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Myocardial Infarction Stabilization

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381. Padeliporfin (Tookad) - prostate cancer / Prostatic Neoplasms

anaesthesia) for the following reasons: withdrew consent after randomisation (3), discontinued by the Investigator for non-compliance (1), myocardial infarction (1), bladder cancer discovered on pre-treatment MRI (1), history of TURP- exclusion criterion (1), previous Gleason 3+4 biopsy - exclusion criterion (1) and unable to undergo pre-treatment MRI due to claustrophobia (1). One subject had an anaphylactic reaction to the anaesthesia and did not receive any Tookad; he was included in the mITT (...) . Management 9 2.2. Quality aspects 10 2.2.1. Introduction 10 2.2.2. Active Substance 11 Manufacture, characterisation and process controls 11 Specification 12 Stability 12 2.2.3. Finished Medicinal Product 13 Manufacture of the product and process controls 14 Product specification 14 Stability of the product 14 Adventitious agents 15 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 15 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 15 2.2.6. Recommendations

2017 European Medicines Agency - EPARs

382. Guselkumab (Tremfya) - Psoriasis

develop PsA 17,18,19 . Psoriasis has also been shown to be associated with a significantly increased risk of Crohn’s disease (relative risk, 3.86, 95% confidence interval [CI] 2.23 to 6.67), which is especially pronounced among psoriatic patients with concomitant PsA (relative risk, 6.43, 95% CI 2.04 to 20.32) 20 . Psoriasis is also associated with an increased risk of occlusive vascular disease, including myocardial infarction (MI) and stroke 21 . Multiple cardiovascular risk factors are associated (...) and occlusive vascular disease. Br J Dermatol. 1978;99(5):469-475. 22 Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB, Gelfand JM. Prevalence of cardiovascular risk factors in patients with psoriasis. J Am Acad Dermatol. 2006;55(5):829-835 23 Gelfand JM, Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB. Risk of myocardial infarction in patients with psoriasis. JAMA. 2006;296(14):1735-1741 24 Mallbris L, Akre O, Granath F, Yin L, Lindelof B, Ekbom A, Stahle-Backdahl M. Increased risk

2017 European Medicines Agency - EPARs

383. Adalimumab (Cyltezo) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis

, characterisation and process controls Description of manufacturing process and process controls Adalimumab active substance (AS) is manufactured, stability tested, and quality-control tested in accordance with good manufacturing practice (GMP) at Boehringer Ingelheim Fremont, Inc. (BIFI), Fremont, California, USA. The active substance is expressed in a transfected Chinese Hamster Ovary (CHO) cell line. Main steps are thawing of working cell bank vials, cell culture and harvest, and purification. During (...) the potential re-filtration of the formulated active substance no other reprocessing is foreseen in the manufacturing process of BI 695501. Intermediate hold times which also included extended hold times under exceptional circumstances as well as media and buffer hold times have been appropriately validated taking into account chemical and microbial stability. Adalimumab (BI 695501) active substance manufacturing process has been adequately described. The ranges of critical process parameters

2017 European Medicines Agency - EPARs

384. Interventional Spine and Pain Procedures in Patients on Antiplatelet and Anticoagulant Medications

in this patient population. Low-dose ASA, when used for secondary prophylaxis, has been shown to reduce the risk of stroke and myocardial infarction in the range of 25% to 30%. Furthermore, the discontinuation of ASA for secondary prophylaxis is associated with significant risk. The lowest effective ASA daily dose for the prevention of TIA and ischemic stroke is 50 mg. For men at high risk of cardiovascular disease, the recommended dose increases to 75 mg. The routine long-term use of doses greater than 75 (...) inhibition of platelet aggregation in healthy volunteers taking an 81-mg dose, ASA demonstrated a 66.0% ± 18.6% inhibition measured with optical aggregometry with the agonist arachidonic acid. Aspirin also influences coagulation through non–TXA 2 -mediated effects, including dose-dependent inhibition of platelet function, suppression of plasma coagulation, and enhancement of fibrinolysis. Secondary hemostasis and thrombus stability are also impaired, because of ASA's acetylation of fibrinogen and its

2018 American Society of Regional Anesthesia and Pain Medicine

385. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Chronic Pain Full Text available with Trip Pro

signaling, including TORC1 (mammalian target of rapamycin complex 1) and brain-derived neurotrophic factor pathways; (5) increased GABA-B levels; and (6) inhibition of brain glycogen synthase kinase 3 (GSK-3B). Inhibition of GSK-3 is a mechanism shared by the mood-stabilizing drug lithium, and the use of adjunct GSK-3B inhibitors such as lithium may augment and prolong ketamine's antidepressant effects. Clinical trials and anecdotal experience have demonstrated efficacy not only for depression, but also (...) channels that mediate “sag” currents, which help regulate and stabilize membrane potential. The mechanisms behind the amnestic effects of ketamine are multifactorial in nature and probably the result of interactions at an assortment of receptors that include NMDA, serotonin, and nicotinic cholinergic. There is growing evidence for ketamine as a treatment for refractory seizures as well as for its use during electroconvulsive therapy. The anticonvulsant effects may be attributable not only to its

