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

Cerebral Stroke Clinical Trial

— LOBI-BBB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02077582
• Other study ID #: LOBI-BBB
• Secondary ID: EA1/200/13
• Status: Recruiting
• Phase: N/A
• First received: February 23, 2014
• Last updated: March 3, 2014
• Start date: September 2013
• Est. completion date: December 2018

Study information

• Verified date: March 2014
• Source: Charite University, Berlin, Germany
• Contact: Jochen B: Fiebach, MD
• Phone: 004930 8445 4088
• Email: jochen.fiebach[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 410
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Stroke
• Stroke

Locations

Country	Name	City	State
Germany	Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	volumes of hypoperfusion on resting state-MRI perfusion maps	outcome measure for resting state-MRI sub-project only	on follow-up examinations day 1 and 2	No
Other	blood flow parameters in occluded, contralateral and (partially) recanalized vessels	outcome measure for quantitative Angiography sub-project only	on follow-up examinations day 1 and 2	No
Other	pH values in the region of diffusion restriction and in the region of final infarct	outcome measure for the pH-Imaging sub-project only	on follow-up examinations day 1 and 2	No
Other	quantified values for contrast agent enhancement in the stroke lesion and on the contralateral side	outcome measure for the T1-Dynamic sub-project only	on follow-up examination day 1 and 2	No
Primary	clinical outcome measured with the National Institutes of Health Stroke Scale (NIHSS)		on follow-up examination day 5-7	No
Primary	clinical outcome measured with the modified Rankin Scale (mRS)	conducted as telephone interview	on day 90	No
Secondary	final lesion volume (measured on FLAIR images)		on follow-up examination day 5-7	No

External Links

•   Homepage Center for Stroke Research