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Randomized trials in cardiology

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https://www.readbyqxmd.com/read/28634218/high-quality-statin-trials-support-the-2013-acc-aha-cholesterol-guidelines-after-hope-3-the-multi-ethnic-study-of-atherosclerosis
#1
Martin B Mortensen, Matthew J Budoff, Dong Li, Khurram Nasir, Michael J Blaha, Veit Sandfort, Carlos J Rodriguez, Pamela Ouyang, Erling Falk
The 2013 American College of Cardiology/American Heart Association (ACC/AHA) guideline on cholesterol treatment to prevent atherosclerotic cardiovascular disease (ASCVD) has been criticized for lowering the risk thresholds for primary prevention with statin therapy. Although the ≥ 7.5% (class I) and ≥ 5% (class IIa) 10-year ASCVD risk thresholds were identified as new indications for treatment by extrapolating results obtained in randomized controlled trials (RCT) of statin therapy, results from population-based European cohorts indicate that >30% of individuals eligible for statin therapy by class I recommendations do not have RCT data supporting statin efficacy...
June 20, 2017: Circulation
https://www.readbyqxmd.com/read/28620111/dietary-fats-and-cardiovascular-disease-a-presidential-advisory-from-the-american-heart-association
#2
REVIEW
Frank M Sacks, Alice H Lichtenstein, Jason H Y Wu, Lawrence J Appel, Mark A Creager, Penny M Kris-Etherton, Michael Miller, Eric B Rimm, Lawrence L Rudel, Jennifer G Robinson, Neil J Stone, Linda V Van Horn
Cardiovascular disease (CVD) is the leading global cause of death, accounting for 17.3 million deaths per year. Preventive treatment that reduces CVD by even a small percentage can substantially reduce, nationally and globally, the number of people who develop CVD and the costs of caring for them. This American Heart Association presidential advisory on dietary fats and CVD reviews and discusses the scientific evidence, including the most recent studies, on the effects of dietary saturated fat intake and its replacement by other types of fats and carbohydrates on CVD...
June 15, 2017: Circulation
https://www.readbyqxmd.com/read/28617684/non-infarct-related-artery-revascularization-in-st-segment-elevation-myocardial-infarction-patients-with-multivessel-disease
#3
Asim N Cheema, Shamir R Mehta, Subodh Verma, Akshay Bagai
PURPOSE OF REVIEW: Multivessel disease (MVD) is common in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) and is associated with significant risk of future cardiovascular (CV) events including short and longer-term mortality. In this review, we examine the pathophysiologic construct contributing to adverse prognosis of MVD in STEMI, relevant available evidence that currently guides the management of the noninfarct-related artery (IRA) stenosis and define the remaining knowledge gaps for future studies...
June 15, 2017: Current Opinion in Cardiology
https://www.readbyqxmd.com/read/28585034/myocardial-perfusion-imaging-in-women-for-the-evaluation-of-stable-ischemic-heart-disease-state-of-the-evidence-and-clinical-recommendations
#4
Viviany R Taqueti, Sharmila Dorbala, David Wolinsky, Brian Abbott, Gary V Heller, Timothy M Bateman, Jennifer H Mieres, Lawrence M Phillips, Nanette K Wenger, Leslee J Shaw
This document from the American Society of Nuclear Cardiology represents an updated consensus statement on the evidence base of stress myocardial perfusion imaging (MPI), emphasizing new developments in single-photon emission tomography (SPECT) and positron emission tomography (PET) in the clinical evaluation of women presenting with symptoms of stable ischemic heart disease (SIHD). The clinical evaluation of symptomatic women is challenging due to their varying clinical presentation, clinical risk factor burden, high degree of comorbidity, and increased risk of major ischemic heart disease events...
June 5, 2017: Journal of Nuclear Cardiology: Official Publication of the American Society of Nuclear Cardiology
https://www.readbyqxmd.com/read/28558846/perioperative-antibiotics-in-pediatric-cardiac-surgery-protocol-for-a-systematic-review
#5
Vijay Anand, Angela Bates, Robin Featherstone, Srinivas Murthy
BACKGROUND: Post-operative infections in pediatric cardiac surgery are an ongoing clinical challenge, with rates between 1 and 20%. Perioperative antibiotics remain the standard for prevention of surgical-site infections, but the type of antibiotic and duration of administration remain poorly defined. Current levels of practice variation through informal surveys are very high. Rates of antibiotic-resistant organisms are increasing steadily around the world. METHODS/DESIGN: We will identify all controlled observational studies and randomized controlled trials examining prophylactic antibiotic use in pediatric cardiac surgery...
May 30, 2017: Systematic Reviews
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
Hitesh C Patel, Carl Hayward, Jason N Dungu, Sofia Papadopoulou, Abdel Saidmeerasah, Robin Ray, 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 7 phase III HFpEF studies (Digitalis Investigation Group Ancillary, Candesartan in Patients With Chronic Heart Failure and Preserved Left-Ventricular Ejection Fraction, Perindopril in Elderly People With Chronic Heart Failure, Irbesartan in Heart Failure With Preserved Systolic Function, Japanese Diastolic Heart Failure, Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist, and Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction [PARAGON-HF; ongoing]) to a typical and well-characterized 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
#20
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
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