NCT05906420

Brief 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. 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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
19 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2025

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

19 years

First QC Date

June 6, 2023

Last Update Submit

April 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 3 months modified Ranking scale

    evaluation of 3 months neurological disability

    January 2003-December 2021

Study Arms (15)

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

Interventions

ASTRAL prognostic score

ASTRALBasel cohortBerlin cohortBern CohortBologna cohortChicago cohortDijon cohortInnsbruck cohortIsrael cohortLisbon cohortLugano cohortSeoul cohortSt. Gallen cohortWest Virginia cohortZurich cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Isolated posterior circulation strokes based on clinical or/and imaging evidence.
  • Arriving within 24h at hospital since last proof of good health.

You may not qualify if:

  • no available data for 3 months modified Rankin Score
  • modified Rankin Score≥3 prior the event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

First Propedeutic Department of Internal Medicine & Stroke Unit, AHEPA University Hospital, Aristotle University of Thessaloniki

Thessaloniki, Central Macedonia, 54636, Greece

Location

Stroke Center, Department of clinical neurosciences, Lausanne University Hospital and University of Lausanne

Lausanne, Vaud Canton, 1011, Switzerland

Location

MeSH Terms

Conditions

Ischemic StrokeStrokeBrain Infarction

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain IschemiaInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine George Ntaios

Study Record Dates

First Submitted

June 6, 2023

First Posted

June 15, 2023

Study Start

January 1, 2003

Primary Completion

December 31, 2021

Study Completion

November 24, 2025

Last Updated

April 8, 2025

Record last verified: 2025-04

Locations