This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the U.S. Food and Drug Administration (FDA). The FDA established the Standardized Data Collection for Cardiovascular Trials Initiative in 2009 to simplify the design and conduct of clinical trials intended to support marketing applications. The writing committee recognizes that these definitions may be used in other types of clinical trials and clinical care processes where appropriate. Use of these definitions at the FDA has enhanced the ability to aggregate data within and across medical product development programs, conduct meta-analyses to evaluate cardiovascular safety, integrate data from multiple trials, and compare effectiveness of drugs and devices. Further study is needed to determine whether prospective data collection using these common definitions improves the design, conduct, and interpretability of the results of clinical trials.

Objective-Intraventricular extension of intracerebral hemorrhage (IVH) is an independent predictor of poor outcome. IVH volume may be important in outcome prediction and management; however, it is difficult to measure routinely.Design and Patients-We reviewed the charts and computed tomographies of a cohort of consecutive patients with IVH. The cohort was divided into two groups: index and validation by random sampling. IVH and intracerebral hemorrhage (ICH) volume were measured manually in all patients. IVH was also graded using a simple classification system termed IVH score (IVHS). Clinical outcome was determined by the modified Rankin Scale (mRS) at discharge and in-hospital death. Poor outcome was defined as mRS 4-6.Main Results-One hundred seventy-five patients were analyzed, 92 in the index group and 83 in the validation group. Exponential regression yielded the following formula for estimating IVH volume (mL): eÎVHS/5 (R 2 = .75, p < 0.001). The IVH estimation formula was then verified in the validation group (R 2 = .8, p < 0.001). The following correlations with mRS were obtained: IVH volume R = .305; ICH volume R = .468; total volume [TV] R = .571 (p < 0.001 for all three correlations). Partial correlation of TV with mRS controlling for ICH volume yielded R = .3 for TV (p < 0.001). Logistic regression model comparing ICH and TV association with poor outcome yielded the following: ICH odds ratio = 5.2, 95% confidence interval 2.3-11.6, p < 0.001; TV odds ratio = 41.6, 95% confidence interval 9.6-180.6, p < 0.001. Substituting TV for ICH volume in the ICH score resulted in a significant increase in the specificity from 64% to 87% for predicting mortality. (7) is a known independent predictor of poor outcome (1,(7)(8)(9)(10)(11)(12)(13)(14) and several studies have demonstrated a direct relation between IVH volume and poor outcome or mortality (20,25,26). Yet, most studies investigating IVH volume use sophisticated and time-consuming volumetric analyses (15) that are impractical for routine clinical use and clinicians still lack a method for easily obtaining an estimate of the IVH volume. The purpose of this study was to create a useful tool for rapid determination of IVH volume and to further explore the prognostic significance of IVH volume. Specifically, we tried to assess the relationship between IVH volume or total volume (TV the combination of ICH and IVH volume) and clinical outcome. Conclusions-IVHS METHODS Study Design and PopulationA retrospective chart review of all patients admitted to our stroke center between April 2003 and June 2006 with the diagnosis of ICH. Patients were included if they suffered from spontaneous nontraumatic ICH and had evidence of IVH on computed tomography (CT) during admission done within 24 hours of onset. Patients were excluded from the analysis if they had ICH secondary to vascular malformations, tumor, or hemorrhagic conversion of an infarct. All CT scans were done using identical technique (slice thickness 5 mm, gantry tilt −16). We also excluded patient...

Vascular cognitive impairment (VCI) is the second most prevalent type of dementia in the world. The white matter damage that characterizes the common subcortical ischemic form of VCI can be modeled by ligating both common carotid arteries in the Wistar rat to induce protracted cerebral hypoperfusion. In this model, we find that repetitive intranasal administration of recombinant E-selectin to induce mucosal tolerance and to target immunomodulation to activating blood vessels potently suppresses both white matter (and possibly gray matter) damage and markers of vessel activation (tumor necrosis factor and E-selectin); it also preserves behavioral function in T-maze spontaneous alternation, T-maze spatial discrimination memory retention, and object recognition tests. Immunomodulation may be an effective novel strategy to prevent progression of VCI.

Evidence that inflammatory and immune mechanisms may have a critical role in the development of vasospasm after subarachnoid hemorrhage is accumulating. We examined, therefore, whether induction of immunological tolerance to the adhesion molecule that is uniquely expressed on activated endothelium, E-selectin, could inhibit the vasospasm provoked by subarachnoid blood in a rat subarachnoid hemorrhage model. We found that intranasal instillation of E-selectin every other day for 10 days on a mucosal tolerization schedule suppressed delayed type hypersensitivity to Eselectin confirming tolerance to that molecule and markedly suppressed basilar artery spasm after subarachnoid hemorrhage. The results of this proof-of-concept study suggest that agents that can mimic the local effects of the mediators of mucosal tolerance could have therapeutic potential for the management of post-subarachnoid hemorrhage vasospasm.