Clinical trial NCT01092819: A Clinical Trial to Assess the Acute Safety and Functional Outcome and Recovery After STROKE: The FIRST Trial
Official title: Functional Outcome and Recovery After STROKE: The FIRST Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: acute ischemic stroke, large vessel occlusion, natural history, functional outcome
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-25
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* From 18 to 85 years of age.
* Evidence of proximal anterior circulation large vessel occlusion (TIMI 0-1)(TICI 0-1) from CT Angiography. Target vessel occlusion may include the anterior circulation.
* Presented with symptoms consistent with acute ischemic stroke within 8 hours of symptom onset. Patients who presented within 3 hours must be ineligible or refractory to IV rtPA therapy.
* At time of enrollment, neurological deficit resulting in an NIH Stroke Scale (NIHSS) score greater than 10
* Known core infarct volume assessed by CTP, CTA or DWI scans

Exclusion Criteria:

* History of stroke in the past 3 months.
* Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score greater than 1
* Known severe allergy to contrast media
* Uncontrolled hypertension (defined as systolic blood pressure greater than 185 mmHg or diastolic blood pressure less than 110 mmHg)
* CT evidence of the following conditions before enrollment:

  * Significant mass effect with midline shift
  * Evidence of intracranial hemorrhage
* Treated with endovascular therapy for acute stroke
* Life expectancy less than 90 days
* Participation in another clinical investigation that could confound the evaluation of the study

Primary outcomes:
measure: Functional outcome at 90 days after presentation as defined by a modified Rankin Score of 0-2.
timeFrame: 90 days after presentation
Secondary outcomes:
measure: • 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.
timeFrame: Discharge and 90 days after presentation
measure: All cause mortality
timeFrame: Dishcharge and 90 days after presentation
measure: Incidence of symptomatic and asymptomatic hemorrhage
timeFrame: Dishcharge and 90 days after presentation
Other outcomes:
Locations:
city: Plano
country: United States
facility: Texas Stroke Institute
state: Texas
city: Hong Kong
country: China
facility: Queen Mary Hospital
state: Hong Kong
city: Shatin
country: China
facility: The Prince of Wales Hospital
state: Hong Kong
Study officials:
affiliation: Penumbra Inc.
name: Siu Po Sit, PhD
role: STUDY_DIRECTOR
References: