The Oslo Acute Reperfusion Stroke Study (OSCAR) (OSCAR)

Prospective registry of clinical and radiological data in acute ischemic stroke patients after endovascular treatment.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Other: Endovascular treatment

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Anne Hege Aamodt; Phone Number: 97417734; Email: anne.hege.aamodt@gmail.com
• Study Contact Backup: Name: Brian Enriquez; Email: brienr@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital
    • Contact: Anne Hege Aamodt, MD PhD Prof; Phone Number: +47 23 07 00 00; Email: anhaam@ous-hf.no
    • Contact: Brian Enriquez, MD; Phone Number: +47 23 07 00 00; Email: brienr@ous-hf.no
    • Sub-Investigator: Thor H Skattør, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

acute ischemic stroke patients with proximal cerebral artery occlusion admitted for endovascular treatment.

Description

Inclusion Criteria:

• Age 18 years or older
• Patients with ischemic stroke and cerebral arterial occlusion treated with endovascular revascularization.
• All stroke severities and vascular distributions are eligible.
• Informed written consent signed by the patient, verbal consent from the patient as witnessed by a non-participating health care person or consent by the signature of the patient's family must be provided before inclusion. Patients for whom no informed consent can be obtained will not be included in the study but will be treated according to standard guidelines.

Exclusion criteria:

• Patient not eligible for the study or not available for follow-up assessments (e.g. non- resident).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale Score	Modified Rankin Scale Score (mRS), min 0, max 6	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institute of Health Stroke Scale Score	National Institute of Health Stroke Scale Score (NIHSS, min 0, max 42)	discharge
Death due to any cause	Mortality	3 months
Infarct volume	Infarct volume (ml)	1 day
Incidence of symptomatic intracranial hemorrhage	Incidence of symptomatic intracranial hemorrhage (SICH)	1 day
Volume of new areas of diffusion restriction	Volume of new areas of diffusion restriction	1 day
serious adverse events	serious adverse events	3 months

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2017
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 14, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

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: 2015-17637

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No