Overall Study
Group that receives steroid treatment right away
What is Group A?
The required blood collection timepoints
What is baseline and 1 month post stroke timepoint?
The required imaging timepoints
What is baseline, 5 days post stroke, 1 month post stroke timepoint?
Where the site packet can be found.
What is the FOCAS website or https://nihstrokenet.org/trials/focas/site-training?
Must remain up-to-date during the trial.
What are Regulatory Documents (CV, GCP, HSP, ML, protocol training (as required))?
This can be diagnosed at any time based on clinical changes/ clinically obtained imaging.
What is disease progression?
*steroids will be started for those in Group B
This is not a required specimen collection
What is CSF sample?
Imaging must be uploaded to WebDCU in this format.
What is DICOM format? (screenshots, jpeg and other image file formats cannot be used)
Password for all documents posted on the FOCAS website
What is Focastrial?
The process of exchanging information and ongoing communication between the investigator (researcher) and the potential research participant (subject).
What is the Informed Consent Process?
If the 6 month post stroke timepoint is done via video or telephone, these assessments should be collected.
Recovery Recurrence Questionnaire (RRQ), Tolerability questionnaire and AE/SAE collection (if any).
This is the total research blood volume collected for the study.
What is 10.5mL?
MRI/MRA scans are ideally performed on machines with this magnet strength.
What is 3T (most ideal) and 1.5T (least ideal, but allowed)?
*All imaging timepoints must be done using the same magnet strength
Timeframe that a SAE must be entered into WebDCU.
What is within 24 hours (of site becoming aware of the event)?
This is the duration breakdown of the corticosteroid treatment, with initial IV dosing followed by an oral taper.
What is 3 days of IV methylprednisolone followed by 4 weeks of oral taper of prednisolone?
The time window for collecting baseline blood samples.
What is within 24 hours of the 96 hour enrollment window? (Day 5 post stroke)
The highest priority MR imaging sequence
What is MRA?
These can be accessed via a QR code, a link in the ICF, or directly on the FOCAS website.
What are the FOCAS recruitment videos?
An event that involves increased risk of harm to participants or others, is unexpected and related, or possibly related to participation in research, and must be entered into the issues table within 24 hrs.
Promptly Reportable Events
These activities should be performed 24 hour post steroid treatment.
Medical chart abstraction (vital signs, serum glucose & electrolyte values), Tolerability Questionnaire, collection of AE/SAEs.
To prioritize the most important samples, blood sample types should be collected in this order at baseline.
What is serum, paxgene and EDTA (plasma)?
This is the primary endpoint for the study.
What is the change in FCASS from baseline to 1-month?
It is important that the 1-month scan is performed on the same magnet strength as the baseline MRA for this reason.
Document to be used to help complete Case Report Forms (CRFs) in WebDCU.
What is Data Collection Guidelines?
13 Sep 2025
What is the Continuing Review expiration date?