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Clinical Trials/NCT02077582
NCT02077582
Unknown
Not Applicable

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

Charite University, Berlin, Germany1 site in 1 country410 target enrollmentSeptember 2013
ConditionsCerebral Stroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Stroke
Sponsor
Charite University, Berlin, Germany
Enrollment
410
Locations
1
Primary Endpoint
clinical outcome measured with the modified Rankin Scale (mRS)
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
December 2018
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jochen B. Fiebach

MD

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

clinical outcome measured with the modified Rankin Scale (mRS)

Time Frame: on day 90

conducted as telephone interview

clinical outcome measured with the National Institutes of Health Stroke Scale (NIHSS)

Time Frame: on follow-up examination day 5-7

Secondary Outcomes

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

Study Sites (1)

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