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Randomized trials in cardiology

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https://www.readbyqxmd.com/read/28545514/a-coordinated-pcp-cardiologist-telemedicine-model-pctm-in-china-s-community-hypertension-care-study-protocol-for-a-randomized-controlled-trial
#1
Lei Xu, Wei-Yi Fang, Fu Zhu, Hong-Guang Zhang, Kai Liu
BACKGROUND: Hypertension is a major risk factor for cardiovascular disease, and its control rate has remained low worldwide. Studies have found that telemonitoring blood pressure (BP) helped control hypertension in randomized controlled trials. However, little is known about its effect in a structured primary care model in which primary care physicians (PCPs) are partnering with cardiology specialists in electronic healthcare data sharing and medical interventions. This study aims to identify the effects of a coordinated PCP-cardiologist model that applies telemedicine tools to facilitate community hypertension control in China...
May 25, 2017: Trials
https://www.readbyqxmd.com/read/28526014/the-use-of-lipid-lowering-therapy-and-effects-of-antihyperglycaemic-therapy-on-lipids-in-subjects-with-type-2-diabetes-with-or-without-cardiovascular-disease-a-pooled-analysis-of-data-from-eleven-randomized-trials-with-insulin-glargine-100%C3%A2-u-ml
#2
Markolf Hanefeld, Louise Traylor, Ling Gao, Wolfgang Landgraf
BACKGROUND: Dyslipidaemia is a major contributor to the increased risk of cardiovascular disease (CVD) associated with type 2 diabetes (T2D). This study aimed to characterize the extent of lipid-lowering therapy use and its impact on lipid and glycaemic outcomes in people with T2D uncontrolled on oral agents who were enrolled in insulin glargine 100 units/mL (Gla-100) randomized controlled trials (RCTs). METHODS: A post hoc patient-level pooled analysis of eleven RCTs (≥24 weeks' duration) comparing Gla-100 (±oral antidiabetes drugs [OADs]) with OADs alone in people with T2D was performed...
May 19, 2017: Cardiovascular Diabetology
https://www.readbyqxmd.com/read/28523635/2017-position-paper-of-the-italian-society-for-cardiovascular-prevention-siprec-for-an-updated-clinical-management-of-hypercholesterolemia-and-cardiovascular-risk-executive-document
#3
Massimo Volpe, Roberto Volpe, Giovanna Gallo, Vivianne Presta, Giuliano Tocci, Emanuela Folco, Andrea Peracino, Elena Tremoli, Bruno Trimarco
The benefits achieved by implementing cardiovascular prevention strategies in terms of reduced incidence of atherosclerotic diseases and mortality are accepted, worldwide. In particular, the clinical management of hypercholesterolemia has a fundamental role for all preventive strategies, both in primary and secondary prevention, at each stage of cardiovascular risk. Since the net clinical benefit of lipid-lowering therapy largely depends on baseline individual cardiovascular risk profile, the assessment of individual risk is essential to establish type and intensity of both preventive and therapeutic strategies...
May 18, 2017: High Blood Pressure & Cardiovascular Prevention: the Official Journal of the Italian Society of Hypertension
https://www.readbyqxmd.com/read/28492084/prehospital-triage-of-patients-suffering-severe-dyspnoea-using-n-terminal-pro-brain-natriuretic-peptide-the-prebnp-trial-a-randomised-controlled-clinical-trial
#4
Morten T Bøtker, Maren T Jørgensen, Carsten Stengaard, Sophie-Charlott Seidenfaden, Mona Tarpgaard, Asger Granfeldt, Tanja Ø Mortensen, Thorbjørn Grøfte, Kristian D Friesgaard, Rikke Mærkedahl, Anette B Pedersen, Simon Lundorff, Troels Martin Hansen, Hans Kirkegaard, Erika F Christensen, Christian J Terkelsen
PURPOSE: The purpose of this study was to examine whether the addition of brain natriuretic peptide measurement to the routine diagnostic work-up by prehospital critical care team physicians improves triage in patients with severe dyspnoea. METHODS: Prehospital critical care team physicians randomly assigned patients older than 18 years with severe dyspnoea to routine diagnostic work-up or diagnostic work-up with incorporated point-of-care N-terminal pro-brain natriuretic peptide (NT-proBNP) measurement...
