Longitudinal MRI Examinations of Patients With Brain Ischemia and Blood Brain Barrier Permeability (LOBI-BBB)

March 3, 2014 updated by: Jochen B. Fiebach, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

410

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 12203
        • Recruiting
        • Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin
        • Contact:
        • Principal Investigator:
          • Jochen B. Fiebach, MD
        • Sub-Investigator:
          • Kersten Villringer, MD
        • Sub-Investigator:
          • Ann-Christin Ostwaldt, MSc
        • Sub-Investigator:
          • Ivana Galinovic, MD PhD
        • Sub-Investigator:
          • Benjamin Hotter, MD
        • Sub-Investigator:
          • Lars Neeb, MD
        • Sub-Investigator:
          • Claudia E. Kunze
        • Sub-Investigator:
          • Ramanan Ganeshan, MD
        • Sub-Investigator:
          • Peter Brunecker, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic. Patients presenting with acute (<24h) transient ischemic attack or stroke at the emergency ward, Charité Campus Benjamin Franklin

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • MRI contraindication, age < 18 years, intracranial hemorrhages

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical outcome measured with the National Institutes of Health Stroke Scale (NIHSS)
Time Frame: on follow-up examination day 5-7
on follow-up examination day 5-7
clinical outcome measured with the modified Rankin Scale (mRS)
Time Frame: on day 90
conducted as telephone interview
on day 90

Secondary Outcome Measures

Outcome Measure
Time Frame
final lesion volume (measured on FLAIR images)
Time Frame: on follow-up examination day 5-7
on follow-up examination day 5-7

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
volumes of hypoperfusion on resting state-MRI perfusion maps
Time Frame: on follow-up examinations day 1 and 2
outcome measure for resting state-MRI sub-project only
on follow-up examinations day 1 and 2
blood flow parameters in occluded, contralateral and (partially) recanalized vessels
Time Frame: on follow-up examinations day 1 and 2
outcome measure for quantitative Angiography sub-project only
on follow-up examinations day 1 and 2
pH values in the region of diffusion restriction and in the region of final infarct
Time Frame: on follow-up examinations day 1 and 2
outcome measure for the pH-Imaging sub-project only
on follow-up examinations day 1 and 2
quantified values for contrast agent enhancement in the stroke lesion and on the contralateral side
Time Frame: on follow-up examination day 1 and 2
outcome measure for the T1-Dynamic sub-project only
on follow-up examination day 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

German Federal Ministry of Education and Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

February 23, 2014

First Submitted That Met QC Criteria

March 3, 2014

First Posted (Estimate)

March 4, 2014

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

March 3, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOBI-BBB
  • EA1/200/13 (Other Identifier: Ethics Comittee of the Charité Universitätsmedizin Berlin)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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