2018 American Society of Regional Anesthesia and Pain Medicine

386. CRACKCast E152 – Cardiovascular Drugs

such as tetrahydrozoline and oxymetazoline sedative-hypnotic drug overdose, hypoglycemic drug ingestion, opioid overdose, CNS injury or infection, endocrine-metabolic disorder, sepsis, and acute myocardial infarction. 2. List 6 non-cardiac symptoms of cardioactive steroid intoxication General Weakness Fatigue Malaise GI NV Anorexia AP Diarrhea Optho Blurred vision Photophobia Chromatopsia Transient amblyopia, diplopia, scotomas, blindness Neurologic Dizziness HA Confusion Visual or auditory hallucinations Paranoid (...) Adrenergic Blockers Have B1 effects: Competitively inhibit endogenous catecholamines such as epinephrine at beta-adrenergic receptors, blocking the catecholamine effects of inotropy (increased myocardial contraction), dromotropy (enhanced cardiac conduction), and chronotropy (increased heart rate). Have B2 effects: Complex β2 effects include vascular (smooth muscle relaxation and vasodilation), liver (glycogenolysis, gluconeogenesis), lung (bronchodilation), adipose tissue (release of free fatty acids

2018 CandiEM

387. Cardiovascular Disease and Breast Cancer: Where These Entities Intersect: A Scientific Statement From the American Heart Association Full Text available with Trip Pro

supports the elevated risk that inactivity (<150 min/wk) poses for both CVD and breast cancer. , Globally, physical inactivity is believed to be responsible for 12.2% of the burden of myocardial infarction after accounting for other CVD risk factors including cigarette smoking, hypertension, obesity, dyslipidemia, alcohol, and psychosocial factors. A meta-analysis of longitudinal studies of women found that the RRs of incident CHD were 0.83 (95% CI, 0.69–0.99), 0.77 (95% CI, 0.64–0.92), 0.72 (95% CI (...) therapy when heart is in the field of treatment (<30 Gy) Presence of any of the following risk factors in addition to treatment with lower-dose anthracycline or trastuzumab alone: Older age at time of cancer treatment (≥60 y) ≥2 CVD risk factors during or after cancer treatment: diabetes mellitus, dyslipidemia, hypertension, obesity, smoking History of myocardial infarction, moderate valvular disease, or low-normal left ventricular function (50%–55%) before or during cancer treatment Cancer patients

2018 American Heart Association

388. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm Full Text available with Trip Pro

with dyspnea of unknown origin or worsening dyspnea. Level of recommendation 1 (Strong) Quality of evidence A (High) We suggest coronary revascularization before aneurysm repair in patients with acute ST-segment or non-ST-segment elevation myocardial infarction (MI), unstable angina, or stable angina with left main coronary artery or three-vessel disease. Level of recommendation 2 (Weak) Quality of evidence B (Moderate) We suggest coronary revascularization before aneurysm repair in patients with stable

2018 Society for Vascular Surgery

389. Out-of-Hospital Cardiac Arrest Resuscitation Systems of Care: A Scientific Statement From the American Heart Association

of cases occur without any prior recognized heart disease; half occur without any prodromal symptoms. Despite robust systems of care for patients with trauma and rapidly evolving systems of care for patients with ST-segment–elevation myocardial infarction (STEMI) and stroke, the majority of communities do not achieve optimal survival after OHCA because of large discrepancies in resuscitation-related processes of care. As a result, survival to hospital discharge varies significantly both across (...) the STEMI system coverage ( ). Figure. Coverage of ST-segment–elevation myocardial infarction (STEMI) systems of care in the United States. STEMI plus cardiac resuscitation system coverage as of April 16, 2015 (848 STEMI systems, 83.67% population coverage; 83 cardiac resuscitation systems, 92.5% population coverage). All systems data, including coverage are, are self-reported data. Note: Cardiac resuscitation coverage areas listed are also indicative of an STEMI system in place. Mission: Lifeline does

