Longitudinal MRI Examinations of Patients With Brain Ischemia and Blood Brain Barrier Permeability

NCT ID: NCT02077582

Last Updated: 2014-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

410 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-12-31

Brief Summary

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The objective of this trial is to visualize blood brain barrier function and metabolic changes in the first days after ischemic stroke with new investigational MRI sequences.

Detailed Description

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In this study the investigators will be examining acute ischemic stroke patients on the first and second day after symptom onset using repetitive MRI examinations to visualize blood brain barrier function and metabolic changes of the brain in 5 sub-projects, each containing a specific MRI protocol with one of the following new MRI sequences:

1. T1-Dynamics (measuring disruptions of the blood-brain barrier)
2. pH-imaging (measuring metabolic changes, acidosis)
3. Resting-state MRI (measuring changes in the cerebral perfusion)
4. Quantitative MRI-Angiography (quantification of blood flow in single vessels)
5. Diffusion Tensor Imaging (DTI) for patients with Anterior Choroidal Artery (AChA)-Infarcts (quantification of damage of white matter tracts)

Each sub-projects will be conducted in blocks of a specific time span. Morphological outcome will be assessed at day 5-7. Clinical outcome will be assessed at day 5-7 and day 90. The association of the new imaging parameter with the clinical and morphological outcome measures will be analysed. No specific intervention is assigned to the subjects by the investigators of the study.

Conditions

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Cerebral Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Suspected stroke or transient ischemic attack (TIA) within 24h from symptom onset

Exclusion Criteria

* MRI contraindication, age \< 18 years, intracranial hemorrhages
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Jochen B. Fiebach

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jochen B: Fiebach, MD

Role: CONTACT

004930 8445 4088

Kersten Villringer, MD

Role: CONTACT

004930 8445 4080

Facility Contacts

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Jochen B. Fiebach, MD

Role: primary

004930 8445 4088

References

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Fan AP, Khalil AA, Fiebach JB, Zaharchuk G, Villringer A, Villringer K, Gauthier CJ. Elevated brain oxygen extraction fraction measured by MRI susceptibility relates to perfusion status in acute ischemic stroke. J Cereb Blood Flow Metab. 2020 Mar;40(3):539-551. doi: 10.1177/0271678X19827944. Epub 2019 Feb 7.

Reference Type DERIVED
PMID: 30732551 (View on PubMed)

Villringer K, Florczak-Rzepka M, Grittner U, Brunecker P, Tepe H, Nolte CH, Fiebach JB. Characteristics associated with outcome in patients with first-ever posterior fossa stroke. Eur J Neurol. 2018 Jun;25(6):818-824. doi: 10.1111/ene.13596. Epub 2018 Mar 25.

Reference Type DERIVED
PMID: 29431878 (View on PubMed)

Ganeshan R, Nave AH, Scheitz JF, Schindlbeck KA, Haeusler KG, Nolte CH, Villringer K, Fiebach JB. Assessment of thrombus length in acute ischemic stroke by post-contrast magnetic resonance angiography. J Neurointerv Surg. 2018 Aug;10(8):756-760. doi: 10.1136/neurintsurg-2017-013454. Epub 2017 Nov 18.

Reference Type DERIVED
PMID: 29151041 (View on PubMed)

Khalil AA, Ostwaldt AC, Nierhaus T, Ganeshan R, Audebert HJ, Villringer K, Villringer A, Fiebach JB. Relationship Between Changes in the Temporal Dynamics of the Blood-Oxygen-Level-Dependent Signal and Hypoperfusion in Acute Ischemic Stroke. Stroke. 2017 Apr;48(4):925-931. doi: 10.1161/STROKEAHA.116.015566. Epub 2017 Mar 8.

Reference Type DERIVED
PMID: 28275197 (View on PubMed)

Villringer K, Sanz Cuesta BE, Ostwaldt AC, Grittner U, Brunecker P, Khalil AA, Schindler K, Eisenblatter O, Audebert H, Fiebach JB. DCE-MRI blood-brain barrier assessment in acute ischemic stroke. Neurology. 2017 Jan 31;88(5):433-440. doi: 10.1212/WNL.0000000000003566. Epub 2016 Dec 28.

Reference Type DERIVED
PMID: 28031392 (View on PubMed)

Other Identifiers

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EA1/200/13

Identifier Type: OTHER

Identifier Source: secondary_id

LOBI-BBB

Identifier Type: -

Identifier Source: org_study_id

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