Cardiovascular Outcomes Research : A Clinician's Guide to Cardiovascular Epidemiology and Clinical Outcomes Trials

• Autore: Maki Kevin C
• Pubblicazione: Cham : , : Springer International Publishing AG, , 2024; ©2024
• Edizione: 1st ed.
• Descrizione fisica: 1 online resource (446 pages)
• Altri autori: WilsonDon P
• Nota di contenuto: Intro -- Foreword -- Preface -- Acknowledgments -- Contents -- Contributors -- Part I: Background and Process -- Evolution of Cardiovascular Outcomes Studies -- 1 Evolution of the Study of Cardiovascular Outcomes -- 2 Types of Observational Studies and Clinical Trials -- 3 Mendelian Randomization Studies -- 4 Types of Cardiovascular Outcomes Trials -- 4.1 Randomized Controlled Trials -- 4.1.1 Explanatory and Pragmatic Trials -- 4.1.2 Registry-Based Randomized Controlled Trials -- 4.1.3 Electronic Health Record-Enabled Trials -- 4.1.4 Time-to-Event Outcome Studies -- 4.1.5 Adaptive Designs -- 4.2 Considerations for Designing Cardiovascular Outcomes Trials -- 4.2.1 Blinding -- 4.2.2 Comparator Group -- 4.2.3 Superiority Vs. Noninferiority Trials -- 4.2.4 Population -- 4.2.5 Outcome Variables -- 4.2.6 Follow-Up Duration -- 4.2.7 Internal and External Validities -- 5 Conclusions -- References -- Statistical Methods for Cardiovascular Outcomes Studies -- 1 Introduction -- 2 Types of Variables -- 2.1 Summarizing One Variable -- 2.2 Relationships Between Two Variables -- 2.3 Comparing Two (or More) Groups -- 2.4 Comparing Two (or More) Groups with Categorical Variables -- 2.5 Comparing Two (or More) Groups with Time-to-Event Variables -- 3 Multivariable Analysis: Know Your Objective -- 4 Observational Studies Vs. Randomized Trials -- 4.1 Types of Observational Studies -- 4.2 Randomized Trials -- 4.3 Target Trials -- 5 Propensity Scores -- 6 Correlated Data -- 7 Missing Data -- 8 Win Ratio -- 9 Hypothesis Testing and Interim Analyses in Clinical Trials -- 10 Bayesian Statistical Analysis -- 11 Statistical Power and Sample Size Considerations -- 12 Adaptive/Platform Trials -- 13 Concluding Thoughts -- References -- Additional Resources -- Pharmaceutical Development and Approval in the United States of Agents to Influence Cardiovascular Health. ; 1 Overview -- 2 Drug Discovery -- 3 Preclinical Studies -- 4 Phase 1 Clinical Trials -- 5 Phase 2 Clinical Trials -- 6 Phase 3 Clinical Trials -- 7 Submission of an Application for the FDA Review -- 8 Key Elements of FDA Guidance for Development of Agents That Affect Cardiovascular Health -- 8.1 Lipoprotein- and Lipid-Altering Therapies -- 8.2 Antihypertensive Agents -- 8.3 Agents for Heart Failure -- 8.4 Agents for Type 2 Diabetes Mellitus -- 8.5 Agents for Body Weight Management -- 8.6 Agents for Nonalcoholic Steatohepatitis -- 9 Drug Removals from the Market -- 10 Conclusion -- References -- Biomarkers and Imaging Modalities to Detect Subclinical Atherosclerotic Cardiovascular Disease -- 1 Overview -- 2 ASCVD and Risk Estimation -- 3 Definition and Purpose of Biomarkers -- 4 High-Sensitivity C-Reactive Protein -- 5 Cardiac Troponin and High-Sensitivity Cardiac Troponin -- 6 Brain Natriuretic Peptide and N-Terminal Pro B-Type Natriuretic Peptide -- 7 Cytokines -- 8 Albuminuria -- 9 Lipoprotein-Associated Phospholipase A2 -- 10 Myeloperoxidase -- 11 