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Myocardial Infarction Stabilization

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463. SCAI/HFSA Clinical Expert Consensus Document on the Use of Invasive Hemodynamics for the Diagnosis and Management of Cardiovascular Disease Full Text available with Trip Pro

) in myocardial contractility affect the slope of the end‐systolic pressure volume relation. Changes in chamber stiffness affect the shape of the end‐diastolic pressure volume relation (EDPVR), with less (c) or more (d) compliance represented. Ees: end‐systolic elastance; ESP: end‐systolic pressure; ESV: end‐systolic volume; Vo: volume intercept at an LV pressure of zero. [Color figure can be viewed at ] Figure 3 Pressure–volume relations in patients with HFrEF vs. those with HFpEF. In those with HFrEF (...) (intraventricular minus pericardial). These considerations become important when either acute (e.g., RV infarction) or chronic (cardiomyopathy) RV failure complicates the clinical picture. Understanding ventricular interdependence has become particularly important in the management of patients with left ventricular assist devices (LVAD). In these patients, increased LVAD flows can result in excessive LV emptying, reducing device effectiveness and producing exaggerated leftward bowing of the septum and impaired

2017 Society for Cardiovascular Angiography and Interventions

464. 2017 SCAI Appropriate Use Criteria for Peripheral Arterial Interventions

: blood pressure improvement, renal function improvement or stabilization, and improved cardiac destabilization syndromes (heart failure and angina exacerbations) weighed against the risks of the procedure. For lower extremity arterial revascularization, the benefits included: survival or health outcomes such as symptom improvement, limb salvage, functional status and/or quality of life, weighed against the risks of the procedure. “Appropriate Care” implies that the benefits generally outweigh (...) (Class IIb; LOE B) RAS with unstable angina. (Class IIa, LOE B) Asymptomatic unilateral, bilateral, or a solitary viable kidney with hemodynamically significant RAS. (Class IIb; LOE C) RAS = renal artery stenosis; CKD = chronic kidney disease; LOE = level of evidence. Several prospective, multicenter registries have demonstrated improvements in systolic and diastolic blood pressure (SBP, DBP) and improvement and/or stabilization of renal function for renal stent placement with excellent safety

2017 Society for Cardiovascular Angiography and Interventions

465. Optimization of Heart Failure Treatment

of aldosterone antagonists should be assessed within 2 to 3 days and again at 7 days. The schedule for subsequent monitoring should be dictated by the clinical stability of renal function and volume status but should occur at least monthly for the ?rst 3 months and every 3monthsthereafter (2). After the initiation or titration of loop diuretics, renal function should be assessed within 2 to 3 days. During initiation and titration of agents that affect renal function, a decrease in eGFR of >30 (...) . -,NO. -,2017 2017 Pathways for Optimization of Heart Failure Treatment -,2017:-–- 12therapy. Clinical assessment and renal stability in each patient dictates whether clinicians may need to monitor certain patients more closely than others. Social or economicbarriers tocaremay alsoundermine ability to achieve GDMT. For example, homebound pa- tientsorthosewithlimitedabilitytotravelmaybeunable to have blood pressure, heart rate, or renal function assessed in a timely fashion. Cost may also pose a substantial

2017 American College of Cardiology

466. Expert opinion on neuraminidase inhibitors for the prevention and treatment of influenza - review of recent systematic reviews and meta-analyses

. In addition, influenza disease may trigger worsening of chronic medical conditions present before acquiring the influenza infection, especially underlying cardiopulmonary conditions and diabetes, and increase the risk of complications such as cardiovascular events like myocardial infarction and stroke. Influenza viruses constantly change through two main mechanisms: ? antigenic drift which is characterised by point mutations leading to minor and gradual antigenic changes in the surface haemagglutinin (HA (...) of the stockpiles were released for use in Europe, as the normal pharmaceutical supply chains worked sufficiently to cover the demand. The potency and stability of these drugs when maintained as emergency stockpiles is being tested regularly to ensure adequate and retained potency over the years. Request for ECDC expert opinion Neuraminidase inhibitors have been subject to debate concerning their safety, efficacy and effectiveness for treatment and prevention of seasonal influenza infections and its

2017 European Centre for Disease Prevention and Control - Expert Opinion

467. Myocardial knockdown of mRNA-stabilizing protein HuR attenuates post-MI inflammatory response and left ventricular dysfunction in IL-10-null mice Full Text available with Trip Pro