May 1, 2017: European Heart Journal. Acute Cardiovascular Care
https://www.readbyqxmd.com/read/28489217/intra-aortic-balloon-pump-in-cardiogenic-shock-state-of-the-art
#5
Petronio Generoso Thomaz, Leonel Adelino Moura, Giovana Muramoto, Renato Samy Assad
The clinical definition of cardiogenic shock is that of a low cardiac output and evidence of tissue hypoxia in the presence of adequate blood volume. Cardiogenic shock is the main cause of death related to acute myocardial infarction (AMI), with a mortality rate of 45-70% in the absence of aggressive and highly specialized technical care. The intra-aortic balloon pump (IABP) is one of the most widely used mechanical assisting devices. During the last two decades, about 42% of patients with AMI who evolved with cardiogenic shock received mechanical circulatory assistance with IABP...
January 2017: Revista do Colégio Brasileiro de Cirurgiões
https://www.readbyqxmd.com/read/28481893/evaluation-of-a-transdiagnostic-psychodynamic-online-intervention-to-support-return-to-work-a-randomized-controlled-trial
#6
Rüdiger Zwerenz, Jan Becker, Katharina Gerzymisch, Martin Siepmann, Martin Holme, Ulrich Kiwus, Sieglinde Spörl-Dönch, Manfred E Beutel
OBJECTIVES: Given their flexibility, online interventions may be useful as an outpatient treatment option to support vocational reintegration after inpatient rehabilitation. To that purpose we devised a transdiagnostic psychodynamic online intervention to facilitate return to work, focusing on interpersonal conflicts at the workplace often responsible for work-related stress. RESEARCH DESIGN AND METHODS: In a randomized controlled trial, we included employed patients from cardiologic, psychosomatic and orthopedic rehabilitation with work-related stress or need for support at intake to inpatient rehabilitation after they had given written consent to take part in the study...
2017: PloS One
https://www.readbyqxmd.com/read/28472974/benefit-of-dual-chamber-pacing-with-closed-loop-stimulation-in-tilt-induced-cardio-inhibitory-reflex-syncope-biosync-trial-study-protocol-for-a-randomized-controlled-trial
#7
Michele Brignole, Marco Tomaino, Arnaud Aerts, Fabrizio Ammirati, Félix Alejandro Ayala-Parades, Jean-Claude Deharo, Attilio Del Rosso, Mohamed H Hamdan, Maurizio Lunati, Angel Moya, Alessio Gargaro
BACKGROUND: The efficacy of dual-chamber cardiac pacing in neuro-mediated reflex syncope with a cardio-inhibitory response to the Tilt-Table test (TT) has not been definitively assessed so far. The lack of reproducibility of results from previous studies may be partially explained by discrepancies in subject selection and some weaknesses in design and methods. The European Society of Cardiology (ESC) has set a class IIb indication to pacemaker implantation in this population recommending further research...
May 4, 2017: Trials
https://www.readbyqxmd.com/read/28464769/adult-stem-cell-therapy-for-cardiac-repair-in-patients-after-acute-myocardial-infarction-leading-to-ischemic-heart-failure-an-overview-of-evidence-from-the-recent-clinical-trials
#8
Rygiel Katarzyna
Cardiovascular diseases (CVD) still represent the leading cause of mortality worldwide, despite the remarkable advances in interventional cardiology, cardiac surgery, and modern pharmacotherapy, particularly in the setting of acute myocardial infarction (AMI), chronic ischemic heart failure (HF), cardiomyopathy (CM), and the associated left ventricular (LV) dysfunction. A significant loss of cardiomyocytes that underlies all of these conditions was previously considered irreversible. However, current evidence indicates that the human heart has some potential for repair, and over the past decade, many research studies have been exploring the use of stem cells (SCs) to facilitate restoration of myocardium...
