![]() As of November 2018, the study has been approved by the ethics committees listed (the reference number of the ethics committee is given, if available, in brackets): Ethik-Kommission des Landes Berlin, Berlin, Germany (15/0299 - EK 11) Ethik-Kommission der Bayerischen Landesärztekammer (BLÄK), Munich, Germany (7/16155) Ethikkommission an der Medizinischen Fakultät Ernst-Moritz-Arndt-Universität Greifswald, Greifswald, Germany (bMPG 05/16) Ethik-Kommission bei der Landesärztekammer Baden-Württemberg, Stuttgart, Germany (B-MP-2015-005#A1) El Comité Ético de Investigación Clínica del Parc de Salut Mar (CEIC-Parc de Salut Mar), Madrid, Spain Den Videnskabsetiske Komité for Region Nordjylland, Aalborg, Denmark Ethics Committee for Clinical Research at Development Society of Pauls Stradins Clinical University Hospital, Riga, Lithuania (No 270116-3E) EC of the University hospital Olomouc, Olomouc, Czech Republic (21/16 MEK 7) Ethik-Kommission bei der Medizinischen Fakultät der Universität Würzburg, Wurzburg, Germany (161/15_mn) Ethikkommission der Landesärztekammer Thüringen, Jena, Germany (33541/2015/95) Ethik-Kommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität Münster, Munster, Germany Ethikkommission an der Medizinischen Fakultät der Universität Rostock, Rostock, Germany (CIV-15-02-013133) Ethikkommission der Fakultät für Medizin der Technischen Universität München, Munich, Germany (538/15 Mm) EC of IKEM and Thomayer hospital, Prague, Czech Republic (514/16 + 926/16) EC of the Ceske Budejovice hospital, Budejovice, Czech Republic (1/16) Ethisch Comité van het OLV Ziekenhuis Aalst, Aalst, Belgium (2016/040) Comité Medische Ethiek, Gent, Belgium (16/030 L) Egészségügyi Nyilvántartási és Képzési Központ (EEKH), Budapest, Hungary Fakultní nemocnice u sv. īefore any patient can be enrolled, the locally responsible ethics committee must have approved the study and the patient or their legal representative must have signed the informed consent form. In contrast, some larger trials involving monitoring of multiple biological measures have shown neutral results, while modifications in design can make a difference. ![]() The response was a simple, predefined titration scheme for guideline-recommended heart failure medication dosage which resulted in a significant decrease in hospitalizations due to heart failure. ![]() The recent CardioMEMS heart sensor allows monitoring of pressure to improve outcomes in NYHA class III heart failure patients (CHAMPION) trial involved continuous measurement of the pulmonary wedge pressure. Another key element for successful RM seems to be a simple and easily implementable response to the information obtained by RM. A rationalistic interpretation could be that monitoring is more promising in conditions that present with little or no symptoms, such as hyperglycemia and high blood pressure, whereas COPD exacerbations present quite acutely. RM results in better treatment control in patients with diabetes and hypertension, whereas this effect has been more difficult to prove in patients with COPD. In this paper, we describe the literature and rationale behind the design and interventions towards new-onset arrhythmias, as well as future perspectives and limitations for the use of ICMs. An estimated 1400 patients will be enrolled and followed until 372 primary endpoints have occurred. Physicians are provided with suggestions on how to respond to ICM-documented arrhythmias. The study will enroll and randomize a cohort of high-risk postmyocardial infarction patients with CHA 2DS 2-VASc score ≥ 4 and left ventricular ejection fraction > 35% to an ICM or conventional treatment. ![]() In addition, the study will allow us to describe the interplay between baseline characteristics, arrhythmias, and clinical events to improve the treatment of this high-risk patient population. The Biomonitoring in patients with preserved left ventricular function after diagnosed myocardial infarction (BIO-GUARD-MI) study is designed to investigate and clarify whether the incidence of major adverse cardiac events can be decreased by early detection and treatment of cardiac arrhythmias using an ICM in patients after myocardial infarction. Meine Inhalte subNavigationMarker subNavigationPointer.Mehr subNavigationMarker subNavigationPointer.■ Für Ärztinnen und Ärzte in Weiterbildung.Gebiete subNavigationMarker subNavigationPointer.
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