Myocardial knockdown of mRNA-stabilizing protein HuR attenuates post-MI inflammatory response and left ventricular dysfunction in IL-10-null mice Prolonged inflammatory response is associated with left ventricular (LV) dysfunction and adverse remodeling following myocardial infarction (MI). IL-10 inhibits inflammation by suppressing HuR-mediated mRNA stabilization of proinflammatory cytokines. Here we report that following MI, IL-10(-/-) mice showed exaggerated LV dysfunction, fibrosis (...) , and cardiomyocyte apoptosis. Short-hairpin RNA (shRNA)-mediated knockdown of HuR in the myocardium significantly reversed MI-induced LV dysfunctions and LV remodeling. HuR knockdown significantly reduced MI-induced cardiomyocyte apoptosis concomitant with reduced p53 expression. Moreover, HuR knockdown significantly reduced infarct size and fibrosis area, which in turn was associated with decreased TGF-beta expression. In vitro, stable knockdown of HuR in mouse macrophage cell line RAW 264.7 corroborated

2010 The FASEB Journal

468. Effect of Simvastatin-Ezetimibe Compared With Simvastatin Monotherapy After Acute Coronary Syndrome Among Patients 75 Years or Older: A Secondary Analysis of a Randomized Clinical Trial. Full Text available with Trip Pro

July 8, 2010, with the database locked October 21, 2014. Data were analyzed May 29, 2015, through March 13, 2018, using Kaplan-Meier curves and Cox proportional hazards models.Double-blind randomized assignment to combined simvastatin and ezetimibe or simvastatin and placebo with follow-up for a median of 6 years (interquartile range, 4.3-7.1 years).The primary composite end point consisted of death due to cardiovascular disease, myocardial infarction (MI), stroke, unstable angina requiring (...) ezetimibe and simvastatin compared with simvastatin monotherapy to lower lipid levels among patients 75 years or older with stabilized acute coronary syndrome (ACS).In this prespecified secondary analysis of the global, multicenter, prospective clinical randomized Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), outcomes and risks were compared by age among patients 50 years or older after a hospitalization for ACS. Data were collected from October 26, 2005, through

2019 JAMA cardiology Controlled trial quality: predicted high

469. Acute coronary syndrome

=4,258) of all deaths in men and 11% (n=3,283) of all deaths in women, and 17% (n=2,015) and 9% (n=738) of premature deaths in men and women, respectively. 1 Myocardial infarction (MI), which together with unstable angina comprise acute coronary syndrome (ACS), accounted for more than half of all deaths from CHD in Scotland in 2013/14 (50.5% in men; 56% in women), with a third of these being in people under 75 years of age (44% in men and 21% in women). 2 The age-sex standardised incidence of MI (...) the management of undifferentiated chest pain or acute heart failure although the treatment of hypoxia and cardiogenic shock in patients with ACS is considered in section 9. 1.2.2 DEFINITION OF ACUTE CORONARY SYNDROME Acute coronary syndrome encompasses a spectrum of unstable coronary artery disease from unstable angina to transmural myocardial infarction. All have a common aetiology in the formation of thrombus on an inflamed and complicated atheromatous plaque. The principles behind the presentation

2016 SIGN

470. 2016 Focused update of the Canadian Cardiovascular Society guidelines for the management of atrial fibrillation

] for the pre- ceding 12 months), non-ST elevation ACS (NSTEACS), ST segment elevation myocardial infarction (STEMI), or for elective percutaneous coronary intervention (PCI). Up to 30% of patients with AF also have CAD. 8 The man- agement of patients with concomitant AF and CAD is chal- lengingbecauseOACispreferredforthepreventionofSSEinAF patientsatriskofstroke, 3 andAPTtherapy(eithersingleordual APT[DAPT])ispreferredforthepreventionofcoronaryevents inCAD patients afterNSTEACS, STEMI,or PCI. 6,7 Whereas (...) artery disease. Chest 1998;114:611S-33S. 14. Smith P, Arnesen H, Holme I. The effect of warfarin on mortality and reinfarction after myocardial infarction. N Engl J Med 1990;323: 147-52. 15. Hurlen M, Abdelnoor M, Smith P, Erikssen J, Arnesen H. Warfarin, aspirin, or both after myocardial infarction. N Engl J Med 2002;347: 969-74. 16. Fiore LD, Ezekowitz MD, Brophy MT, et al. Department of Veterans Affairs Cooperative Studies Program clinical trial comparing combined warfarin and aspirin with aspirin

