2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials

Abstract

Preamble 303Foreword 304Introduction 304Methodology 3052.1. Writing Committee Composition 3052.2. Relationships With Industry and Other Entities 3052.3. Review of Literature and Existing Data Definitions 3052.4. Development of Terminology Concepts 3052.5. Consensus Development 3062.6. Relation to Other Standards 3062.7. Peer Review, Public Review, and Board Approval 306Data Elements and Definitions 3063.1. Death Attribution 3063.1.1. Cardiovascular Cause of Death 3073.1.2. Noncardiovascular Cause of Death 3073.1.3. Undetermined Cause of Death 3073.2. Myocardial Infarction 3073.3. Hospitalization for Unstable Angina 3083.4. Transient Ischemic Attack and Stroke 3083.5. Heart Failure Event 3083.6. Percutaneous Coronary Intervention 3093.7. Peripheral Vascular Intervention 3093.8. Stent Thrombosis 309Informatics of Controlled Vocabularies 310References 310Appendix 1. Author Relationships With Industry and Other Entities (Relevant)—2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials 313Appendix 2. Reviewer Relationships With Industry and Other Entities—2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials 314Appendix 3. Death Attribution 315Appendix 4. Myocardial Infarction 318Appendix 5. Hospitalization for Unstable Angina 324Appendix 6. Transient Ischemic Attack and Stroke 327Appendix 7. Heart Failure Event 329Appendix 8. Heart Failure Event: Additional Details 334Appendix 9. Percutaneous Coronary Intervention 336Appendix 10. Cardiovascular Anatomy 350Appendix 11. Peripheral Vascular Intervention 356The American College of Cardiology (ACC) and the American Heart Association (AHA) support their members’ goal to improve the care of patients with cardiovascular disease through professional education, research, and development of guidelines and standards and by fostering policies that support optimal patient outcomes. The ACC and AHA recognize the importance of the use of clinical data standards for patient management, assessment of outcomes, and conduct of research, and the importance of …