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During the past 10 years, the health of people in Eastern Europe and the former Soviet Union has undergone changes very different from the health patterns seen in their Western counterparts. Mortality from cardiovascular disease has been decreasing continuously in the USA and many Western European countries, but it has increased or remained unchanged in many of the states of Eastern Europe. Analysis of this phenomenon has been hindered by insufficient information. The International Registry of Acute Coronary Syndromes registry study in Transitional Countries ISACS-TC is both a retrospective—over a 1-year period—and prospective study which was designed in order to obtain data of patients with acute coronary syndromes ACSs in countries with economy in transition in Central and Eastern Europe, and herewith control and optimize internationally guideline recommended therapies in these countries. The registry encourages optimal individualization of evidence-based therapies and the international patient body ensures good representation of multiple practice patterns. It may help to make an additional improvement in clinical outcomes of countries with economy in transition. The collapse of the Berlin Wall brought with it massive economic, social, and political changes for the countries that emerged from the Socialist era. Currently, the predominant share of the global burden of cardiovascular disease CVD is concentrated in these countries. Extremely limited data are available about the mortality rates of acute CVD in Central and Eastern European countries, 2—4 although the available data suggest higher proportion of in-hospital mortality deaths attributed to CVD in these countries when compared with the European member states. Because changes in the economic context of most countries come very quickly and often bring strict consequences, reforms in clinical practice are particularly challenging in one of the most complex areas of CVD: the acute coronary syndromes ACS. In terms of pathophysiology, ACSs share common underlying mechanisms, being almost always associated with rupture of an atherosclerotic plaque and partial or complete thrombosis of the related coronary artery. A very narrow interpretation would be that only patients similar to those enrolled in the trial would receive benefit. The controversy over the high bleeding risk of dual antiplatelet therapy is less over the validity of the findings in the subjects randomized than over whether those findings can be generalized to other groups of patients. Accordingly, there are no randomized trials that have specifically evaluated the use of combined clopidogrel and aspirin in patients with STEMI undergoing primary percutaneous coronary intervention. Differences in drugs' efficacy and side effects make comparison of dual antiplatelet therapy particularly relevant for care of these patients, as they are at high risk for death, and anticoagulants carry a significant increase in bleeding risk. Translation of the extensive information built up from randomized controlled trials into routine clinical practice is incessantly warranted. Our view is that observational registry databases can and should play an important role in the evaluation of therapy. By design, a registry database is relatively non-selective, so that the entire spectrum of patients with disease is represented. In some conditions, registries may be preferable designs for studies of effectiveness, that is, whether a drug, device, or procedure in fact achieves its desired effect in the real world. Many patients included in a clinical database would not be included in a randomized trial. Half the randomized patients were assigned to surgery and half to the medical group. Survival in the medically randomized and non-randomized patient groups was similar in the estimates at 5-year follow-up. A number of key distinguishing observational studies have been published from the registry of the Coronary Artery Surgery Study that have considerably enhanced the value of the overall investigation, including examinations of the efficacy of coronary bypass surgery in the elderly, 9 those with poor left ventricular function, 10 and those with severe angina. A variety of factors, including national healthcare reform, austerity measures, stringent regulation, and a variety of cost issues related to specific geographical conditions, may significantly slow the use of technologies and drugs. In this socioeconomic context, non-randomized comparisons either are sufficient to address the research question or, in some cases, may be necessary because of the following issues with randomized treatment. Can providers ethically introduce randomization between relatively new vs. How can compliance and adherence to a treatment be studied, if not by observing what people benefit in real-world situations? The ISACS Advisory Committee has identified five roles to promote health and prevent mortality from ischaemic heart disease in older adults: i to provide high-quality health information to public health professionals and consumers; ii to support healthcare organizations in prevention efforts; iii to integrate public health prevention expertise with a cardiology services network; iv to identify and implement effective prevention efforts; and v to monitor changes related to medications and coronary procedures in the health of older adults. The International Registry of Acute Coronary Syndromes registry study in Transitional Countries ISACS-TC is both a retrospective—over a 1-year period—and prospective study which was designed in order to obtain data of patients with ACSs, and herewith control and optimize internationally guideline recommended therapies in these countries with economy in transition. The registry encourages optimal individualization of evidence-based therapies, and the international patient body ensures good representation of multiple practice patterns. Adhesion to the project was given by collaborative centres in 18 countries with economy in transition Table 1. Four countries Bosnia and Herzegovina, Montenegro, Romania, and Serbia have recruited relatively more study hospitals than other countries to provide a more descriptive overview of national practices in the management and outcomes of patients with ACS. Examples of patient-reported data include health-related quality of life and symptoms. Examples of clinician-reported data include clinical diagnoses, clinical signs, laboratory results, medications, cardiac procedures, and biological specimens. Secondary Centre: healthcare services offered by medical specialists it includes acute coronary unit with or without cardiac catheterization laboratory. Alert for any source of bias is important, and the value of a registry is enhanced by its ability to provide a formal assessment