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Cardiology randomized controlled trial

Franz Messerli
OBJECTIVE: To evaluate the outcomes with use of renin angiotensin system (RAS) blockers compared with other antihypertensive agents in people with diabetes. DESIGN: Meta-analysis. DATA SOURCES AND STUDY SELECTION: PubMed, Embase, and the Cochrane central register of controlled trials databases for randomized trials of RAS blockers versus other antihypertensive agents in people with diabetes mellitus. Outcomes were death, cardiovascular death, myocardial infarction, angina, stroke, heart failure, revascularization, and end stage renal disease...
September 2016: Journal of Hypertension
Antoni Bayes-Genis, Josep Lupón, Allan S Jaffe
Over the last 15 years, the hypothesis that intensified treatment directed at reducing natriuretic peptide (NP) concentrations may improve the outcomes of patients with heart failure (HF) has been scrutinized in several prospective clinical trials, with conflicting results. Collectively, however, the data suggest that NP concentrations may be useful in guiding HF management and improving HF-related morbidity and mortality. In this review, we summarize the existing data investigating the use of NPs as targets for outpatient HF therapy...
August 2016: EJIFCC
Muhammad Sohail Chaudhri, Muhammad Usman Ali Shah, Muhammad Imran Asghar, Rashad Siddiqi, Asif Mahmood Janjua, Afsheen Iqbal
OBJECTIVE: To compare mean per-operative flow capacity between skeletonized and pedicled left internal mammary artery (LIMA) in patients undergoing coronary artery bypass grafting (CABG) surgery. STUDY DESIGN: Randomized control trial. PLACE AND DURATION OF STUDY: Department of Cardiac Surgery, Armed Forces Institute of Cardiology and National Institute of Heart Diseases (AFIC-NIHD), Rawalpindi, Pakistan from February to August, 2013. METHODOLOGY: Patients undergoing CABG for coronary artery disease, under 80 years, excluded by the exclusion criteria; and fulfilling the inclusion criteria were randomly assigned to two groups of 70 each...
September 2016: Journal of the College of Physicians and Surgeons—Pakistan: JCPSP
Franz Messerli
OBJECTIVE: To evaluate the outcomes with use of renin angiotensin system (RAS) blockers compared with other antihypertensive agents in people with diabetes. DESIGN: Meta-analysis. DATA SOURCES AND STUDY SELECTION: PubMed, Embase, and the Cochrane central register of controlled trials databases for randomized trials of RAS blockers versus other antihypertensive agents in people with diabetes mellitus. Outcomes were death, cardiovascular death, myocardial infarction, angina, stroke, heart failure, revascularization, and end stage renal disease...
September 2016: Journal of Hypertension
Eric R Bates, Jacqueline E Tamis-Holland, John A Bittl, Patrick T O'Gara, Glenn N Levine
Recent randomized controlled trials have suggested that patients with ST-segment elevation myocardial infarction and multivessel coronary artery disease may benefit more from multivessel percutaneous coronary intervention (PCI) compared with culprit vessel-only primary PCI. The American College of Cardiology, American Heart Association, and Society for Cardiovascular Angiography and Interventions recently published an updated recommendation on this topic. The purpose of this State-of-the-Art Review is to accurately document existing published reports, describe their limitations, and establish a base for future studies...
September 6, 2016: Journal of the American College of Cardiology
Maria Drakopoulou, Konstantinos Toutouzas, Konstantinos Stathogiannis, Andreas Synetos, George Trantalis, Dimitrios Tousoulis
INTRODUCTION: Lipid profile management is even more critical in patients treated for secondary prevention, since patients with established coronary heart disease are at higher risk of developing events. Current guidelines encourage lifestyle modification and patient engagement in disease prevention. However, the American College of Cardiology/American Heart Association guidelines seem to differ considerably from their predecessors, having an impact on clinical practice of lipid management...
August 23, 2016: Expert Review of Cardiovascular Therapy
David M Dudzinski, R Sacha Bhatia, Michael Y Mi, Eric M Isselbacher, Michael H Picard, Rory B Weiner
Importance: Appropriate use criteria-based educational initiatives have been shown to improve transthoracic echocardiography (TTE) ordering practices of physicians in training. Whether such an intervention is successful with attending cardiologists remains unknown. Objective: To prospectively investigate the effect of an appropriate use criteria-based educational intervention on ordering of outpatient TTEs by attending academic cardiologists. Design, Setting, and Participants: We conducted a prospective, randomized clinical trial of an educational intervention designed to reduce the number of outpatient TTEs that were deemed to be rarely appropriate by published appropriate use criteria...
August 10, 2016: JAMA Cardiology
Humaira Jamshed, Anwar-Ul-Hassan Gilani, Fateh Ali Tipoo Sultan, Faridah Amin, Jamshed Arslan, Sumaira Ghani, Madiha Masroor
OBJECTIVE: Elevated serum uric acid (UA), a biomarker of renal insufficiency, is also an independent prognostic marker for morbidity in coronary artery disease (CAD) and poses serious health risks. This study reports the effect of almond consumption on UA in CAD patients. STUDY DESIGN: A randomized controlled clinical trial was conducted with three groups: no-intervention (NI), Pakistani almonds (PA) or American almonds (AA). Patients were recruited from the Cardiology Clinics, Aga Khan University Hospital...
