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| ID | Type | Description | Link |
|---|---|---|---|
| EA1/200/13 | Other Identifier | Ethics Comittee of the Charité Universitätsmedizin Berlin |
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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
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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.
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:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | conducted as telephone interview | on day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| final lesion volume (measured on FLAIR images) | on follow-up examination day 5-7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| blood flow parameters in occluded, contralateral and (partially) recanalized vessels |
Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic. Patients presenting with acute (<24h) transient ischemic attack or stroke at the emergency ward, Charité Campus Benjamin Franklin
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jochen B: Fiebach, MD | Contact | 004930 8445 4088 | jochen.fiebach@charite.de | |
| Kersten Villringer, MD | Contact | 004930 8445 4080 | kersten.villringer@charite.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin | Recruiting | Berlin | State of Berlin | 12203 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30732551 | Derived | 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. | |
| 29431878 | Derived |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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2x 2ml plasma and 2x 2ml serum per patient
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 | 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 | outcome measure for the T1-Dynamic sub-project only | on follow-up examination day 1 and 2 |
| 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. |
| 29151041 | Derived | 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. |
| 28275197 | Derived | 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. |
| 28031392 | Derived | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |