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Cerebral StrokeLOBI-BBBNCT02077582

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

An observational study of Cerebral Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cerebral Stroke
How many people
410 participants
Where
1 siteGermany
Study dates
Sep 2013to Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • MRI contraindication, age < 18 years, intracranial hemorrhages

Trial locations and contacts

1 site in 1 country.

Jochen B: Fiebach, MD contact

004930 8445 4088

jochen.fiebach@charite.de

Kersten Villringer, MD contact

004930 8445 4080

kersten.villringer@charite.de

Germany1 site, 1 recruiting

  • Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin

    Berlin, State of Berlin, 12203

    Jochen B. Fiebach, MD, 004930 8445 4088, jochen.fiebach@charite.de

    Jochen B. Fiebach, MD

    Recruiting

Other trials in Germany

About this study

Official title: 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.

Read the 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
Keywords
acute ischemic stroke
Medical subject headings
Stroke, Ischemic Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: on follow-up examination day 5-7

  2. clinical outcome measured with the modified Rankin Scale (mRS)

    conducted as telephone interview

    Measured: on day 90

Secondary outcomes (1)

  1. final lesion volume (measured on FLAIR images)

    Measured: on follow-up examination day 5-7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2014 (estimated)
  2. Study startSep 2013
  3. Primary completionSep 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
410 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02077582
Sponsor's protocol ID
LOBI-BBB
Other IDs
EA1/200/13
Acronym
LOBI-BBB
Status last verified
Mar 2014
First submitted
23 Feb 2014
Last updated
4 Mar 2014
Results posted
No
Data monitoring committee
No

Publications

  • Fan AP, Khalil AA, Fiebach JB, Zaharchuk G, Villringer A, Villringer K, Gauthier CJ. Elevated brain oxygen extraction fraction measured by MRI susceptibility relates to perfusion status in acute ischemic stroke. J Cereb Blood Flow Metab. 2020 Mar;40(3):539-551. doi: 10.1177/0271678X19827944. Epub 2019 Feb 7.

    PubMed 30732551

  • Villringer K, Florczak-Rzepka M, Grittner U, Brunecker P, Tepe H, Nolte CH, Fiebach JB. Characteristics associated with outcome in patients with first-ever posterior fossa stroke. Eur J Neurol. 2018 Jun;25(6):818-824. doi: 10.1111/ene.13596. Epub 2018 Mar 25.

    PubMed 29431878

  • Ganeshan R, Nave AH, Scheitz JF, Schindlbeck KA, Haeusler KG, Nolte CH, Villringer K, Fiebach JB. Assessment of thrombus length in acute ischemic stroke by post-contrast magnetic resonance angiography. J Neurointerv Surg. 2018 Aug;10(8):756-760. doi: 10.1136/neurintsurg-2017-013454. Epub 2017 Nov 18.

    PubMed 29151041

  • Khalil AA, Ostwaldt AC, Nierhaus T, Ganeshan R, Audebert HJ, Villringer K, Villringer A, Fiebach JB. Relationship Between Changes in the Temporal Dynamics of the Blood-Oxygen-Level-Dependent Signal and Hypoperfusion in Acute Ischemic Stroke. Stroke. 2017 Apr;48(4):925-931. doi: 10.1161/STROKEAHA.116.015566. Epub 2017 Mar 8.

    PubMed 28275197

  • Villringer K, Sanz Cuesta BE, Ostwaldt AC, Grittner U, Brunecker P, Khalil AA, Schindler K, Eisenblatter O, Audebert H, Fiebach JB. DCE-MRI blood-brain barrier assessment in acute ischemic stroke. Neurology. 2017 Jan 31;88(5):433-440. doi: 10.1212/WNL.0000000000003566. Epub 2016 Dec 28.

    PubMed 28031392

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jochen B: Fiebach, MD (004930 8445 4088, jochen.fiebach@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical outcome measured with the National Institutes of Health Stroke Scale (NIHSS) (time frame: on follow-up examination day 5-7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02077582, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.

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