May 1, 2017: Current Cardiology Reviews
https://www.readbyqxmd.com/read/28462716/treatment-of-bifurcation-lesions-by-bail-out-tap-or-culotte-lost-in-translation
#9
Francesco Burzotta, Thierry Lefèvre, Jens Flensted Lassen, Niels Ramsing Holm, Goran Stankovic
BACKGROUND: Coronary bifurcated lesions (CBL) represent a hot topic of interventional cardiology. Provisional stenting, i.e. implantation of a drug-eluting (DES) in the main branch followed by side-branch (SB) intervention in case of suboptimal SB result, represents the gold standard to treat the vast majority of CBL undergoing percutaneous coronary interventions (PCI). The best technique for bail-out SB stenting has not been established. Prospective randomized trials comparing different stenting techniques may help provide important insights regarding the best way to conduct PCI in patients with CBL...
April 26, 2017: Reviews on Recent Clinical Trials
https://www.readbyqxmd.com/read/28460763/a-clinical-evaluation-of-the-xience-v-everolimus-eluting-stent-in-the-treatment-of-patients-with-coronary-artery-disease-result-from-thailand-registry-xience-v-performance-evaluation-thrive-study
#10
Songsak Kiatchoosakun, Pavit Pienvichit, Srun Kuanprasert, Navin Suraphakdee, Arintaya Phromminikul
OBJECTIVE: To evaluate the 2-year clinical outcomes of XIENCE(TM) V everolimus eluting stent (EES) for the treatment of coronary artery disease. BACKGROUND: Percutaneous coronary intervention with a drug eluting stent has become the preferred treatment in patients with coronary artery disease. Everolimus eluting stent had proven efficacy in randomized control trials but those trials may not represent daily practice of interventional cardiology. METHODS: The THRIVE study was a prospective, multicenter, real-world, single-arm registry...
March 2017: Indian Heart Journal
https://www.readbyqxmd.com/read/28454832/rationale-and-design-of-the-coronary-computed-tomographic-angiography-for-selective-cardiac-catheterization-relation-to-cardiovascular-outcomes-cost-effectiveness-and-quality-of-life-conserve-trial
#11
Sang-Eun Lee, Fay Y Lin, Yao Lu, Hyuk-Jae Chang, James K Min
Although coronary computed tomography angiography (CCTA) has shown promise as a "gatekeeper" to invasive coronary angiography (ICA) in longitudinal cohort studies, it remains unknown whether the strategy of selective ICA by initial performance of CCTA is either safe or effective when compared with a direct ICA strategy in patients with an American Heart Association (AHA)/American College of Cardiology (ACC) guideline-directed indication for ICA. OBJECTIVES: The CONSERVE trial is a prospective randomized multicenter trial to determine the clinical effectiveness of "selective catheterization" vs "direct catheterization" strategies for stable patients with suspected but without known coronary artery disease, who meet AHA/ACC guideline indication for ICA...
April 2017: American Heart Journal
https://www.readbyqxmd.com/read/28454829/design-and-rationale-of-the-compare-acute-trial-fractional-flow-reserve-guided-primary-multivessel-percutaneous-coronary-intervention-to-improve-guideline-indexed-actual-standard-of-care-for-treatment-of-st-elevation-myocardial-infarction-in-patients-with-multivessel
#12
Pieter C Smits, Amira Assaf, Gert Richardt, Elmir Omerovic, Mohamed Abdel-Wahab, Franz-Joseph Neumann
What the best strategy is for nonculprit lesions in ST-elevation myocardial infarction (STEMI) patients presenting with multivessel disease remains a clinical dilemma. Based on recent clinical studies suggesting that complete revascularization in the acute phase is beneficial, the European Society of Cardiology and American College of Cardiology/American Heart Association guidelines have been recently changed from class 3 discouragement to a class 2B recommendation concerning the treatment of the nonculprit lesions in the acute index procedure...
