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

Longitudinal Observation of Brain Ischemia and Blood Brain Barrier Permeability in the Acute Phase of Ischemic Stroke

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02077582
Acronym
LOBI-BBB
Enrollment
410
Registered
2014-03-04
Start date
2013-09-30
Completion date
2018-12-31
Last updated
2014-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Stroke

Keywords

acute ischemic stroke

Brief summary

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

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.

Interventions

None listed

Sponsors

German Federal Ministry of Education and Research
CollaboratorOTHER_GOV
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* MRI contraindication, age \< 18 years, intracranial hemorrhages

Design outcomes

Primary

MeasureTime frameDescription
clinical outcome measured with the National Institutes of Health Stroke Scale (NIHSS)on follow-up examination day 5-7
clinical outcome measured with the modified Rankin Scale (mRS)on day 90conducted as telephone interview

Secondary

MeasureTime frame
final lesion volume (measured on FLAIR images)on follow-up examination day 5-7

Other

MeasureTime frameDescription
volumes of hypoperfusion on resting state-MRI perfusion mapson follow-up examinations day 1 and 2outcome measure for resting state-MRI sub-project only
quantified values for contrast agent enhancement in the stroke lesion and on the contralateral sideon follow-up examination day 1 and 2outcome measure for the T1-Dynamic sub-project only
blood flow parameters in occluded, contralateral and (partially) recanalized vesselson follow-up examinations day 1 and 2outcome measure for quantitative Angiography sub-project only
pH values in the region of diffusion restriction and in the region of final infarcton follow-up examinations day 1 and 2outcome measure for the pH-Imaging sub-project only

Countries

Germany

Contacts

Primary ContactJochen B: Fiebach, MD
jochen.fiebach@charite.de004930 8445 4088
Backup ContactKersten Villringer, MD
kersten.villringer@charite.de004930 8445 4080

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026