Non-Heme Iron Load Quantification in the Brain - MRI of Patients With Stroke

NCT01829386 | Completed DMC

• 3 other identifiers: HUM00067651R21NS099684R21NS104663
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine if MRI imaging can be used to estimate the amount of iron in areas of the brain affected by a stroke. This may help future patients if the scan can be used to predict the amount of brain damage and therefore the effects on the patient. New research treatments are being used to reduce the amount of iron build-up in the brain. The effects of that treatment may also be estimated using new MRI techniques.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Assessment of iron levels in patients with hemorrhagic stroke

  Create a non-invasive imaging modality to assess for iron levels in patients with hemorrhagic stroke. Validation of quantification of non heme iron in the brain.

  30 days

Study Arms (1)

Non heme iron levels on MRI

Intervention: MRI scans To develop a reliable MR based measurement of Non-heme iron in brain tissue of patients with hemorrhagic stroke : on day 1, 14 and 30 after stroke to assess the non heme iron levels on MRI. To evaluate the role of iron chelators following a hemorrhagic stroke/parenchymal hemorrhage.

Other: MRI scans with non heme iron levels

Interventions

MRI scans with non heme iron levels OTHER

MRI scans of the head will be performed to determine the amount of Non heme iron in areas of the brain of hemorrhagic stroke patients and hopefully predict the amount of brain damage. Each MRI will take up to 1 hour to complete and will be done on day 3, day 14 and day 30. Some of the (MRIs) Magnetic Resonance Imaging will be clinically indicated and sequences will be added to the clinical scan with each sequence adding 10 minutes to the scan. Some sequences will be done only for research.

Non heme iron levels on MRI

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes men and women, aged 18-85 who have had a hemorrhagic stroke and who can safely have an MRI scan.

You may qualify if:

• \. Males and females between the age of 18 and 85 who have suffered a stroke confirmed by a CT of the head.

You may not qualify if:

• You cannot take part in this study unless you have evidence of having a stroke (hemorrhage in your brain).
• You cannot take part in this study if you are not able to safely have an MRI exam.
• Women cannot take part in this study if they are pregnant.
• Women may not participate in this study if they are attempting to become pregnant or think they might be pregnant. We will provide a one-time pregnancy test for anyone who is uncertain about being pregnant.
• You cannot take part in this study if you have evidence of a large amount of calcifications found on CT exams that have been performed as part of the clinical evaluation for your current condition.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (7)

• Novakovic N, Linzey JR, Chenevert TL, Gemmete JJ, Troost JP, Xi G, Keep RF, Pandey AS, Chaudhary N. White Matter Survival within and around the Hematoma: Quantification by MRI in Patients with Intracerebral Hemorrhage. Biomolecules. 2021 Jun 18;11(6):910. doi: 10.3390/biom11060910.

  PMID: 34207338 BACKGROUND

• Novakovic N, Wilseck ZM, Chenevert TL, Xi G, Keep RF, Pandey AS, Chaudhary N. Assessing early erythrolysis and the relationship to perihematomal iron overload and white matter survival in human intracerebral hemorrhage. CNS Neurosci Ther. 2021 Oct;27(10):1118-1126. doi: 10.1111/cns.13693. Epub 2021 Jun 17.

  PMID: 34145764 BACKGROUND

• Chaudhary N, Pandey AS, Wang X, Xi G. Hemorrhagic stroke-Pathomechanisms of injury and therapeutic options. CNS Neurosci Ther. 2019 Oct;25(10):1073-1074. doi: 10.1111/cns.13225. No abstract available.

  PMID: 31583834 BACKGROUND

• Chaudhary N, Pandey AS, Griauzde J, Gemmete JJ, Chenevert TL, Keep RF, Xi G. Brain tissue iron quantification by MRI in intracerebral hemorrhage: Current translational evidence and pitfalls. J Cereb Blood Flow Metab. 2019 Mar;39(3):562-564. doi: 10.1177/0271678X18818911. Epub 2018 Dec 12.

  PMID: 30540218 BACKGROUND

• Koduri S, Keep RF, Hua Y, Chaudhary N, Pandey AS, Xi G. The Two Faces of Estrogen in Experimental Hemorrhagic Stroke. Transl Stroke Res. 2022 Jun;13(3):362-363. doi: 10.1007/s12975-021-00942-0. Epub 2021 Sep 16. No abstract available.

  PMID: 34528179 BACKGROUND

• Chen J, Koduri S, Dai S, Toyota Y, Hua Y, Chaudhary N, Pandey AS, Keep RF, Xi G. Intra-hematomal White Matter Tracts Act As a Scaffold for Macrophage Infiltration After Intracerebral Hemorrhage. Transl Stroke Res. 2021 Oct;12(5):858-865. doi: 10.1007/s12975-020-00870-5. Epub 2020 Oct 22.

  PMID: 33094829 BACKGROUND

• Wei J, Novakovic N, Chenevert TL, Xi G, Keep RF, Pandey AS, Chaudhary N. Perihematomal brain tissue iron concentration measurement by MRI in patients with intracerebral hemorrhage. CNS Neurosci Ther. 2020 Sep;26(9):896-901. doi: 10.1111/cns.13395. Epub 2020 May 21.

  PMID: 32436273 RESULT

MeSH Terms

Conditions

Stroke

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Neeraj Chaudhary, MD MRCS FRCR

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 11, 2013
• Study Start: January 1, 2013
• Primary Completion: August 23, 2022
• Study Completion: August 23, 2022
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)