April 2017: American Heart Journal
https://www.readbyqxmd.com/read/28434948/international-and-multidisciplinary-expert-recommendations-for-the-use-of-biologics-in-systemic-lupus-erythematosus
#13
REVIEW
Jean-François Kleinmann, Florence Tubach, Véronique Le Guern, Alexis Mathian, Christophe Richez, David Saadoun, Karim Sacre, Jérémie Sellam, Raphaèle Seror, Zahir Amoura, Emmanuel Andres, Sylvain Audia, Brigitte Bader-Meunier, Gilles Blaison, Bernard Bonnotte, Patrice Cacoub, Sophie Caillard, Laurent Chiche, Olivier Chosidow, Nathalie Costedoat-Chalumeau, Claire Daien, Eric Daugas, Nairouz Derdèche, Andrea Doria, Olivier Fain, Fadi Fakhouri, Dominique Farge, Cem Gabay, Sylvie Guillo, Eric Hachulla, Najia Hajjaj-Hassouni, Mohamed Hamidou, Frédéric A Houssiau, Noémie Jourde-Chiche, Isabelle Koné-Paut, Aïcha Ladjouz-Rezig, Olivier Lambotte, Dan Lipsker, Xavier Mariette, Nicolas Martin-Silva, Thierry Martin, François Maurier, Roderich Meckenstock, Arsène Mékinian, Olivier Meyer, Shirine Mohamed, Jacques Morel, Bruno Moulin, Denis Mulleman, Thomas Papo, Vincent Poindron, Xavier Puéchal, Leonardo Punzi, Pierre Quartier, Laurent Sailler, Amar Smail, Martin Soubrier, Agnès Sparsa, Zoubida Tazi-Mezalek, Leith Zakraoui, Stéphane Zuily, Jean Sibilia, Jacques-Eric Gottenberg
BACKGROUND/PURPOSE: Despite conventional immunosuppressants, active and steroid-dependent systemic lupus erythematosus (SLE) represents a therapeutic challenge. Only one biologic, belimumab, has been approved, but other biologics are sometimes used off-label. Given the lack of evidence-based data in some clinical situations encountered in real life, we developed expert recommendations for the use of biologics for SLE. METHODS: The recommendations were developed by a formal consensus method...
April 18, 2017: Autoimmunity Reviews
https://www.readbyqxmd.com/read/28434933/assessing-the-eligibility-criteria-in-phase-iii-randomized-controlled-trials-of-drug-therapy-in-heart-failure-with-preserved-ejection-fraction-the-critical-play-off-between-a-pure-patient-phenotype-and-the-generalizability-of-trial-findings
#14
Hitesh C Patel, Carl Hayward, Jason Dungu, Sofia Papadopoulou, Abdel Saidmeerasah, Carlo Di Mario, Nesan Shanmugam, Martin R Cowie, Lisa J Anderson
AIMS: To investigate the effect of the different eligibility criteria used by phase III clinical studies in heart failure with preserved ejection fraction (HFpEF) on patient selection, phenotype and survival. METHODS AND RESULTS: We applied the key eligibility criteria of seven phase III HFpEF studies (DIG-Ancillary, CHARM-Preserved, PEP-CHF, I-PRESERVE, J-DHF, TOPCAT and PARAGON-HF [on-going]) to a typical and well-characterised HFpEF population (n=557) seen in modern European cardiological practice...
April 18, 2017: Journal of Cardiac Failure
https://www.readbyqxmd.com/read/28420661/person-centred-transition-programme-to-empower-adolescents-with-congenital-heart-disease-in-the-transition-to-adulthood-a-study-protocol-for-a-hybrid-randomised-controlled-trial-stepstones-project
#15
Mariela Acuña Mora, Carina Sparud-Lundin, Ewa-Lena Bratt, Philip Moons
INTRODUCTION: When a young person grows up, they evolve from an independent child to an empowered adult. If an individual has a chronic condition, this additional burden may hamper adequate development and independence. Transition programmes for young persons with chronic disorders aim to provide the necessary skills for self-management and participation in care. However, strong evidence on the effects of these interventions is lacking. Therefore, as part of the STEPSTONES project (Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS), we propose a trial to assess the effectiveness of a structured, person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood...