2016 CPG Infobase

471. Acute kidney injury: prevention, detection and management

are correct at the time of publication of the guideline (August 2013). Further information is available on the NICE website. Published Published Gener General al Patient experience in adult NHS services. NICE clinical guidance 138 (2012). Medicines adherence. NICE clinical guideline 76 (2009). Acutely ill patients in hospital. NICE clinical guideline 50 (2007). Condition-specific Condition-specific Myocardial infarction with ST-segment-elevation. NICE clinical guideline 167 (2013). Hyperphosphataemia (...) Outcomes. [6] The GDG did not wish to define 'regularly' because this would vary according to clinical need but recognised that daily measurement was typical while in hospital. [7] The frequency of monitoring should be based on the stability and degree of renal function at the time of discharge. Acute kidney injury: prevention, detection and management (CG169) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 25 of 382 2

2013 National Institute for Health and Clinical Excellence - Clinical Guidelines

472. Regular exploratory examination of the need for DMP revision - a feasibility study using the example of the DMP "CHD"

Bedeutung KI Konfidenzintervall LoE Level of Evidence MI Myokardinfarkt NICE National Institute of Health and Care Excellence NSTEMI non ST-segment elevation myocardial infarction (Nicht-ST- Hebungsinfarkt) NVL Nationale VersorgungsLeitlinie PCI percutaneous coronary intervention (perkutane Koronarintervention) PPI Protonenpumpeninhibitor PTCA percutaneous transluminal coronary angioplasty (Ballondilatation) RCT randomized controlled trial (randomisierte kontrollierte Studie) RR relatives Risiko RSA (...) -ÄndV Risikostrukturausgleichsänderungsverordnung SIGN Scottish Intercollegiate Guideline Network SR systematic review (systematische Übersicht) SGB Sozialgesetzbuch STEMI ST-elevation myocardial infarction (Myokardinfarkt mit ST- Streckenhebung) VStG Versorgungsstrukturgesetz WHO World Health Organization Arbeitspapier GA14-06 Version 1.0 DMP Überprüfung 07.10.2014 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) - xiv - Kurzfassung Das Institut für Qualität und

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

473. Association of Fibroblast Growth Factor 23 With Recurrent Cardiovascular Events in Patients After an Acute Coronary Syndrome: A Secondary Analysis of a Randomized Clinical Trial. Full Text available with Trip Pro

after an acute coronary syndrome (ACS).C-terminal FGF-23 was measured in plasma samples using an established enzyme-linked immunosorbent assay system for 4947 patients within 30 days of ACS (median, 14 days) and with 1 additional CV risk factor in the Stabilization of Plaques Using Darapladib-Thrombolysis in Myocardial Infarction 52 (SOLID-TIMI 52) trial of the lipoprotein-associated phospholipase A2 inhibitor darapladib vs placebo performed from December 1, 2009, to April 24, 2014 (median follow-up (...) [25.8%] female). Patients with higher FGF-23 concentrations were older and more likely female, with a greater proportion of hypertension, diabetes, and previous myocardial infarction. After multivariable adjustment for baseline clinical characteristics and established biomarkers (high-sensitivity troponin I, brain-type natriuretic peptide, and high-sensitivity C-reactive protein), FGF-23 concentration in the top quartile was independently associated with an increased risk of CV death or heart

2018 JAMA cardiology Controlled trial quality: predicted high

475. Palbociclib (Ibrance) - locally advanced or metastatic breast cancer

for toxicology and clinical studies through Phase 2. However, its physical properties were deemed unsuitable for commercial development. Therefore, the free base of palbociclib, which was found to have excellent physical and chemical stability, was selected for commercial use. Palbociclib exhibits polymorphism. The crystalline anhydrous Form A of palbociclib free base is the thermodynamically more stable form within the temperature ranges that are relevant to manufacturing and storage conditions (...) was prepared and used for toxicology and clinical studies through Phase 2. However, its physical properties were deemed unsuitable for commercial development. Therefore, the free base of palbociclib, which was found to have adequate physical and chemical stability, was selected for commercial use. The active substance is packaged in two sealed, low density polyethylene (LDPE) antistatic liners. The bagged material is then inserted in a high density polyethylene (HDPE) drum. The LDPE liner is suitable