of the likely magnitude of all potential sources of bias. Each collaborating centre of each country area served as a coordinating and data entry centre for the study first level. Metropolitan hospitals under the responsibility of the Principal Investigator of the country formed the intermediate monitoring teams second level. After any possible errors in case registration were corrected, the final data collection of every patient was sent to the international coordinating centre. In addition, several approaches were used to facilitate quality control and standardization of medical records in a systematic manner. First, national Principal Investigators and physicians responsible of the collaborating centres met twice a year to discuss technical and administrative issues of the study. Secondly, site visits were made by the national Principal Investigator staff to collaborating centres reporting technical difficulties or having problems with compliance. Thirdly, to ensure uniformity in the coding of cardiovascular events between the collaborating centres, quality control tests were held at regular intervals usually once every 6 months. ISACS-TC is a large international investigative effort that will evaluate the role of evidence-based therapies and interventional cardiac procedures over a 5-year period. Stradins Clinical University Hospital. Google Scholar. Oxford University Press is a department of the University of Oxford. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide. Sign In or Create an Account. Sign in through your institution. ESC Publications. Advanced Search. Search Menu. Article Navigation. Close mobile search navigation Article Navigation. Volume Article Contents Abstract. Focus on acute coronary syndromes. From controlled randomized trials into routine clinical practice. Role of observational databases in evaluating therapy. One strategy does not fit all. Participating centres and sampling methods. Assessing the magnitude of bias. Journal Article. Email: raffaele. Oxford Academic. Lina Badimon. Olivia Manfrini. Sergei Boytsov. Irfan Daullxhiu. Mirza Dilic. Maria Dorobantu. Andreis Erglis. Valery Gafarov , Valery Gafarov. Christopher P. Eva Goncalvesova. Asen Goudev. Olivja Gustiene. Alistair Hall. Irena Karpova. Sasko Kedev. Nicolay Manak. Miograd Ostojic. Alexander N. Mihail Popovici. Martin Studenkan. Kalman Toth. Zorana Vasiljevic. Ilja Zakke. Remigijus Zaliunas. Raffaele Bugiardini. Viola Vaccarino. Dijana Trninic. Assen Goudev. Davor Milicic. Andrejs Erglis. Remigius Zaliunas. Olivija Gustiene. Bozidarka Knezevic. Valery Gafarov. Maria Dorubantu. Miodrag Ojstoic. Martin Studencan. Alexander N Parkhomenko. Christopher Gale. Nicoly Manak. Milica Lovric. Dragana Mandic. Elina Trendafilova. Desislava Somleva. Ljiljana Krivokapic. Gordana Rajovic. Mirko Saranovic. Colovic Radoman. Slavica Cvijovic Tomic. Vujica Ljubic. Milan Velickovic. Sonja Radojicic. Catalina Arsenescu-Georfescu. Smaranda Garbea. Capalneanu Radu. Dan Olinic. Pop Calin. Alexandru Chifor. Katalin Babes. Dan Dominic lonescu. Elvira Craiu. Hie Petrescu. Ionescu Magda. Serban Luminita. Imre Benedek. Sorin Marinescu. Nanea Tiberiu. Gabriela Gheorghe. Ion Malaescu. Nicolae Trocan. Dimulescu Doina. Cezar Macarie. Biljana Putnikovic. Aleksandra Arandjelovic. Natasa Markovic Nikolic. Marija Zdravkovic. Jelena Saric. Slavica Radovanovic. Irena Matic. Nebojsad Srbljak. Goran Davidovic. Stefan Simovic. Sinisa Zivkovic. Slavenka Petkovic-Curic. Select Format Select format. Permissions Icon Permissions. Abstract During the past 10 years, the health of people in Eastern Europe and the former Soviet Union has undergone changes very different from the health patterns seen in their Western counterparts. Acute coronary syndrome , Evidence-based secondary prevention therapy , Cardiac catheterization and procedures. Table 1 Open in new tab. Hospitals type. Global and regional mortality from causes of death for 20 age groups in and a systematic analysis for the global burden of disease study Google Scholar Crossref. Search ADS. In-hospital case fatality rates for acute myocardial infarction in Romania. Atherothrombosis: a widespread disease with unpredictable and life-threatening consequences. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. Addition of clopidogrel to aspirin in 45, patients with acute myocardial infarction: randomised placebo-controlled trial. A randomized trial of coronary artery bypass surgery. Comparability of entry characteristics and survival in randomized patients and nonrandomized patients meeting randomization criteria. Comparison of coronary artery bypass surgery and medical therapy in patients 65 years of age or older. Results of coronary artery surgery in patients with poor left ventricular function CASS. Survival following coronary artery bypass grafting in patients with severe angina pectoris CASS. Google Scholar PubMed. ACSN accessed 2 October Bridging the gender gap: Insights from a contemporary analysis of sex-related differences in the treatment and outcomes of patients with acute coronary syndromes. Published on behalf of the European Society of Cardiology. All rights reserved. For permissions please email: journals. Issue Section:. Download all slides. Views 2, More metrics information. Total Views 2, Email alerts Article activity alert. Advance article alerts. New issue alert. Receive exclusive offers and updates from Oxford Academic. Clinical profile of patients with no-reperfusion therapy in Bosnia and Herzegovina and Serbia. Gender differences in case fatality rates of acute myocardial infarction in Serbia. Perspectives of cardiovascular research in Central and Eastern Europe letter. Related articles in PubMed Natriuretic peptides and soluble ST2 improves echocardiographic diagnosis of elevated left ventricular filling pressures. Usefulness of the SARC-F questionnaire and the measurement of the hand grip strength in predicting short-term mortality in older patients hospitalized for acute heart failure. Intrapopulation germinability may help the Mediterranean plant species Poterium spinosum L. Citing articles via Web of Science Atrial fibrillation rhythm management: a matter of timing. Social drivers in atrial fibrillation occurrence, screening, treatment, and outcomes: systematic-narrative hybrid review. Early detection of atrial fibrillation in the digital era, risk factors, treatment options, and the need for new definitions. Genetics, transcriptomics, metagenomics, and metabolomics in the pathogenesis and prediction of atrial fibrillation. More from Oxford Academic. Cardiovascular Medicine. Clinical Medicine. Medicine and Health. Authoring Open access Purchasing Institutional account management Rights and permissions. Get help with access Accessibility Contact us Advertising Media enquiries.

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