April 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28364270/safe-trial-an-ongoing-randomized-clinical-study-to-assess-the-role-of-cardiotoxicity-prevention-in-breast-cancer-patients-treated-with-anthracyclines-with-or-without-trastuzumab
#16
REVIEW
Icro Meattini, Giuseppe Curigliano, Francesca Terziani, Carlotta Becherini, Mario Airoldi, Giacomo Allegrini, Domenico Amoroso, Sandro Barni, Carmelo Bengala, Valentina Guarneri, Paolo Marchetti, Francesca Martella, Pierluigi Piovano, Agnese Vannini, Isacco Desideri, Roberto Tarquini, Giorgio Galanti, Giuseppe Barletta, Lorenzo Livi
Over the years, thanks to the addition of new generation systemic agents, as well as the use of more advanced and precise radiotherapy techniques, it was able to obtain a high curability rate for breast cancer. Anthracyclines play a key role in the treatment of breast disease, with a well-known benefit on disease-free survival of patients with positive nodal status. Trastuzumab have shown a significant outcome advantage after 1-year administration in case of HER2-positive disease. Unfortunately, significant increase in cardiotoxicity has been observed after anthracyclines and trastuzumab therapies...
May 2017: Medical Oncology
https://www.readbyqxmd.com/read/28336789/percutaneous-therapy-for-tricuspid-regurgitation-a-new-frontier-for-interventional-cardiology
#17
EDITORIAL
Samir Kapadia, Amar Krishnaswamy, E Murat Tuzcu
No abstract text is available yet for this article.
May 9, 2017: Circulation
https://www.readbyqxmd.com/read/28329235/improving-public-health-by-improving-clinical-trial-guidelines-and-their-application
#18
Martin J Landray, Jeroen J Bax, Laurence Alliot, Marc Buyse, Adam Cohen, Rory Collins, Gerhard Hindricks, Stefan K James, Sile Lane, Aldo P Maggioni, Ann Meeker-O'Connell, Gunnar Olsson, Stuart J Pocock, Michael Rawlins, Jonathan Sellors, Kaori Shinagawa, Karin R Sipido, Liam Smeeth, Richard Stephens, Murray W Stewart, Wendy Gattis Stough, Fergus Sweeney, Frans Van de Werf, Kerrie Woods, Barbara Casadei
Evidence generated from randomized controlled trials forms the foundation of cardiovascular therapeutics and has led to the adoption of numerous drugs and devices that prolong survival and reduce morbidity, as well as the avoidance of interventions that have been shown to be ineffective or even unsafe. Many aspects of cardiovascular research have evolved considerably since the first randomized trials in cardiology were conducted. In order to be large enough to provide reliable evidence about effects on major outcomes, cardiovascular trials may now involve thousands of patients recruited from hundreds of clinical sites in many different countries...
March 8, 2017: European Heart Journal
https://www.readbyqxmd.com/read/28316035/management-of-percutaneous-coronary-intervention-complications
#19
REVIEW
Gregory Means, Christopher End, Prashant Kaul
With the recent increase in complex coronary interventions including percutaneous coronary intervention (PCI) for chronic total occlusions and complex higher risk (and indicated) patients, the spectrum of potential periprocedural complications and their prompt management has become even more relevant. Vascular access-related problems remain the most prevalent of all PCI complications and with randomized controlled trial data from over 20,000 patients supporting the superiority of radial over femoral access in reducing bleeding and vascular complications, a default radial strategy should be promoted...
April 2017: Current Treatment Options in Cardiovascular Medicine
https://www.readbyqxmd.com/read/28294862/-revascularization-in-stable-ischemic-heart-disease-whether-to-change-the-approach
#20
L L Bershtein, N O Katamadze, A E Golovina, S A Sayganov
Current international guidelines on stable ischemic heart disease (IHD) state that coronary revascularization is indicated in cases of: limiting ischemic symptoms while on optimal medical therapy (OMT); high risk coronary anatomy; high risk stress test result. At the same time, many results supporting these conclusions were obtained in relatively old studies, conducted when the approaches to medical therapy and revascularization techniques differed greatly from contemporary practice. Many of the conclusions have been based on data from observational studies and subanalyses of randomized clinical trials, therefore methodologically are not sufficiently reliable...
April 2016: Kardiologiia
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