2016 European Medicines Agency - EPARs

476. Etelcalcetide (Parsabiv) - reduce the levels of parathyroid hormone in adults who have high levels of this hormone because of their long-term kidney disease (secondary hyperparathyroidism)

of the product 7 2. Scientific discussion 8 2.1. Introduction 8 2.1.1. Problem statement 8 2.1.2. About the product 9 2.2. Quality aspects 9 2.2.1. Introduction 9 2.2.2. Active Substance 10 General information 10 Manufacture, characterisation and process controls 10 Specification 11 Stability 12 2.2.3. Finished Medicinal Product 12 Manufacture of the product and process controls 13 Product specification 13 Stability of the product 14 Adventitious agents 15 2.2.4. Discussion on chemical, pharmaceutical (...) used for toxicological, clinical, stability and validation studies. The results are within the specifications at the time of testing and consistent from batch to batch, taking into account the changes in manufacturing process. Assessment report EMA/664198/2016 Page 12/98 Stability Stability data on 7 batches of active substance at >10% of the stated production scale from the proposed manufacturer stored in the intended commercial package (although smaller scale) for up to 24 months (1 batch for 36

2016 European Medicines Agency - EPARs

477. Ongentys (opicapone) - Parkinson?s disease

processes that were used during development. Stability Stability data were provided for six production scale batches of active substance from the proposed manufacturer using both proposed manufacturing processes. Batches were stored in a container closure system simulating the packaging intended for market for up to 36 months under long term conditions at 25 ºC / 60% RH and 30 ºC / 65% RH and for up to 6 months under accelerated conditions at 40 ºC / 75% RH according to the ICH guidelines. The samples (...) stored at 25 °C were only analysed if the 30 °C samples showed an out of trend or out of specification result. The parameters tested are the same as for release. The analytical methods used were the same as for release and are stability indicating. Assessment report EMA/343011/2016 Page 11/140 All tested parameters were within the specifications and no significant changes or trends were observed over time. Photostability testing following the ICH guideline Q1B was performed on one batch of non

2016 European Medicines Agency - EPARs

478. Uptravi (selexipag) - pulmonary arterial hypertension

, and in 1-octanol/aqueous phosphate buffer, pH 6.9 was found 2.1. Selexipag is achiral. Three crystal forms named Form I, II and III are identified and discussed. All selexipag batches manufactured so far correspond to the polymorphic form I which is sufficiently stable at room temperature. The amounts of Form II and III have been also monitored during stability studies of the clinical batches and registration batches. For all batches, no change in the amount of Form II and Form III can be observed (...) substance because it was never detected in any batch manufactured and during stability studies. Two solvents are routinely tested since these solvents are used in the final step of the manufacturing process. The proposed limit of ACT-333679 is considered acceptable form a toxicological point of view because this is the active metabolite of selexipag. The analytical methods used have been adequately described and non-compendial methods appropriately validated in accordance with the ICH guidelines

2016 European Medicines Agency - EPARs

479. Alprolix (eftrenonacog alfa) - haemophilia B

using in vitro assays and in vivo assays for viruses. Phenotypic characterisation and stability of the WCB was investigated. Information was also provided on the storage, handling and stability of the cell banks (MCB, WCB) as well as on cell bank testing and genotypic stability. Control of critical steps and intermediates A comprehensive overview of the process controls and the acceptable ranges for the operation of critical steps in the rFIXFc active substance manufacturing process is presented (...) in the dossier. In addition, process intermediates were evaluated for stability to establish hold (storage) time limits and conditions. Control of critical steps is based on an initial risk assessment which was conducted to identify critical quality attributes (CQAs) that could potentially impact product efficacy or safety, followed by a further process risk assessment to identify operating parameters that may be further investigated during subsequent process characterisation studies. Following process

2016 European Medicines Agency - EPARs

480. Idelvion (lbutrepenonacog alfa) - haemophilia B

bank and its characteristics have been provided. Sterility of this cell bank, viability, and absence of adventitious agents has been demonstrated. In line with ICH Q5A (R1) “Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin” and ICH Q5D the comparability of the MCB, the WCB and the post production cell bank (PPCB) with respect to identity, the absence of adventitious agents and the genetic stability has been (...) to the IS FIX concentrate and the secondary working reference standard (WRS1) is calibrated against PRS1, maintaining a link between the working standard and the WHO IS FIX concentrate. The labeling of rIX-FP in International Units has been justified. In addition, updated information has been provided for the reference materials used in the other active substance control tests. Stability The stability of the active substance under long-term and accelerated conditions has been investigated in line with ICH

2016 European Medicines Agency - EPARs

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