Filtered By:
Specialty: Cardiology
Management: Food and Drug Administration (FDA)

This page shows you your search results in order of date. This is page number 10.

Order by Relevance | Date

Total 188 results found since Jan 2013.

Acute ischemic stroke: improving access to intravenous tissue plasminogen activator.
This article gives an overview of the recent approaches pursued to improve access to alteplase for acute ischemic stroke patients. Utilization of stroke systems of care, quality metrics, and quality improvement initiatives to improve alteplase treatment rates are discussed. The implementation of Telestroke networks to improve access and timely evaluation by a stroke specialist are also reviewed. Lastly, this review discusses the use of neuroimaging techniques to identify alteplase candidates in stroke of unknown symptom onset or beyond the 4.5-hour treatment window.Expert commentary: Expanding access to alteplase therapy f...
Source: Expert Review of Cardiovascular Therapy - April 25, 2020 Category: Cardiology Tags: Expert Rev Cardiovasc Ther Source Type: research

Icosapent Ethyl: drug profile and evidence of reduced residual cardiovascular risk in patients with statin-managed LDL-C cholesterol.
Authors: Bazarbashi N, Miller M Abstract INTRODUCTION: Icosapent Ethyl (IPE) is a highly purified (>96%) form of eicosapentanoic acid, a marine-derived omega-3 fatty acid known to reduce serum triglyceride levels. Experimental and human studies also support anti-atherosclerotic properties of IPE including antioxidant, anti-inflammatory, endothelial and plaque stabilizing effects. In the Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT)l),the addition of 4 grams IPE daily resulted in a 25% reduction in cardiovascular events beyond statins and other standard of care therapies. ...
Source: Expert Review of Cardiovascular Therapy - April 2, 2020 Category: Cardiology Tags: Expert Rev Cardiovasc Ther Source Type: research

Heart Failure End Points in Cardiovascular Outcome Trials of Sodium Glucose Cotransporter 2 Inhibitors in Patients With Type 2 Diabetes Mellitus: A Critical Evaluation of Clinical and Regulatory Issues.
This report summarizes these discussions and the key takeaway messages from this meeting. PMID: 31841369 [PubMed - in process]
Source: Circulation - December 16, 2019 Category: Cardiology Authors: Butler J, Packer M, Greene SJ, Fiuzat M, Anker SD, Anstrom KJ, Carson PE, Cooper LB, Fonarow GC, Hernandez AF, Januzzi JL, Jessup M, Kalyani RR, Kaul S, Kosiborod M, Lindenfeld J, McGuire DK, Sabatine MS, Solomon SD, Teerlink JR, Vaduganathan M, Yancy CW, Tags: Circulation Source Type: research

Non-Invasive Cardiac Output Monitoring in Cardiogenic Shock: The NICOM Study
The bioreactance technique is a relatively new, totally noninvasive technique that is used to measure cardiac output (CO) and is easy to use. The Non-Invasive Cardiac Output Monitor (NICOM) is 1 such system. Although approved by the Food and Drug Administration for measurement of stroke volume, there is a paucity of literature validating this technology in decompensated heart failure and cardiogenic shock.
Source: Journal of Cardiac Failure - November 17, 2019 Category: Cardiology Authors: Aniket S. Rali, Tyler Buechler, Bridget Van Gotten, Andrew Waters, Zubair Shah, Nicholas Haglund, Andrew Sauer Tags: Brief Report Source Type: research

Sodium –Glucose Cotransporter-2 Inhibitors and Heart Failure Prevention in Type 2 Diabetes
In 2008, the European Medicines Agency and US Food and Drug Administration (FDA) issued industry guidance stating that all future novel glucose-lowering agent trials must undergo routine cardiovascular risk evaluation either before approval or as a post-marketing commitment.1 This mandated that all cardiovascular endpoint committees prospectively adjudicate all major adverse cardiovascular events, including cardiovascular death, non-fatal MI and stroke, occurring across Phase II and III diabetes trials.
Source: Radcliffe Cardiology - November 4, 2019 Category: Cardiology Authors: mehul Source Type: research

Omega-3 Fatty Acids for the Management of Hypertriglyceridemia: A Science Advisory From the American Heart Association.
ular Biology; Council on Lifestyle and Cardiometabolic Health; Council on Cardiovascular Disease in the Young; Council on Cardiovascular and Stroke Nursing; and Council on Clinical Cardiology Abstract Hypertriglyceridemia (triglycerides 200-499 mg/dL) is relatively common in the United States, whereas more severe triglyceride elevations (very high triglycerides, ≥500 mg/dL) are far less frequently observed. Both are becoming increasingly prevalent in the United States and elsewhere, likely driven in large part by growing rates of obesity and diabetes mellitus. In a 2002 American Heart Association scientific stat...
Source: Circulation - August 18, 2019 Category: Cardiology Authors: Skulas-Ray AC, Wilson PWF, Harris WS, Brinton EA, Kris-Etherton PM, Richter CK, Jacobson TA, Engler MB, Miller M, Robinson JG, Blum CB, Rodriguez-Leyva D, de Ferranti SD, Welty FK, American Heart Association Council on Arteriosclerosis, Thrombosis and Vas Tags: Circulation Source Type: research