2016: Nutrition Journal
J Wouter Jukema, Maddalena Lettino, Petr Widimský, Nicolas Danchin, Alfredo Bardaji, Jose A Barrabes, Angel Cequier, Marc J Claeys, Leonardo De Luca, Jakob Dörler, David Erlinge, Paul Erne, Patrick Goldstein, Sasha M Koul, Gilles Lemesle, Thomas F Lüscher, Christian M Matter, Gilles Montalescot, Dragana Radovanovic, Jose Lopez-Sendón, Petr Tousek, Franz Weidinger, Clive F M Weston, Azfar Zaman, Uwe Zeymer
Patient registries that document real-world clinical experience play an important role in cardiology as they complement the data from randomized controlled trials, provide valuable information on drug use and clinical outcomes, and evaluate to what extent guidelines are followed in practice. The Platelet Inhibition Registry in ACS EvalUation Study (PIRAEUS) project is an initiative of registry holders who are managing national or international registries observing patients with acute coronary syndromes (ACS)...
October 2015: European Heart Journal. Cardiovascular Pharmacotherapy
Nils Cornelis, Roselien Buys
BACKGROUND: Cardiopulmonary exercise testing (CPET) has become part of screening and evaluation in cardiology. The exercise modalities most often used in CPET are the treadmill (TM) and upright bicycle (UB). Nowadays, also the supine bicycle (SB) is becoming more often used, especially when combined with cardiac imaging. OBJECTIVES: Our aim was to examine whether a maximal CPET on a SB leads to similar results as TM and UB in terms of different CPET measures. Secondly, we explored whether peak VO2 relates to the person's preference and experience with the different exercise modalities...
November 1, 2016: International Journal of Cardiology
Stephanie P B Caligiuri, Grant N Pierce
Despite advancements in hypertensive therapies, the prevalence of hypertension and associated morbidities are still immense. Physicians are in great need for updated information on novel and effective anti-hypertensive therapies. Therefore, the study objective was to provide comprehensive information on the efficacy of available anti-hypertensive therapies. Anti-hypertensive therapies were divided into four general approaches: diet, nutritional supplements, lifestyle modification, and conventional anti-hypertensive medications...
August 5, 2016: Critical Reviews in Food Science and Nutrition
Na Zhao, Jin Xu, Balwinder Singh, Xuerong Yu, Taixiang Wu, Yuguang Huang
BACKGROUND: Cardiac complications are not uncommon in patients undergoing non-cardiac surgery, especially in patients with coronary artery disease (CAD) or at high risk of CAD. Perioperative cardiac complications can lead to mortality and morbidity, as well as higher costs for patient care. Nitrates, which are among the most commonly used cardiovascular drugs, perform the function of decreasing cardiac preload while improving cardiac blood perfusion. Sometimes, nitrates are administered to patients undergoing non-cardiac surgery to reduce the incidence of cardiac complications, especially for patients with CAD...
2016: Cochrane Database of Systematic Reviews
Chee Yoong Foo, Daniel D Reidpath, Nathorn Chaiyakunapruk
BACKGROUND: Acute myocardial infarction (AMI) is a medical emergency in which sudden occlusion of coronary artery(ies) results in ischemia and necrosis of the cardiac tissues. Reperfusion therapies that aim at reopening the occluded artery remain the mainstay of treatment for AMI. Primary percutaneous coronary intervention (PCI), which enables the restoration of blood flow by reopening the occluded artery(ies) via a catheter with an inflatable balloon, is currently the preferred treatment for AMI with ST segment elevation (STEMI)...
2016: Systematic Reviews
Steven Kesten, John K Fraser
Adipose derived regenerative cells (ADRCs) are a heterogeneous population of cells including multipotent adipose derived stems cells, other progenitor cells, fibroblasts, T-regulatory cells, and macrophages. Preclinical data exist supporting benefits that are predominantly through angiogenesis, modulation of inflammation, and wound remodeling. Such effects are likely paracrine in nature. The application of autologous ADRCs has been investigated across multiple therapeutic areas. While there are numerous publications, there is a relative lack of double-blind, well-controlled, randomized clinical trials in the literature...
July 29, 2016: Surgical Technology International
Stephen K Kidd, Marc P Bonaca, Eugene Braunwald, Gaetano M De Ferrari, Basil S Lewis, Piera A Merlini, Sabina A Murphy, Benjamin M Scirica, Harvey D White, David A Morrow
BACKGROUND: Our dual aims were as follows: (1) to classify new or recurrent myocardial infarctions (MI) in patients with stable atherosclerosis using the Universal Definition of MI classification system; and (2) to characterize the effects of vorapaxar, a first-in-class platelet protease-activated receptor -1 antagonist, on new or recurrent MI. METHODS AND RESULTS: We analyzed data from TRA 2°P-TIMI 50, a multinational, randomized, double-blind, placebo-controlled trial of vorapaxar...