2018 American Heart Association

390. Outcome Measures Framework: Information Model Report

and an echocardiography study. Medical treatment of valve disease has been limited for the most part to palliation of heart failure (HF) immediately preceding surgical intervention. It does not alter its course or delay the need for surgery. The importance of medical treatment lies in stabilizing the patient’s condition when the disease is due to abnormal valve structure, and in treating the underlying condition when the condition is due to a functional abnormality. 3 This information supports an assessment of how (...) . Within these 35 VHD registries, there were 143 reported outcome measures. In the review process, reviewers mapped these 143 outcomes to 187 various components of the OMF model (some outcomes were mapped to more than one component of the OMF model, resulting in greater than 100% mapping rate). As an example, some outcomes held a mapping to more than one place within the OMF, thus the mapping ratio of outcomes: OMF placement sometimes exceeded and equivalent 1:1 mapping structure (e.g. myocardial

2018 Effective Health Care Program (AHRQ)

391. ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay

-elevation acute coronary syndromes AHA/ACC 2014 (S1.4-9) Heart failure ACC/AHA 2013 (S1.4-10) ST-elevation myocardial infarction ACC/AHA 2013 (S1.4-11) Device-based therapy for cardiac rhythm abnormalities ACC/AHA/HRS 2013 (S1.4-2) Coronary artery bypass graft surgery ACC/AHA 2011 (S1.4-12) Hypertrophic cardiomyopathy ACC/AHA 2011 (S1.4-13) Percutaneous coronary intervention ACC/AHA/SCAI 2011 (S1.4-14) Guidelines for CPR and emergency cardiovascular care—part 9: post-cardiac arrest care AHA 2010 (S1.4 (...) ). The intrinsic sinus and atrioventricular nodal diseases present in a similar clinical manner to extrinsic/secondary processes that can injure the sinus node, atrioventricular node or conduction system tissues. Multiple pathophysiologic processes (e.g., myocardial ischemia or infarction, infiltrative diseases, collagen vascular disease, surgical trauma, endocrine abnormalities, autonomic effects, neuromuscular disorders (S2.1-2, S2.1-8–S2.1-10), individually or in combination, can compromise impulse

2018 American College of Cardiology

392. Stroke Prevention in Patients With Atrial Fibrillation: A Systematic Review Update

—dabigatran 150mg and 110mg vs. warfarin 122 Table 52. Observational studies: myocardial infarction—dabigatran 150mg or 110mg vs. warfarin 123 viii Table 53. Strength of evidence—thrombin inhibitor (dabigatran) vs. warfarin 126 Table 54. Outcomes of interest within rct studies evaluating factor Xa inhibitors: apixaban, rivaroxaban, or edoxaban vs. warfarin 132 Table 55. Observational studies: stroke or systemic embolism—apixaban, rivaroxaban, or edoxaban vs. warfarin 137 Table 56. Observational studies (...) , or edoxaban vs. warfarin 156 Table 61. Observational studies: GI bleeding—apixaban, rivaroxaban, or edoxaban vs. warfarin 158 Table 62. Observational studies, all-cause mortality—apixaban, rivaroxaban, or edoxaban vs. warfarin 161 Table 63. Observational studies: myocardial infarction—apixaban, rivaroxaban, or edoxaban vs. warfarin 164 Table 64. Observational studies: medication non-persistence—apixaban, rivaroxaban, or edoxaban vs. warfarin 166 Table 65. Strength of evidence—factor Xa inhibitors vs

2018 Effective Health Care Program (AHRQ)

394. Sirens to Scrubs: Acute Coronary Syndromes Part Three – Diagnosis and ED Management

in the Emergency Department? Diagnosis of ACS Myocardial infarction (STEMI or nSTEMI) In 2018 the Fourth Universal Definition of Myocardial Infarction was published, which defined an acute myocardial infarction as “Acute myocardial injury with clinical evidence of myocardial ischaemia”. 1 Myocardial injury and myocardial ischemia are further defined… Unstable angina As we explained in Part One, Unstable Angina describes symptoms of myocardial ischemia +/- ECG changes in the absence of elevated serum troponin (...) about the types of MI, including criteria for a Silent MI (page 5 of the document). Below are some nice images from the Fourth Universal Definition of Myocardial Infarction that demonstrate ways in which a Type 1 or 2 MI can occur: 1 Cardiac biomarkers Cardiac biomarkers are proteins that are identified on bloodwork that are suggestive of myocardial injury. Biomarkers have been used in the diagnosis of MI since the 1960s, however, the first biomarkers (aspartate transaminase [AST], lactate

