MRI Repository for Acute Stroke Clinical and Research Applications

Stroke, Acute Clinical Trial

Official title:

MRI Repository for Acute Stroke Clinical and Research Applications

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04144530
• Other study ID #: IRB00228775
• Status: Withdrawn
• Start date: August 2021
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Not performed MRI

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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