitaire Vaudois
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 24 Nov 2025 (estimated)
- First posted
- 15 Jun 2023 (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.
The goal of this study is to develop a prognostic score for ischemic posterior circulation strokes, based on our previous work on with the ASTRAL scores (Acute STroke Registry and Analysis of Lausanne) on overall stroke prognosis, intracranial occlusion, recanalization and stroke recurrences. The main question it aims to answer is the modified Rankin score in 3 months after the event.
Participants will be patients with acute ischemic stroke of the posterior circulation with mRS priot to event <3. All the data will be collected retrospectively from patients included in the ASTRAL registry between January 2003 and December 2021. The ASTRAL registry will be used as the derivation cohort of the score. Demographics, acute glucose, NIHSS score and acute imaging of each participant will be used from the derivation cohort in order to create an integer-based prognostic score. After internal validation, we plan to validate the score in external stroke registries to show its validity.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| ASTRAL | – | Diagnostic Test: ASTRAL prognostic score |
| Basel cohort | – | Diagnostic Test: ASTRAL prognostic score |
| Berlin cohort | – | Diagnostic Test: ASTRAL prognostic score |
| Bern Cohort | – | Diagnostic Test: ASTRAL prognostic score |
| Bologna cohort | – | Diagnostic Test: ASTRAL prognostic score |
| Dijon cohort | – | Diagnostic Test: ASTRAL prognostic score |
| Lisbon cohort | – | Diagnostic Test: ASTRAL prognostic score |
| Israel cohort | – | Diagnostic Test: ASTRAL prognostic score |
| Innsbruck cohort | – | Diagnostic Test: ASTRAL prognostic score |
| St. Gallen cohort | – | Diagnostic Test: ASTRAL prognostic score |
| Lugano cohort | – | Diagnostic Test: ASTRAL prognostic score |
| Chicago cohort | – | Diagnostic Test: ASTRAL prognostic score |
| West Virginia cohort | – | Diagnostic Test: ASTRAL prognostic score |
| Zurich cohort | – | Diagnostic Test: ASTRAL prognostic score |
| Seoul cohort | – | Diagnostic Test: ASTRAL prognostic score |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The participants included in this study are exclusively patients with acute ischemic stroke of the posterior circulation arriving at the hospital within 24h since last proof of good health. These patients must have a modified Rankin Score <3 prior the event and available data concerning: age, NIHSS, glucose levels at admission, mRS prior to event and 3 months after the event and acute phase imaging characteristics (CT and/or MRI) including large vessel occlusion, leukoaraiosis and ASPECTS score from the acute CT scan.
Key inclusion criteria (2 listed)
- Isolated posterior circulation strokes based on clinical or/and imaging evidence.
- Arriving within 24h at hospital since last proof of good health.
Key exclusion criteria (2 listed)
- no available data for 3 months modified Rankin Score
- modified Rankin Score≥3 prior the event
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 |
|---|---|---|
| ASTRAL prognostic scoreASTRAL prognostic score | Diagnostic test | ASTRAL, Basel cohort, Berlin cohort, Bern Cohort, Bologna cohort, Chicago cohort, Dijon cohort, Innsbruck cohort, Israel cohort, Lisbon cohort, Lugano cohort, Seoul cohort, St. Gallen cohort, West Virginia cohort, Zurich cohort |
Primary outcome
3 months modified Ranking scale
Time frame: January 2003-December 2021
evaluation of 3 months neurological disability
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Ischemic and Stroke Acute, run by University of Thessaly at 2 sites in 2 countries.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece, Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
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?
3 months modified Ranking scale (time frame: January 2003-December 2021). 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 8 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.