2018 CandiEM

395. Length of stay following percutaneous coronary intervention: An expert consensus document update from the society for cardiovascular angiography and interventions

following PCI has declined. The overall incidence of in‐hospital complications in the most recent report of the NCDR CathPCI registry (2016 Q4–2017 Q3) comprising over 600,000 patients without ST‐segment elevation myocardial infarction (STEMI) or coronary artery bypass surgery (CABG) was 4.8%. Specifically, stroke was 0.2%, bleeding within 72 hr was 1.4%, pericardial tamponade was 0.1%, heart failure was 0.9%, and acute kidney injury (AKI) requiring hemodialysis was 0.2%. PCI complications that resulted (...) for pain, tenderness, numbness, bruising • No difference in adverse events at 7 and 30 days • 6/7 events were related to femoral access site complications 3 hr after PCI • ≤75 years of age • Type A or B lesion • Femoral access siteamenable to vascularclosure device • >2 hr since PCI • Life expectancy <12 months • Acute myocardial infarction • Anticoagulants besides heparin or bivalirudin used during procedure • PCI to nonnative vessel • Evidence of thrombus • Implantation of >3 stents • INR ≥2

2018 Society for Cardiovascular Angiography and Interventions

396. ILCOR Scientific Knowledge Gaps and Clinical Research Priorities for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care: A Consensus Statement Full Text available with Trip Pro

postcardiac arrest physiology could be significant. Emergency Angiography in Comatose Patients After ROSC Numerous observational studies have shown the consistent benefit of emergency angiography and primary percutaneous coronary intervention in comatose patients with ST-segment–elevation myocardial infarction who have achieved ROSC, and a meta-analysis supports use for patients with a mixed pathogenesis of OHCA. The most recent systematic review completed as part of the 2015 CoSTR also confirmed (...) capabilities and survival outcomes. Consistent with other emergent conditions such as trauma and acute myocardial infarction, the concept of cardiac arrest centers that deliver evidence-based postresuscitation care is intuitively appealing. However, as identified in the 2010 and 2015 , CoSTR, there are multiple specific knowledge gaps: the particular treatments to be provided by a cardiac arrest center, the safe patient transport interval (time taken to travel from scene to hospital), the optimal mode

2018 American Heart Association

397. Atherosclerotic Cardiovascular Disease in South Asians in the United States: Epidemiology, Risk Factors, and Treatments: A Scientific Statement From the American Heart Association

better cardiovascular outcomes in South Asians. Studies evaluating cardiovascular events and mortality after isolated coronary artery bypass graft have shown consistently poorer outcomes for South Asians compared with NHW populations. Biological and Nonbiological Mechanisms Contributing to the Excess Risk of ASCVD in South Asians The INTERHEART case-control study enrolled 15 152 cases of first acute myocardial infarction (AMI) and 14 820 sex-matched controls from 52 countries, including 1732 AMI (...) cases and 2204 controls recruited from 5 South Asian countries. The INTERHEART study demonstrated that modifiable risk factors had similar contributions to ASCVD among native South Asians and that the prevalence of traditional risk factors largely accounts for the differences in the earlier age at onset of myocardial infarction (MI) between South Asians and other racial/ethnic groups. Collectively, these traditional risk factors accounted for approximately the same population-attributable risk

2018 American Heart Association

398. Seafood Long-Chain n-3 Polyunsaturated Fatty Acids and Cardiovascular Disease: A Science Advisory From the American Heart Association Full Text available with Trip Pro

myocardial infarction, despite the strong inverse association with sudden cardiac death. Similar findings have been seen in multiple other prospective cohorts. This observation was attributed in part to the antiarrhythmic properties of the LC n-3 PUFAs. Higher seafood intakes have been associated with greater myocyte electric stability, reduced vulnerability to fatal and nonfatal ventricular arrhythmias, , lower heart rate, and improved heart rate variability, each of which is a risk factor (...) , cardiovascular disease; DART, Diet and Reinfarction Trial; DHA, docosahexaenoic acid; EPA, eicosapentaenoic acid; MI, myocardial infarction; NS, nonsignificant; PUFA, polyunsaturated fatty acid; Q, quartile; RR, relative risk; and SD, standard deviation. *Several design and implementation limitations were evident, including lack of a prespecified primary outcome, lack of participant blinding, midtrial revision of randomization procedures to switch from subject choice to take fish advice or fish oil

2018 American Heart Association

400. Cardiopulmonary Resuscitation in Infants and Children With Cardiac Disease Full Text available with Trip Pro

that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Although randomized trials are unavailable, there may be a very clear clinical consensus that a particular test or therapy is useful or effective. *Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations such as sex, age, history of diabetes mellitus, history of prior myocardial infarction, history of heart failure, and prior (...) or de- velop new problems over time, with an increased risk of cardiac arrest. This population commonly develops myocardial dysfunction, arrhythmia, and unbalanced pulmonary and systemic circulation. Specific drugs and the indications for administration and dosing can differ for infants and children with heart disease. In addition, there are many variations of CHD, and the underlying physiological substrates can have a significant impact on systemic perfusion and pulmonary blood flow (PBF

2018 American Heart Association

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