MRI Repository for Acute Stroke Clinical and Research Applications

Stroke is one of the leading causes of death and long-term disability. A major unresolved problem in MRI-based stroke assessment is to relate image features to brain function in a way that can properly guide stratification for treatment and rehabilitation. This requires extracting meaningful and reproducible models of brain function from stroke images, a daunting task severely hindered by the great variability of lesion frequency and pattern. Large datasets are imperative to uncover possible lesion-function relationships.

In this project the investigators will create a large database of acute strokes MRIs. The investigators will retrospectively archive an estimated 3,000 MRIs of patients with acute stroke, acquired at the Johns Hopkins Hospital, 2009-2019. This dataset will include 1.5 and 3 Tesla scans, diverse protocols and sequences (e.g., diffusion and perfusion weighted images (DWI/b0, PWI), T1, T2, FLAIR, susceptibility weighted images), with typical clinical low voxel resolution (4-7 mm3). Lesions will be initially delineated on DWI/b0, the most informative MRI sequence for acute stroke. After anonymization and defacing, two trained evaluators will perform the manual lesion segmentation. Two expert neuroradiologists will create consensual structured radiological reports with information about stroke type and location according to different criteria (e.g., 34 brain structures and 11 vascular territories). The investigators will also archive structured information from discharge (demographics, laboratory, and neurological evaluation of patients, including NIH stroke scale and modified Rankin scale, mRS), as well as the 90-days follow-up mRS.

Study Overview

• Status: Withdrawn
• Conditions: Stroke, Acute

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients admitted at Hopkins Stroke center with the diagnosis of acute brain stroke

Description

Inclusion Criteria:

• patients admitted at Hopkins Stroke center with the diagnosis of acute brain stroke

Exclusion Criteria:

• Not performed MRI

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic and clinical data obtained via chart review	This is a hospital based retrospective collection of data for acute stroke from a ten-year period retrospective review of participant charts.	1 year

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Andreia V Faria, MD, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: February 1, 2021

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
• Other Study ID Numbers: IRB00228775

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators will make the database public in sharing neuroimaging platforms after anonymization, including defacing.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

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