July 2016: Journal of the American Heart Association
Matthias Waliszewski, Harald Rittger
BACKGROUND: Randomized controlled trials are the gold standard for demonstrating safety and efficacy of coronary devices with or without accompanying drug treatments in interventional cardiology. With the advent of last-generation drug-eluting stents having enhanced technical attributes and long-term clinical benefits, the proof of incremental angiographic or long-term clinical efficacy becomes more challenging. The purpose of this review is to provide an overview of the most common and alternative study endpoints in interventional cardiology and their potential reimbursement value...
October 2016: Therapeutic Advances in Cardiovascular Disease
Héctor Bueno, Pieter de Graeff, Isabelle Richard-Lordereau, Joseph Emmerich, Keith Aa Fox, Carola P Friedman, Christophe Gaudin, Amany El-Gazayerly, Samantha Goldman, Melanie Hemmrich, Robert A Henderson, Anders Himmelmann, Alar Irs, Neville Jackson, Stefan K James, Hugo A Katus, Andrea Laslop, Ian Laws, Roxana Mehran, Seleen Ong, Krishna Prasad, Marco Roffi, Giuseppe Mc Rosano, Martin Rose, Peter R Sinnaeve, Wendy Gattis Stough, Kristian Thygesen, Frans Van de Werf, Claire Varin, Freek Wa Verheugt, Maria de Los Angeles Alonso García
Regulatory authorities interpret the results of randomized controlled trials according to published principles. The European Medicines Agency (EMA) is planning a revision of the 2000 and 2003 guidance documents on clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) to achieve consistency with current knowledge in the field. This manuscript summarizes the key output from a collaborative workshop, organized by the Cardiovascular Round Table and the European Affairs Committee of the European Society of Cardiology, involving clinicians, academic researchers, trialists, European and US regulators, and pharmaceutical industry researchers...
June 29, 2016: European Heart Journal. Acute Cardiovascular Care
Tanja Dekkers, Aleksander Prejbisz, Leo J Schultze Kool, Hans J M M Groenewoud, Marieke Velema, Wilko Spiering, Sylwia Kołodziejczyk-Kruk, Mark Arntz, Jacek Kądziela, Johannes F Langenhuijsen, Michiel N Kerstens, Anton H van den Meiracker, Bert-Jan van den Born, Fred C G J Sweep, Ad R M M Hermus, Andrzej Januszewicz, Alike F Ligthart-Naber, Peter Makai, Gert-Jan van der Wilt, Jacques W M Lenders, Jaap Deinum
BACKGROUND: The distinction between unilateral aldosterone-producing adenoma or bilateral adrenal hyperplasia as causes of primary aldosteronism is usually made by adrenal CT or by adrenal vein sampling (AVS). Whether CT or AVS represents the best test for diagnosis remains unknown. We aimed to compare the outcome of CT-based management with AVS-based management for patients with primary aldosteronism. METHODS: In a randomised controlled trial, we randomly assigned patients with aldosteronism to undergo either adrenal CT or AVS to determine the presence of aldosterone-producing adenoma (with subsequent treatment consisting of adrenalectomy) or bilateral adrenal hyperplasia (subsequent treatment with mineralocorticoid receptor antagonists)...
September 2016: Lancet Diabetes & Endocrinology
Louis A Kerkhoff, Javed Butler, Anita A Kelkar, Supriya Shore, Candace D Speight, Louisa K Wall, Neal W Dickert
BACKGROUND: Cardiovascular clinical trials depend on patient enrollment. Enrollment rates appear inadequate, but little is known about how frequently patients accept or decline offers of enrollment. The objective of this study was to assess trends and predictors of patient acceptance of offers to enroll in clinical trials for cardiovascular disease. METHODS AND RESULTS: We utilized an established database containing all randomized, controlled trials (n=1224) in cardiovascular disease published between 2001 and 2012 in the 8 highest-impact general medical and cardiology journals...
June 2016: Journal of the American Heart Association
Fernando Alfonso, Javier Cuesta, Teresa Bastante, Fernando Rivero, Marcos García-Guimaraes, Teresa Alvarado, Amparo Benedicto, Bernardo Cortese, Robert Byrne, Adnan Kastrati
Bioresorbable vascular scaffolds (BVS) represent a disruptive technology that has caused a new revolution in interventional cardiology. BVS appear to be particularly appealing in patients presenting with an acute myocardial infarction (MI). The available evidence on the value of BVS implantation in this challenging scenario is very promising but still limited. Results come from preliminary small observational studies, prospective registries that include a control group, and from scarce randomized clinical trials with surrogate mechanistic or angiographic primary end-points...
June 2016: Journal of Thoracic Disease
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