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

• Conditions: Cerebral Stroke

• Registration Number: NCT02077582
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-02-23
• Status Verified: 2014-03
• Study First Submitted QC: 2014-03-03
• Last Update Submitted: 2014-03-03
• Study First Posted: 2014-03-04
• Last Update Posted: 2014-03-04
• Primary Completion: 2018-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 410

Inclusion Criteria

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

Exclusion Criteria

• MRI contraindication, age < 18 years, intracranial hemorrhages

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 90	conducted as telephone interview

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin; 🇩🇪 Berlin, Germany