Showing papers by "Thomas Nägele published in 2017"

Apixaban for treatment of embolic stroke of undetermined source (ATTICUS randomized trial): Rationale and study design:

Abstract: Rationale Optimal secondary prevention of embolic stroke of undetermined source is not established. The current standard in these patients is acetylsalicylic acid, despite high prevalence of yet undetected paroxysmal atrial fibrillation. Aim The ATTICUS randomized trial is designed to determine whether the factor Xa inhibitor apixaban administered within 7 days after embolic stroke of undetermined source, is superior to acetylsalicylic acid for prevention of new ischemic lesions documented by brain magnetic resonance imaging within 12 months after index stroke. Design Prospective, randomized, blinded, parallel-group, open-label, German multicenter phase III trial in approximately 500 patients with embolic stroke of undetermined source. A key inclusion criterion is the presence or the planned implantation of an insertable cardiac monitor. Patients are 1:1 randomized to apixaban or acetylsalicylic acid and treated for a 12-month period. It is an event-driven trial aiming for core-lab adjudicated primary outcome events. Study outcomes The primary outcome is the occurrence of at least one new ischemic lesion identified by axial T2-weighted FLAIR magnetic resonance imaging and/or axial DWI magnetic resonance imaging at 12 months when compared with the baseline magnetic resonance imaging. Key secondary outcomes are the combination of recurrent ischemic strokes, hemorrhagic strokes, systemic embolism; combination of MACE including recurrent stroke, myocardial infarction, and cardiovascular death and combination of major and clinically relevant non-major bleeding defined according to ISTH, and change of cognitive function and quality of life (EQ-5D, Stroke Impact Scale). Discussion Embolic stroke of undetermined source is caused by embolic disease and associated with a high risk of recurrent ischemic strokes and clinically silent cerebral ischemic lesions. ATTICUS will investigate the impact of atrial fibrillation detected by insertable cardiac monitor and the effects of early anticoagulation with apixaban compared with antiplatelet therapy with acetylsalicylic acid on the incidence of new ischemic lesion after embolic stroke of undetermined source.

Changes in brain microstructure during infancy and childhood using clinical feasible ADC-maps.

Abstract: The purpose of this study was to examine age-related changes in apparent diffusion coefficient (ADC) during infancy and childhood using routine MRI data. A total of 112 investigations of patients aged 0 to 17.2 years showing a normal degree of myelination and no signal abnormalities on conventional MRI were retrospectively selected from our pool of pediatric MRI examinations at 1.5T. ADC maps based on our routinely included axial diffusion weighted sequence were created from the scanner. ADC values were measured in 35 different brain regions investigating normal age-related changes during the maturation of the human brain in infancy and childhood using clinical feasible sequences at 1.5T. The relationship between ADC values and age in infancy and childhood can be described as an exponential function. With increasing age, the ADC values decrease significantly in all brain regions, especially during the first 2 years of life. Except in the peritrigonal white matter, no significant differences were found between both hemispheres. Between 0 and 2 years of life, no significant gender differences were detected. Using ADC maps based on a routinely performed axial diffusion weighted sequence, it was possible first to describe the relationship between ADC values and age in infancy and childhood as exponential function in the whole brain and second to determine normative age-related ADC values in multiple brain regions.

Changes of brain metabolite concentrations during maturation in different brain regions measured by chemical shift imaging

Abstract: We examined the effect of maturation on the regional distribution of brain metabolite concentrations using multivoxel chemical shift imaging. From our pool of pediatric MRI examinations, we retrospectively selected patients showing a normal cerebral MRI scan or no pathologic signal abnormalities at the level of the two-dimensional 1H MRS-CSI sequence and an age-appropriate global neurological development, except for focal neurological deficits. Seventy-one patients (4.5 months–20 years) were identified. Using LC Model, spectra were evaluated from voxels in the white matter, caudate head, and corpus callosum. The concentration of total N-acetylaspartate increased in all regions during infancy and childhood except in the right caudate head where it remained constant. The concentration of total creatine decreased in the caudate nucleus and splenium and minimally in the frontal white matter and genu. It remained largely constant in the parietal white matter. The concentration of choline-containing compounds had the tendency to decrease in all regions except in the parietal white matter where it remained constant. The concentration of myoinositol decreased slightly in the splenium and right frontal white matter, remained constant on the left side and in the caudate nucleus, and rose slightly in the parietal white matter and genu. CSI determined metabolite concentrations in multiple cerebral regions during routine MRI. The obtained data will be helpful in future pediatric CSI measurements deciding whether the ratios of the main metabolites are within the range of normal values or have to be considered as probably pathologic.