Percutaneous devices for left atrial appendage occlusion: A contemporary review.
Abstract Patient with atrial fibrillation (AF) are at risk of developing stroke with the left atrial appendage (LAA) being the most common site for thrombus formation. If left untreated, AF is associated with 4 to 5 folds increase in the risk of ischemic stroke in all age groups. About 5% to 15% of AF patients have atrial thrombi on transesophageal echocardiography, and 91% of those thrombi are located in the LAA in patient with nonrheumatic AF. Although oral anticoagulants are the gold-standard treatment for stroke prevention in patients with non-valvular AF, some patients are at high risk of bleeding and deemed ...
Source: World Journal of Cardiology - February 25, 2019 Category: Cardiology Authors: Moussa Pacha H, Al-Khadra Y, Soud M, Darmoch F, Moussa Pacha A, Alraies MC Tags: World J Cardiol Source Type: research

EP News: Allied Professionals
Using data on patients in the United States Renal Data System (USRDS), Siontis et  al (Circulation 2018; https://doi.org/10.1161/CIRCULATIONAHA.118.035418 [Epub ahead of print], PMID 29954737) sought to assess patterns of apixaban use and outcomes related to use of anticoagulants in patients with end-stage renal disease (ESRD) and atrial fibrillation (AF). As background, patient s with ESRD have both higher risk of bleeding and higher risk of stroke with AF. The Food and Drug Administration has approved updated labeling for the use of apixaban in patients with ESRD on the basis of a small pharmacokinetic study.
Source: Heart Rhythm - July 26, 2018 Category: Cardiology Authors: Erica S. Zado Tags: EP News Source Type: research

The Case for Selective Patent Foramen Ovale Closure After Cryptogenic Stroke Advances in Interventional Cardiology
Controversy has persisted for over a decade whether transcatheter patent foramen ovale (PFO) closure reduces the rate of recurrent ischemic stroke for patients who have had a cryptogenic ischemic stroke and have a PFO. In September 2017, 3 positive randomized trials: RESPECT long-term (Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment trial), REDUCE (GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients With Patent Foramen Ovale [PFO]), and CLOSE (Patent For...
Source: Circulation: Cardiovascular Interventions - March 16, 2018 Category: Cardiology Authors: Wiktor, D. M., Carroll, J. D. Tags: Secondary Prevention, Treatment, Ischemic Stroke Advances in Interventional Cardiology Source Type: research

2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.
senfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ, Standardized Data Collection for Cardiovascular Trials Initiative (SCTI) Abstract This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the US Food and Drug Administration (FDA). The FDA established the Standardized Data Collection for Cardiovascular Trials Initiative in 2009 to simplify the design and conduct of clinical trials in...
Source: Circulation - February 27, 2018 Category: Cardiology Authors: Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Hai MTT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, R Tags: Circulation Source Type: research

Integrating cardioprotective glucose-lowering medications into clinical practice
Patients with type 2 diabetes suffer from both microvascular and macrovascular complications. Optimal glycemic control is well known to reduce the microvascular complications of retinopathy, nephropathy, and neuropathy. However, despite having multiple classes of antidiabetes medications, we have not been able to favorably affect the cardiovascular (CV) complications of diabetes, which cause considerable morbidity and premature CV mortality in patients with diabetes. The recent publication of the EMPA-REG Outcome and the LEADER studies demonstrating favorable CV outcomes with empagliflozin and liraglutide have led to a dec...
Source: Cardiovascular Endocrinology - February 19, 2018 Category: Cardiology Tags: Review articles Source Type: research

Yosprala: A Fixed Dose Combination of Aspirin and Omeprazole
Cardiovascular disease is the leading cause of morbidity and mortality in the United States. Patients who survive a primary cerebrovascular or cardiovascular event are at increased risk of a subsequent occurrence. Antiplatelet therapy plays an essential role for secondary prevention in individuals with stroke, transient ischemic attack, acute or chronic artery disease, or peripheral arterial disease. Maintaining high-risk patients on low-dose aspirin therapy is a fundamental component of management. However, poor adherence, secondary to the drug’s gastrointestinal side effects, has been associated with negative cardiovas...
Source: Cardiology in Review - January 1, 2018 Category: Cardiology Tags: New Therapy Update Source Type: research

Recent Trends in Clot Retrieval Devices: A Review
This article gives an in-depth review of different clot retrieval devices which includes MERCI (the first), the Penumbra Aspiration System, EmboTrap®II, stent retrievers, and the way forward with the new FDA clearance of the devices as first-line treatment for acute ischemic stroke along with IV rt-PA. The review also includes a comparison of clot retrieval devices to gold standard treatment.
Source: Cardiology and Therapy - July 12, 2017 Category: Cardiology Source Type: research