Background: Chronic antiplatelet therapy in the post-acute phase of non-cardioembolic ischemic stroke is limited by the risk of intracranial hemorrhage (ICH) complications. Methods: We developed an ICH risk score based on the PERFORM trial cohort (n = 19,100), which included patients with a non-cardioembolic ischemic stroke or transient ischemic attack, and externally validated this score in one contemporary trial of very similar size and inclusion criteria, the PRoFESS trial (n = 20,332 patients). Outcome was ICH over 2 years. A Cox proportional-hazard regression analysis identified risk factors. Discrimination was quantified with c-statistics and calibration was assessed by comparing predicted and observed ICH risk in PERFORM and PRoFESS. Results: ICH occurred within 2 years in 263 (1.4%) patients in PERFORM trial and in 246 (1.2%) patients in PRoFESS trial. A 13-point score based on 9 items (Intracranial-B2LEED3S score - low body mass index, blood pressure, lacune, elderly, Asian ethnicity, coronary artery or cerebrovascular disease history, dual antithrombotic agent or oral anticoagulant, gender) was derived from the PERFORM trial. In PERFORM, the observed 2-year ICH risk varied from 0.75% in low-risk (score ≤2) to 2.44% in high-risk patients (score ≥5) with an acceptable calibration but a low discrimination both in PERFORM (c-statistic 0.64, 95% CI 0.61-0.68) and on external validation in PRoFESS (0.58, 95% CI 0.55-0.62). Conclusion: The Intracranial-B2LEED3S score helps identify patients who are at a high risk of bleeding. However, other variables need to be identified to improve the score (e.g., microbleeds) (Clinical Trial Registration Information ISRCTN66157730). URL: http://www.isrctn.com/ISRCTN66157730?totalResults=5&pageSize=10&page=1&searchType=basic-search&offset=3&q=&filters=conditionCategory%3ACirculatory+System%2CrecruitmentCountry%3ATaiwan%2CrecruitmentCountry%3AAustria&sort=.

Background: Measurement of far wall common carotid artery intima-media thickness (CCAIMT) has emerged as a predictor of incident cardiovascular events. The Cardiovascular Risk Factor Multiple Evaluation in Latin America (CARMELA) study was the first large-scale population-based assessment of both CCAIMT and cardiovascular risk factor prevalence in 7 Latin American cities; the relationship between CCAIMT and cardiovascular risk markers was assessed in these urban Latin American centers. Methods: CARMELA was across-sectional, population-based, observational study using stratified, multistage sampling. The participants completed a questionnaire, were evaluated in a clinical visit and underwent carotid ultrasonography. Clinical measurements were obtained by health personnel trained, certified and supervised by CARMELA investigators. Mannheim intima-media thickness consensus guidelines were followed for measurement of CCAIMT. Results: In all cities and for both sexes, CCAIMT increased with higher age. CCAIMT was greater in the presence of cardiovascular risk factors than in their absence. In all cities, there was a statistically significant linear trend between increasing CCAIMT and a growing number of cardiovascular risk factors (p < 0.001). After adjustment for age and sex, metabolic syndrome was strongly associated with increased CCAIMT (p < 0.001 in all cities), as were hypercholesterolemia, obesity and diabetes (p < 0.001 in most cities). By multivariate analysis, hypertension was independently associated with an increase in CCAIMT in all cities (p < 0.01). Conclusions: CARMELA was the first large-scale population study to provide normal CCAIMT values according to age and sex in urban Latin American populations and to show CCAIMT increases in the presence of cardiovascular risk factors and metabolic syndrome.

Background: Measurement of far wall common carotid artery intima-media thickness (CCAIMT) has emerged as a predictor of incident cardiovascular events. The Cardiovascular Risk Factor Multiple Evaluation in Latin America (CARMELA) study was the first large-scale population-based assessment of both CCAIMT and cardiovascular risk factor prevalence in 7 Latin American cities; the relationship between CCAIMT and cardiovascular risk markers was assessed in these urban Latin American centers. Methods: CARMELA was across-sectional, population-based, observational study using stratified, multistage sampling. The participants completed a questionnaire, were evaluated in a clinical visit and underwent carotid ultrasonography. Clinical measurements were obtained by health personnel trained, certified and supervised by CARMELA investigators. Mannheim intima-media thickness consensus guidelines were followed for measurement of CCAIMT. Results: In all cities and for both sexes, CCAIMT increased with higher age. CCAIMT was greater in the presence of cardiovascular risk factors than in their absence. In all cities, there was a statistically significant linear trend between increasing CCAIMT and a growing number of cardiovascular risk factors (p < 0.001). After adjustment for age and sex, metabolic syndrome was strongly associated with increased CCAIMT (p < 0.001 in all cities), as were hypercholesterolemia, obesity and diabetes (p < 0.001 in most cities). By multivariate analysis, hypertension was independently associated with an increase in CCAIMT in all cities (p < 0.01). Conclusions: CARMELA was the first large-scale population study to provide normal CCAIMT values according to age and sex in urban Latin American populations and to show CCAIMT increases in the presence of cardiovascular risk factors and metabolic syndrome.