Ceramides -- 12 Imaging Modalities -- 13 Coronary Artery Calcium Scoring -- 14 Carotid Intima-Media Thickness -- 15 Pulse Wave Velocity -- 16 Incidental Calcium on Chest Computed Tomography and Mammography -- 17 Summary -- References -- An Overview of the Guideline Development Process for Atherosclerotic Cardiovascular Disease Risk Reduction with an Emphasis on Guidelines for Cholesterol and Dyslipidemia Management -- References -- Implementation Science: Strategies to Improve Adoption and Adherence to Clinical Practice Guidelines -- 1 Introduction to Implementation Science -- 1.1 Definitions -- 1.1.1 Step 1: Defining an Evidence-Based Practice or Intervention -- 1.1.2 Step 2: Choosing a Theory, Model, or Framework -- 1.1.3 Step 3: Assessing Determinants, Barriers, Enablers, and Contexts. ; 1.1.4 Step 4: Selecting Implementation Strategies -- 1.1.5 Step 5: Selecting Options for Monitoring and Evaluation -- 2 Sustained Adoption and Adherence: Maintenance -- 3 Adoption of Guidelines by Clinicians into Practice -- 4 Patient Adherence to Clinical Practice Recommendations -- 5 Mapping Current Strategies in Cardiovascular Disease to the ERIC Compilation -- 5.1 Financial Strategies -- 5.2 Support for Clinicians -- 5.3 Technology-Based Strategies -- 5.4 Educating Patients -- 6 Summary -- References -- Challenges in Developing Evidence-Based Recommendations for Non-Pharmacological Interventions for Atherosclerotic Cardiovascular Disease Risk Reduction -- 1 Introduction -- 2 Guideline Development Process for Lifestyle Interventions for ASCVD -- 3 Challenges to Developing Evidence-Based Guidelines for Lifestyle Interventions for ASCVD Risk Reduction -- 3.1 Infeasibility of Definitive RCTs -- 3.2 Available Clinical Trial Evidence Base -- 3.3 Reliance on Observational Studies -- 4 Future Directions -- 5 Conclusions -- References -- Part II: Overview of Current Evidence in Categories of Interventions -- Lifestyle Interventions and Atherosclerotic Cardiovascular Disease Outcomes -- 1 Introduction -- 2 Dietary Interventions and ASCVD Outcomes -- 2.1 Dietary Patterns and ASCVD Outcomes -- 2.2 Dietary Pattern Quality and ASCVD Outcomes -- 2.3 Dietary Fatty Acids and ASCVD Outcomes -- 2.4 Added Sugar Intake and ASCVD Outcomes -- 2.5 Alcohol Consumption and ASCVD Outcomes -- 3 Physical Activity Interventions and ASCVD Outcomes -- 3.1 Evidence for the Effects of Physical Activity on ASCVD Outcomes -- 4 Body Weight, Adiposity, and ASCVD Outcomes -- 5 Sleep Hygiene and ASCVD Outcomes -- 6 Psychosocial Health, Stress, and ASCVD Outcomes -- 7 Tobacco Use and Cessation and ASCVD Outcomes -- 8 Conclusion -- References. ; Lipids, Lipoproteins, and Cardiovascular Outcomes -- 1 Introduction -- 2 Overview of Lipid and Lipoprotein Physiology -- 3 Lipoproteins and the Development of ASCVD -- 4 Risk Estimation and Laboratory Measurements -- 4.1 Laboratory Measurements -- 4.2 Risk Estimation -- 4.3 Practical Considerations: Fasting vs Non-Fasting Measurements -- 5 LDL-C and CVD Risk -- 5.1 Targeting LDL-C/ApoB-Lipoproteins with Pharmacotherapy to Manage CVD Risk -- 5.1.1 Statins -- 5.1.2 Statins in Select Populations -- 5.1.3 Statins in High-Risk Groups -- 5.1.4 Non-Statin Therapies for LDL-C Lowering -- 5.1.5 Ezetimibe -- 5.1.6 PCSK9 Inhibitors -- 5.1.7 