Search

Background and Purpose: The guidelines presented in this consensus statement are intended to serve researchers, clinicians, reviewers, and regulators in the selection of the most appropriate primary outcome for a clinical trial of cardiac arrest therapies. The American Heart Association guidelines for the treatment of cardiac arrest depend on high-quality clinical trials, which depend on the selection of a meaningful primary outcome. Because this selection process has been the subject of much controversy, a consensus conference was convened with national and international experts, the National Institutes of Health, and the US Food and Drug Administration., Methods: The Research Working Group of the American Heart Association Emergency Cardiovascular Care Committee nominated subject leaders, conference attendees, and writing group members on the basis of their expertise in clinical trials and a diverse perspective of cardiovascular and neurological outcomes (see the online-only Data Supplement). Approval was obtained from the Emergency Cardiovascular Care Committee and the American Heart Association Manuscript Oversight Committee. Preconference position papers were circulated for review; the conference was held; and postconference consensus documents were circulated for review and comments were invited from experts, conference attendees, and writing group members. Discussions focused on (1) when after cardiac arrest the measurement time point should occur; (2) what cardiovascular, neurological, and other physiology should be assessed; and (3) the costs associated with various end points. The final document underwent extensive revision and peer review by the Emergency Cardiovascular Care Committee, the American Heart Association Science Advisory and Coordinating Committee, and oversight committees., Results: There was consensus that no single primary outcome is appropriate for all studies of cardiac arrest. The best outcome measure is the pairing of a time point and physiological condition that will best answer the question under study. Conference participants were asked to assign an outcome to each of 4 hypothetical cases; however, there was not complete agreement on an ideal outcome measure even after extensive discussion and debate. There was general consensus that it is appropriate for earlier studies to enroll fewer patients and to use earlier time points such as return of spontaneous circulation, simple "alive versus dead," hospital mortality, or a hemodynamic parameter. For larger studies, a longer time point after arrest should be considered because neurological assessments fluctuate for at least 90 days after arrest. For large trials designed to have a major impact on public health policy, longer-term end points such as 90 days coupled with neurocognitive and quality-of-life assessments should be considered, as should the additional costs of this approach. For studies that will require regulatory oversight, early discussions with regulatory agencies are strongly advised. For neurological assessment of post-cardiac arrest patients, researchers may wish to use the Cerebral Performance Categories or modified Rankin Scale for global outcomes., Conclusions: Although there is no single recommended outcome measure for trials of cardiac arrest care, the simple Cerebral Performance Categories or modified Rankin Scale after 90 days provides a reasonable outcome parameter for many trials. The lack of an easy-to-administer neurological functional outcome measure that is well validated in post-cardiac arrest patients is a major limitation to the field and should be a high priority for future development.

Background: The American Heart Association (AHA) and the Henrietta B. and Frederick H. Bugher Foundation in 1985 entered into a partnership to establish a group of Centers for Molecular Biology in the Cardiovascular System. The goal was to recruit and train young scientists with medical training to apply molecular and cellular biology knowledge and techniques to cardiovascular problems., Methods and Results: Six Centers have been awarded (three in 1986 and three in 1991), and a total of 110 trainees have been involved as of June 30, 1994. Of these trainees, 77 were recruited and trained by the 1986 Centers. As of June 1994, 88% of these trainees remained in academic medicine and 54% progressed to higher academic ranks; 79% published papers in science and 66% in molecular biology; and 36% obtained extramural funding for their work. On this basis, the 1986 trainees appear to be well on their way to becoming successful academic cardiologists., Conclusions: The AHA-Bugher Foundation Center program has produced a cadre of cardiovascular scientists who are applying molecular biology knowledge to both basic and clinical problems.

Dr Glantz is Professor of Medicine in the Division of Cardiology, the Truth Initiative Distinguished Professor of Tobacco Control, and Director of the Center for Tobacco Control Research and Education at the University of California, San Francisco School of Medicine. He obtained a BSc in aerospace engineering from the University of Cincinnati in 1969 and an MSc and PhD in applied mechanics from Stanford University. He is the author of 4 books, including The Cigarette Papers and Primer of Biostatistics He is also a member of the University of California, San Francisco Cardiovascular Research Institute and Institute for Health Policy Studies and Co-leader of the University of California, San Francisco Comprehensive Cancer Center Tobacco Program. He was elected to the Institute of Medicine in 2005. [ABSTRACT FROM AUTHOR]

This paper provides guidelines for the optimal, rather than minimal, performance of ultrasonic examination of the heart for current clinical applications using conventional echocardiographic equipment. Since the original report of this Inter-Society Commission on Heart Disease Resources Committee in 1975, M-mode echocardiography has continued to be a valuable clinical tool, and two-dimensional echocardiography has been developed. Guidelines are presented for optimal physician and cardiac sonographer training, case loads, space and support systems, equipment design features and performance testing, and administrative considerations. The developing area of Doppler ultrasound and the competitive technologies are noted.

A cluster of papers, important to the history of cardiology and cardiovascular surgery, that were published in volume 1 of Medico-Chirurgical Transactions (1809), are discussed. These include articles by Sir Astley Cooper on ligature of the common carotid artery for aneurysm, John Abernethy on mitral stenosis, and Sir David Dundas on acute rheumatic carditis.

The article presents abstracts on papers related to cardiology including "Quantifying Options for Reducing Coronary Heart Disease Mortality by 2020," "High-Dose Statin Therapy in Patients With Stable Coronary Artery Disease: Treating the Right Patients Based om Individualized Prediction of Treatment Effect," and "Transplantation for Idiopathic Pulmonary Arterial Hypertension: Improvement in the Lung Allocation Score Era."

The article discusses research papers related to cardiology published in various medical journals. It includes a study published in "Cell" about the significant role of macrophages in heart rhythm, a study published in the "Proceedings of the National Academy of Sciences" about the effect of intrauterine exposure to a psychological maternal stress on an individual's longevity, and a study published in "Science Signaling" about relaxation of blood vessel cells after vasoconstriction.

The author reflects on disease management programs in cardiology. It explores the paper by Stewart and colleagues published in the issue of the periodical "Circulation," in which the researchers summarized the results of three trials on value of nurse-led, multidisciplinary, home-based intervention in cardiovascular diseases. The author discusses the role of guidelines to the implementation of disease management programs.