دورية أكاديمية
Rationale and design of the EU-CERT-ICD prospective study: comparative effectiveness of prophylactic ICD implantation
| العنوان: | Rationale and design of the EU-CERT-ICD prospective study: comparative effectiveness of prophylactic ICD implantation |
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| المؤلفون: | Zabel, M, Sticherling, C, Willems, R, Lubinski, A, Bauer, A, Bergau, L, Braunschweig, F, Brugada, J, Brusich, S, Conen, D, Cygankiewicz, I, Flevari, P, Taborsky, M, Hansen, J, Hasenfuß, G, Hatala, R, Huikuri, HV, Iovev, S, Kääb, S, Kaliska, G, Kasprzak, JD, Lüthje, L, Malik, M, Novotny, T, Pavlović, N, Schmidt, G, Shalganov, T, Sritharan, R, Schlögl, S, Szavits Nossan, J, Traykov, V, Tuinenburg, AE, Velchev, V, Vos, MA, Willich, SN, Friede, T, Svendsen, JH, Merkely, B, EU-CERT-ICD Study Investigators |
| المساهمون: | St George's Hospital Medical School |
| المصدر: | 193 ; 182 |
| بيانات النشر: | Wiley Open Access |
| سنة النشر: | 2018 |
| المجموعة: | Imperial College London: Spiral |
| مصطلحات موضوعية: | Science & Technology, Life Sciences & Biomedicine, Cardiac & Cardiovascular Systems, Cardiovascular System & Cardiology, Implantable cardioverter defibrillator, Risk factors, Mortality, Sudden cardiac death, CARDIOVERTER-DEFIBRILLATOR THERAPY, SEATTLE HEART-FAILURE, PRIMARY PREVENTION, RISK STRATIFICATION, MYOCARDIAL-INFARCTION, APPROPRIATE SHOCKS, PROPORTIONAL RISK, EJECTION FRACTION, SEX-DIFFERENCES, Cardiomyopathy, Dilated, Death, Sudden, Cardiac, Defibrillators, Implantable, Electrocardiography, Europe, Follow-Up Studies, Humans, Patient Selection, Prospective Studies |
| جغرافية الموضوع: | England |
| الوصف: | AIMS: The clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD) aims to assess its current clinical value. METHODS AND RESULTS: The EU-CERT-ICD is a prospective investigator-initiated non-randomized, controlled, multicentre observational cohort study performed in 44 centres across 15 European Union countries. We will recruit 2250 patients with ischaemic or dilated cardiomyopathy and a guideline indication for primary prophylactic ICD implantation. This sample will include 1500 patients at their first ICD implantation and 750 patients who did not receive a primary prevention ICD despite having an indication for it (non-randomized control group). The primary endpoint is all-cause mortality; the co-primary endpoint in ICD patients is time to first appropriate shock. Secondary endpoints include sudden cardiac death, first inappropriate shock, any ICD shock, arrhythmogenic syncope, revision procedures, quality of life, and cost-effectiveness. At baseline (and prior to ICD implantation if applicable), all patients undergo 12-lead electrocardiogram (ECG) and Holter ECG analysis using multiple advanced methods for risk stratification as well as detailed documentation of clinical characteristics and laboratory values. Genetic biobanking is also organized. As of August 2018, baseline data of 2265 patients are complete. All subjects will be followed for up to 4.5 years. CONCLUSIONS: The EU-CERT-ICD study will provide a necessary update about clinical effectiveness of primary prophylactic ICD implantation. This study also aims for improved risk stratification and patient selection using clinical and ECG risk markers. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 2055-5822 |
| العلاقة: | ESC Heart Failure; http://hdl.handle.net/10044/1/63984Test; https://doi.org/10.1002/ehf2.12367Test; PG/13/54/30358 |
| DOI: | 10.1002/ehf2.12367 |
| الإتاحة: | https://doi.org/10.1002/ehf2.12367Test http://hdl.handle.net/10044/1/63984Test |
| حقوق: | © 2018 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology. ESC HEART FAILURE ESC Heart Failure (2018) Published online in Wiley Online Library (wileyonlinelibrary.com) DOI:10.1002/ehf2.12367 This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribut ion in any medium, provided the original work is properly cited, the use is non-commercial and no modi fi cations or adaptations are made |
| رقم الانضمام: | edsbas.440069A6 |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 20555822 |
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| DOI: | 10.1002/ehf2.12367 |