A Study of Survival and Outcome After Stroke (SOS)

The SOS Study: A Study of Survival and Outcome After Stroke

The objective of this study is to determine the natural history of acute ischemic stroke from large vessel thromboembolism in the brain. The target population is a stroke cohort with a known infarct volume who presents within 8 hours from symptom onset with a NIH Stroke Scale (NIHSS) score >10 who are eligible for mechanical thrombectomy but without receiving the treatment. Functional outcome as defined by the modified Rankin Scale (mRS) of all enrolled patients will be followed for 90 days after the index event.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke

Detailed Description

The objective of this observational study is to determine the natural history of acute ischemic stroke from large vessel thromboembolism in the brain. The target population is a stroke cohort with a known infarct volume who presents within 8 hours from symptom onset with a NIH Stroke Scale (NIHSS) score >10. Functional outcome as defined by the modified Rankin Scale (mRS) of all enrolled patients will be followed for 90 days after the index event. This is a prospective, single arm, multi-center trial. Up to 200 patients at up to 30 centers will be enrolled in the study. It is anticipated that up to 150 evaluable patients will be needed for analysis. The sample size estimate is based on the primary study functional outcome at 90 days as defined by a mRS of 0-2. Assuming that this observational study will have as outcome of 25% (37/150) mRS 0-2 at day 90, the expected two-sided exact binomial confidence interval is (18%, 32%). This sample size is adequate to estimate the mRS outcome of 0-2 at day 90 for the natural history of acute ischemic stroke.

• Study Type: Observational
• Enrollment (Actual): 142

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 9DU
    • Acute Vascular Imaging Centre, John Radcliffe Hospital, University of Oxford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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 supra-clinoid segment of the ICA through the M1 segment of the MCA.
• 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 > 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 >1
• Known severe allergy to contrast media
• Uncontrolled hypertension (defined as systolic blood pressure >185 mmHg or diastolic blood pressure >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 was thought to be less than 90 days prior to stroke due to non-stroke illness
• Participation in another clinical investigation that could confound the evaluation of the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Standard of Care; Standard of Care for stroke except mechanical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with a modified Rankin score of 2 or less	90 days after the procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
NIHSS score of 0-1 or a 10 or more points improvement	Discharge
All cause mortality	90 days post-procedure
Incidents of symptomatic and asymptomatic intracranial hemorrhage	90 days post-procedure

Collaborators and Investigators

• Sponsor: Penumbra Inc.
• Investigators: Principal Investigator: Iris Q Grunwald, MD, The John Radcliffe Hospital, Oxford, UK

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): December 22, 2016
• Study Completion (Actual): December 22, 2016

Study Registration Dates

• First Submitted: August 31, 2010
• First Submitted That Met QC Criteria: September 1, 2010
• First Posted (Estimate): September 2, 2010

Study Record Updates

• Last Update Posted (Actual): April 12, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: CLP2818