Clinical trial NCT02077582: Longitudinal MRI Examinations of Patients With Brain Ischemia and Blood Brain Barrier Permeability
Official title: Longitudinal Observation of Brain Ischemia and Blood Brain Barrier Permeability in the Acute Phase of Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Stroke
Keywords: acute ischemic stroke
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2014-03-04
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: clinical outcome measured with the National Institutes of Health Stroke Scale (NIHSS)
timeFrame: on follow-up examination day 5-7
measure: clinical outcome measured with the modified Rankin Scale (mRS)
timeFrame: on day 90
Secondary outcomes:
measure: final lesion volume (measured on FLAIR images)
timeFrame: on follow-up examination day 5-7
Other outcomes:
measure: volumes of hypoperfusion on resting state-MRI perfusion maps
timeFrame: on follow-up examinations day 1 and 2
measure: blood flow parameters in occluded, contralateral and (partially) recanalized vessels
timeFrame: on follow-up examinations day 1 and 2
measure: pH values in the region of diffusion restriction and in the region of final infarct
timeFrame: on follow-up examinations day 1 and 2
measure: quantified values for contrast agent enhancement in the stroke lesion and on the contralateral side
timeFrame: on follow-up examination day 1 and 2
Locations:
city: Berlin
country: Germany
facility: Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.