Clinical Trials In Heart Disease

This text, aimed at the clinical cardiologist, covers the planning of and partcipation in a clinical trial. It interprets the importance of past clinical trials in current clinical practice.

This new edition covers important new trials in cardiology therapies and prevention of cardiovascular problems. The world authorities on pharmacologic clinical trials write about the trials, the outcomes and importance for clinical practice. This book gives the general cardiologist insight into the development of new therapies in cardiology as well as the process of how trials were used for those therapies. In addition to providing a manual for how to establish trials, trials for treatment and prevention are covered.

The pace of therapeutic advances in the treatment of cardiovascular diseases is rapid, and new clinically-relevant information appears with such frequency that it can be extremely challenging for clinicians to keep up. Still, knowledge and interpretation of major clinical trials is crucial for the range of clinicians who manage cardiovascular patients, especially since important trial evidence often needs to be implemented soon after it is published. Confidently apply gold standard treatment for 10 of the most critical areas of cardiology Written by an international team of experts, Cardiovascular Clinical Trials: Putting the Evidence into Practice: Provides a succinct overview of recent major clinical trials - the gold standard for all medical treatment - across all the major cardiovascular subspecialties, to ensure you’re up-to-date on the most critical findings Guides cardiology trainees and clinicians on how cardiovascular clinical trials are designed and conducted, including statistical methodology, so you can conduct and/or appraise future trials yourself Addresses methodology as well as clinical effectiveness Offers evidence-based assessments on the most effective treatments and authoritative clinical information on management of the conditions so you can confidently apply what you learn Physicians, surgeons, specialist nurses – any clinician seeking an accessible resource for designing and conducting cardiovascular trials and then translating their results into practice will appreciate this book’s clear guidance and succinct and practical approach.

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This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.

Thoroughly updated for its Third Edition, this pocket-sized handbook provides easy access to clinical trial data that are crucial in therapeutic decision-making. The book enables clinicians to quickly review the studies that support or refute an intervention and choose the most appropriate, cost-effective treatment. Each chapter summarizes the pathophysiology of a disease and guideline-recommended diagnostic tests and treatments, and presents synopses of the major clinical trials for all therapies. New sections in this Third Edition cover peripheral artery disease and drug-eluting stents. This edition also features expanded coverage of pacers and ICDs and an expanded section on preventive pre-hospital cardiology.

Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.