NCT02077582

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
• Phase: —
• Study type: Observational
• Enrollment: 410 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Stroke

Timeline

• Start date: 2013-09-01
• Primary completion: 2018-09-01
• Completion: 2018-12-01
• First posted: 2014-03-04
• Last updated: 2014-03-04

Locations

1 site across 1 country: Germany