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

April 10, 2019 updated by: Penumbra Inc.

Functional Outcome and Recovery After STROKE: The FIRST Trial

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

Study Overview

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Queen Mary Hospital
      • Shatin, Hong Kong, China
        • The Prince of Wales Hospital
    • Texas
      • Plano, Texas, United States, 75075
        • Texas Stroke Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
acute ischemic stroke
Patients presenting with symptoms of acute ischemic stroke within 8 hours from symptom onset and with an imaging-defined large cerebral vessel occlusion.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional outcome at 90 days after presentation as defined by a modified Rankin Score of 0-2.
Time Frame: 90 days after presentation
90 days after presentation

Secondary Outcome Measures

Outcome Measure
Time Frame
• 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.
Time Frame: Discharge and 90 days after presentation
Discharge and 90 days after presentation
All cause mortality
Time Frame: Dishcharge and 90 days after presentation
Dishcharge and 90 days after presentation
Incidence of symptomatic and asymptomatic hemorrhage
Time Frame: Dishcharge and 90 days after presentation
Dishcharge and 90 days after presentation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 23, 2010

First Submitted That Met QC Criteria

March 24, 2010

First Posted (Estimate)

March 25, 2010

Study Record Updates

Last Update Posted (Actual)

April 12, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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