This study was carried out in the stroke unit, Neurology department, Cairo University, in the period from May 2017 to October 2017. Patients were eligible for inclusion in the study if they were ≥ 18 years, had received the clinical diagnosis of acute ischemic stroke, and presenting within 24 h of symptom onset. Included patients were dichotomized into 2 groups: group I included patients who were eligible for thrombolysis and received IV rTPA and group II included patients who presented out of window or had one or more contraindication to IV rTPA administration. IV rTPA was administered according to the American Heart Association/American Stroke Association AHA/ASA guidelines for early management of acute ischemic stroke 2015 scientific statement [2].
The IV thrombolysis administered was alteplase (Actilyse) by Boehringer-Ingelheim, Germany.
Exclusion criteria were applied to the two groups for better matching between them.
Exclusion criteria: patients were excluded from the study if there was any past history of intracranial hemorrhage and known arteriovenous malformation, neoplasm, or aneurysm. They were also excluded if there was history of ischemic stroke or central nervous system surgery within the previous 3 months of stroke onset, gastrointestinal or urinary tract hemorrhage within 3 weeks of stroke onset or current use of an anticoagulant, and if the onset of stroke symptoms started beyond 24 h. According to the non-contrast CT scan of the brain, patients were excluded if there was evidence of intracranial hemorrhage or an established hypodensity occupying more than one-third of a hemisphere. Other exclusion criteria are if the blood pressure remained uncontrolled, systolic blood pressure > 185 mm Hg or diastolic blood pressure remains > 110 mm Hg despite repeated measurements, severe stroke as objectively measured by NIHSS > 25, glucose less than 50 mg/dl or more than 400 mg/dl, and platelet count below normal limit.
Patients were assessed clinically, at the time of presentation to the emergency department (ED) after stroke onset and at 1, 2, 24 h, and on days 7, 30, and 90. They were subjected to general, neurological examination and monitoring of vital signs.
The National Institute of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values indicating more severe neurologic impairment [3]. According to the NIHSS, strokes were categorized into mild NIHSS (≤ 8), moderate NIHSS [4,5,6,7,8,9,10], and severe stroke NIHSS (≥ 16). Included patients were assessed with NIHSS on admission and on day 7.
Clinical outcome of patients was assessed by the modified Rankin Scale (mRs) at 3 months. The modified Rankin Scale, a measure of disability. Scores on the modified Rankin Scale range from 0 (no symptoms at all) to 6 (death). Patients clinical outcome was categorized as favorable (score 0–2) or unfavorable (score 3–6) [11].
Patients were categorized according to stroke etiology based on Toast classification into 4 stroke categories: large-artery atherosclerosis, cardio-embolism, small-vessel occlusion (lacune), and “others” which included stroke of other determined etiology and stroke of undetermined etiology [12]. Based on the vascular territory distribution of stroke in brain imaging, patients were classified according to The Oxfordshire Community Stroke Project (OCSP) clinical classification of subtypes of cerebral infarction. OCSP includes total and partial anterior circulation infarction, lacunar infarction, and posterior circulation infarction. OCSP can be used to predict early mortality, functional outcome, and whether the infarct was due to a large- or small-vessel occlusion. The OCSP classification was originally developed and tested by neurologists as part of a community-based study of first-ever stroke [13].
The following laboratory investigations were performed: complete blood count, coagulation profile, blood sugar, renal functions, and electrolytes. Radiological investigations: non-contrast computed tomography (CT): it was done on a GE bright speed 16 scanner at the computed tomography unit, Emergency Department, Kasr AL Ainy Hospital, that is available 24 h every day. The main role of CT is to exclude intracerebral hemorrhage and stroke mimics. Magnetic resonance imaging (MRI): was not routinely done to all patients, and done only in cases where there was suspicion for the diagnosis of ischemic infarction, or in patients showing deterioration of the clinical condition without evident cause on CT brain. It was performed on a 1.5-T Phillips Intera® scanner at the Magnetic Resonance Unit, Radiology Department, Kasr AL Ainy Hospital. The following protocols were used: T1-weighted images (axial), T2-weighted images (axial), fluid-attenuated inversion recovery (FLAIR) (axial), diffusion-weighted images (DWI), and apparent diffusion coefficient (ADC). DWI and corresponding ADC maps are the most sensitive imaging modality in detection of brain infarction. It can detect infarction within minutes from onset. Its sensitivity is up to 73–92% in the first 3 h and up to 95–100% in the first 6 h [14]. All patients did the rest of the battery of investigations routinely done in the stroke unit, Neurology department, Cairo University, including extracranial and transcranial carotid and vertebro-basilar duplex added to echocardiography.
Statistical methods
Data were coded and entered with SPSS (Statistical Package for the Social Sciences) version 25, 2017. Mean, standard deviation, median, minimum, and maximum were used in quantitative data. Frequency and relative frequency were used for categorical data. Comparisons were done using the non-parametric Kruskal-Wallis and Mann-Whitney tests. The chi-square test was used for comparisons between categorical data. Correlations between quantitative variables were done by Spearman’s correlation coefficient. P values less than 0.05 were considered statistically significant.