دورية أكاديمية

Rationale and design of the EU‐CERT‐ICD prospective study:comparative effectiveness of prophylactic ICD implantation

التفاصيل البيبلوغرافية
العنوان: Rationale and design of the EU‐CERT‐ICD prospective study:comparative effectiveness of prophylactic ICD implantation
المؤلفون: Zabel, M. (Markus), Sticherling, C. (Christian), Willems, R. (Rik), Lubinski, A. (Andrzej), Bauer, A. (Axel), Bergau, L. (Leonard), Braunschweig, F. (Frieder), Brugada, J. (Josep), Brusich, S. (Sandro), Conen, D. (David), Cygankiewicz, I. (Iwona), Flevari, P. (Panagiota), Taborsky, M. (Milos), Hansen, J. (Jim), Hasenfuss, G. (Gerd), Hatala, R. (Robert), Huikuri, H. V. (Heikki V.), Iovev, S. (Svetoslav), Kaeaeb, S. (Stefan), Kaliska, G. (Gabriela), Kasprzak, J. D. (Jaroslaw D.), Luethje, L. (Lars), Malik, M. (Marek), Novotny, T. (Tomas), Pavlovic, N. (Nikola), Schmidt, G. (Georg), Shalganov, T. (Tchavdar), Sritharan, R. (Rajeeva), Schloegl, S. (Simon), Nossan, J. S. (Janko Szavits), Traykov, V. (Vassil), Tuinenburg, A. E. (Anton E.), Velchev, V. (Vasil), Vos, M. A. (Marc A.), Willich, S. N. (Stefan N.), Friede, T. (Tim), Svendsen, J. H. (Jesper Hastrup), Merkely, B. (Bela), Seegers, J. (J.), Munoz-Exposito, P. (P.), Tichelbacker, T. (T.), Kirovo, A. (A.), Sritharan, R. (R.), Joerss, K. (K.), Macken, J. (J.), Misdaq, M. (M.), Rudolph, K. (K.), Schmidt, G. (G.), Mueller, A. (A.), Dommasch, M. (M.), Sinnecker, D. (D.), Sinner, M. (M.), Bauer, A. (A.), Dissmann, R. (R.), Burmester, U. (U.), Behrens, S. (S.), Gregor, M. (M.), Stefanow, S. (S.), Rueb, N. (N.), Wolpert, C. (C.), Bimmel, D. (D.), Lieberz, C. (C.), Maier, L. (L.), Schwinger, R. (R.), Blaschke, F. (F.), Pieske, B. (B.), Groenefeld, G. (G.), Klein, G. (G.), Gardiwal, A. (A.), Merkely, B. (B.), Szeplaki, G. (G.), Perge, P. (P.), Nossan, J. S. (J. Szavits), Rotkvic, L. (L.), Pavlovic, N. (N.), Manola, S. (S.), Vinter, O. (O.), Benko, I. (I.), Brusic, S. (S.), Avdovic, E. (E.), Klasan, M. (M.), Bakotic, Z. (Z.), Anic, A. (A.), Lubinski, A. (A.), Kowalczyk, E. (E.), Kucejko, T. (T.), Czechowska, A. (A.), Wybor, K. (K.), Cygankiewicz, I. (I.), Ptaszynski, P. (P.), Kasprzak, J. (J.), Qavoq, H. (H.), Guzik, P. (P.), Krauze, T. (T.), Sterlinski, M. (M.), Hatala, R. (R.), Svetlosak, M. (M.), Kaliska, G. (G.), Martinek, J. (J.), Thamsborg, K. (K.), Hansen, J. (J.), Schloett-Hyldelund, I. M. (I. M.), Laage-Petersen, J. (J.), Willems, R. (R.), Vandenberk, B. (B.), van Soest, S. (S.), Traykov, V. (V.), Iovev, S. (S.), Shalganov, T. (T.), Sticherling, C. (C.), Conen, D. (D.), Giesebart, S. (S.), Novotny, T. (T.), Kozak, M. (M.), Taborsky, M. (M.), Galuszka, J. (J.), Tuinenburg, A. E. (A. E.), Wijers, S. (S.), Dunnink, A. (A.), Sprenkeler, D. (D.), Brugada, J. (J.), Arbelo, E. (E.), Trucco, E. (E.), Vidorreta, S. (S.), Huikuri, H. (H.), Kentta, T. (T.), Pelli, A. (A.), Huikuri, P. (P.), Koski, P. (P.), Braunschweig, F. (F.), Karlsson, H. (H.), Ersgaard, D. (D.), Platonov, P. (P.), Klingenheben, T. (T.), Scharfe, M. (M.), Reinhold, T. (T.), Cree, M. (M.), Hnatkova, K. (K.), Gerhardt, J. (J.), Rizas, K. (K.), Hamm, W. (W.), Roever, C. (C.), Harden, M. (M.), Kessel, B. (B.), Berg, A. (A.), Apel, S. (S.), Walker, F. (F.), Kirchhof, N. (N.), Goerlitz, A. (A.), Molitor, A. (A.), Heinrich, J. (J.), Annetzberger, S. (S.), Fuchs, B. (B.), Landwehr, A. (A.), Merk, A. (A.), Wilke, A. (A.), Hennecke, C. (C.), Mansch, R. (R.)
بيانات النشر: John Wiley & Sons
سنة النشر: 2019
المجموعة: Jultika - University of Oulu repository / Oulun yliopiston julkaisuarkisto
مصطلحات موضوعية: Implantable cardioverter defibrillator, Mortality, Risk factors, Sudden cardiac death
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
وصف الملف: application/pdf
اللغة: English
العلاقة: info:eu-repo/grantAgreement/EC/FP7/602299/EU/Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in EUrope/EU-CERT-ICD
الإتاحة: http://urn.fi/urn:nbn:fi-fe2020042822783Test
حقوق: info:eu-repo/semantics/openAccess ; © 2018 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. ; https://creativecommons.org/licenses/by-nc-nd/4.0Test/
رقم الانضمام: edsbas.E7D6A51A
قاعدة البيانات: BASE