Bempedoic Acid -- 5.1.8 Bile Acid Sequestrants -- 6 Lp(a) and CVD Risk -- 6.1 Current and Future Pharmacological Interventions -- 7 Triglyceride-Rich Lipoproteins, Triglycerides, and CVD Risk -- 7.1 Common Causes of Hypertriglyceridemia and Treatment Approaches -- 7.1.1 Fibrates -- 7.1.2 Omega-3 Fatty Acids -- 7.2 ApoC-III and ANGPTL3 Inhibition Development -- 7.2.1 ApoC-III -- 7.2.2 ANGPTL3 -- 7.3 Less Common Causes of HTG and Treatment Approaches -- 8 HDL and CVD Risk -- 8.1 HDL-C and ASCVD -- 8.2 Targeting HDL -- 9 Conclusion -- References -- Inflammation and Cardiovascular Outcomes -- 1 Introduction -- 2 Molecular Mechanisms of Inflammation in Atherosclerosis -- 2.1 Inflammatory Cytokines and the Inflammasome -- 3 Inflammation and Acute Thrombotic Syndromes -- 4 Biomarkers of Inflammation and Cardiovascular Disease -- 5 Cardiovascular Risk Factors and Inflammation -- 5.1 Dyslipidemia -- 5.2 Hypertension -- 5.3 Diabetes -- 5.4 Metabolic Syndrome -- 5.5 Genetic Risk Factors -- 5.6 Additional Risk Factors -- 6 Rheumatological Disease and Cardiovascular Risk -- 6.1 Mechanisms of Increased Risk in Patients with Chronic Inflammatory Conditions. ; 6.2 Cardiometabolic Effects of Anti-Inflammatory Therapies Used for Rheumatological Diseases -- 7 Targeting the Inflammatory Pathway for Primary and Secondary Prevention of Cardiovascular Disease -- 7.1 Statins -- 7.2 Colchicine -- 7.3 Canakinumab -- 8 Conclusion -- References -- Thrombosis, Hemostasis, and Cardiovascular Outcomes -- 1 Introduction: A History of Thrombosis -- 2 Epidemiology and Pathobiology of Thrombus Formation -- 3 Infection, Inflammation, and Thrombosis -- 4 SARS-CoV-2: The Novel Coronavirus and Thromboembolism -- 5 Cardiovascular Outcomes of Thrombosis -- 6 Outcomes Studies of VTE and MACE -- 7 Hemostasis -- 7.1 Femoral Artery Access -- 7.2 Radial Artery Access -- 8 Pharmacological Agents in the Prevention and Treatment of Thrombosis -- 8.1 Parenteral Anticoagulant Drugs -- 8.1.1 General Use and Clinical Experience -- Heparins -- Unfractionated Heparin (UFH) -- Use of UFH -- Adverse Effects -- Reversal -- LMWHs -- Direct Thrombin Inhibitors (DTIs) -- Selective FXa Inhibitors -- 8.2 Oral Anticoagulant Drugs -- 8.2.1 General Use and Clinical Experience -- Warfarin -- Monitoring -- Side Effects -- Periprocedural Management -- Direct Oral Anticoagulants (DOACs) -- Uses of DOACs -- Side Effects -- Periprocedural Management -- Management of Bleeding -- Reversal -- Novel Anticoagulants in Development -- 8.3 Antiplatelet Drugs -- 8.3.1 Aspirin -- Uses -- Side Effects -- Periprocedural Management -- 8.3.2 Thienopyridines: Irreversible Blockers of P2Y12 -- Uses -- Side Effects -- Periprocedural Management -- 8.3.3 Reversible Blockers of P2Y12 -- Uses -- Side Effects -- Periprocedural Management -- Cangrelor -- 8.3.4 Phosphodiesterase Inhibitors -- Uses -- Side Effects -- Perioperative Management -- 8.3.5 Glycoprotein IIb/IIIa (GPIIb/IIIa) Inhibitors -- Uses -- Side Effects -- 8.3.6 Protease-Activated Receptor (PAR)-1 Inhibitor. ; 8.4 Fibrinolytic Drugs.
• Titolo autorizzato: Cardiovascular Outcomes Research
• ISBN: 3-031-54960-0
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910864196503321
• Lo trovi qui: Univ. Federico II
• Serie: Contemporary Cardiology Series