StrokeNCT01829386
Non-Heme Iron Load Quantification in the Brain - MRI of Patients With Stroke
An observational study of Stroke, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- MRI scans with non heme iron levels
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 23 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 1. Males and females between the age of 18 and 85 who have suffered a stroke confirmed by a CT of the head.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: Non-Heme Iron Load Quantification in the Brain on MRI in Patients With Hemorrhagic Stroke
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.
Read the detailed description
Hemorrhagic stroke has devastating consequences. The mechanisms resulting in early and delayed brain injury following a hemorrhagic stroke is poorly understood. One of the mechanisms demonstrated in
animal studies points towards deposition of iron in the brain tissue following hemorrhage. Preliminary data in animal studies also support a favorable effect of iron chelate agents. Iron chelate agents are compounds that bind iron to them and may show the extent of neural tissue damage.
Initial results of human trials based on this hypothesis demonstrated the safety of increasing amounts of desferroxamine given to human patients. The evaluation of iron chelate agents for hemorrhagic stroke is entering into phase II/III trials.
There is no modality at this date that can quantify the iron in tissue non invasively. Some preliminary studies have demonstrated the role of MRI in identifying parenchymal iron deposition in traumatic brain injury.
We propose to validate an MRI based method to not only identify but also quantify the non heme iron levels deposited in brain tissue following hemorrhagic stroke. Once validated this method will be a robust mechanism to reliably quantify tissue iron in the brain which then can be closely followed through iron chelate therapy in a trial setting.
- Conditions
- Stroke
- Being tested
- MRI scans with non heme iron levels
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scans with non heme iron levelsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MRI scans with non heme iron levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startJan 2013
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neeraj Chaudhary MD MRCS FRCR, University of Michigan
- Investigators
- Neeraj Chaudhary, MD MRCS FRCR, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829386
- Sponsor's protocol ID
- HUM00067651
- Other IDs
- R21NS099684, R21NS104663
- Status last verified
- Aug 2023
- First submitted
- 8 Apr 2013
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34207338Novakovic 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.
PubMed 34145764Chaudhary 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.
PubMed 31583834Chaudhary 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.
PubMed 30540218Koduri 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.
PubMed 34528179Chen 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.
PubMed 33094829Wei 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.
PubMed 32436273
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Heme Iron Load Quantification in the Brain on MRI in Patients With Hemorrhagic Stroke
- ClinicalTrials.gov ID
- NCT01829386
- Acronym / sponsor ID
- HUM00067651
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jan 2013
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 11 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hemorrhagic stroke has devastating consequences. The mechanisms resulting in early and delayed brain injury following a hemorrhagic stroke is poorly understood. One of the mechanisms demonstrated in
animal studies points towards deposition of iron in the brain tissue following hemorrhage. Preliminary data in animal studies also support a favorable effect of iron chelate agents. Iron chelate agents are compounds that bind iron to them and may show the extent of neural tissue damage.
Initial results of human trials based on this hypothesis demonstrated the safety of increasing amounts of desferroxamine given to human patients. The evaluation of iron chelate agents for hemorrhagic stroke is entering into phase II/III trials.
There is no modality at this date that can quantify the iron in tissue non invasively. Some preliminary studies have demonstrated the role of MRI in identifying parenchymal iron deposition in traumatic brain injury.
We propose to validate an MRI based method to not only identify but also quantify the non heme iron levels deposited in brain tissue following hemorrhagic stroke. Once validated this method will be a robust mechanism to reliably quantify tissue iron in the brain which then can be closely followed through iron chelate therapy in a trial setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non heme iron levels on MRI | – | Other: MRI scans with non heme iron levelsIntervention: 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 1. Males and females between the age of 18 and 85 who have suffered a stroke confirmed by a CT of the head.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scans with non heme iron levelsMRI 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. | Other | Non heme iron levels on MRI |
Primary outcome
Assessment of iron levels in patients with hemorrhagic stroke
Time frame: 30 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Background: PubMed 34207338Novakovic 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.
- Background: PubMed 34145764Novakovic 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.
- Background: PubMed 31583834Chaudhary 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.
- Background: PubMed 30540218Chaudhary 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.
- Background: PubMed 34528179Koduri 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.
- Background: PubMed 33094829Chen 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.
- Results publication: PubMed 32436273Wei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neeraj Chaudhary, MD MRCS FRCR principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of iron levels in patients with hemorrhagic stroke (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01829386, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.