A Clinical Trial to Assess the Acute Safety and Functional Outcome and Recovery After STROKE: The FIRST Trial "FIRST"

Active, not recruiting

Phase N/A Results N/A

Trial Description

Current literature has only limited information on the natural history of acute ischemic stroke from large vessel occlusion in a stroke cohort who presents within 8 hours from symptom onset, particularly on 90 day functional outcome as defined by the mRS. Data from this trial will advance our knowledge on this important topic and may serve as a bench mark for future trials

Conditions

Interventions

  • Current standard of care for acute ischemic stroke other than IV rtPA or other IA therapies Other
    Intervention Desc: The objective of this study is to determine the natural history of acute ischemic stroke from large vessel thromboembolism in the brain. Patients with current standard of care other than IV rtPA or IA therapies will be studied.
    ARM 1: Kind: Experimental
    Label: acute ischemic stroke
    Description: Patients presenting with symptoms of acute ischemic stroke within 8 hours from symptom onset and with an imaging-defined large cerebral vessel occlusion.

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial Population

Patients presenting with symptoms of acute ischemic stroke within 8 hours from symptom onset and with an imaging-defined large cerebral vessel occlusion and a known infarct volume will be enrolled and followed for 90-days.

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional outcome at 90 days after presentation as defined by a modified Rankin Score of 0-2. 90 days after presentation No
Secondary • Good neurological recovery as defined by a NIHSS score of 0-1 at discharge or a 10-point or more improvement in this scale at discharge. Discharge and 90 days after presentation No
Secondary All cause mortality Dishcharge and 90 days after presentation No
Secondary Incidence of symptomatic and asymptomatic hemorrhage Dishcharge and 90 days after presentation No

Sponsors