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

A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards)

  • ACC/AHA Clinical Data Standards
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Journal of Nuclear Cardiology Aims and scope

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References

  1. Health Insurance Portability and Accountability Act of 1996. Public Law 104-191. 1996.

  2. Hammond WE. Seamless care: what is it; what is its value; what does it require; when might we get it? Stud Health Technol Inform. 2010;155:3–13.

    PubMed  Google Scholar 

  3. Cimino JJ. Desiderata for controlled medical vocabularies in the twenty-first century. Methods Inf Med. 1998;37:394–403.

    PubMed Central  CAS  PubMed  Google Scholar 

  4. Hicks KA, Hung HM, Mahaffey KW, et al. Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials. Available at: http://www.cdisc.org/therapeutic. Accessed August 20, 2014.

  5. Anderson JL, Adams CD, Antman EM, et al. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction): Developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. Circulation. 2007;116:e148–304.

    Article  PubMed  Google Scholar 

  6. Campeau L. Letter: grading of angina pectoris. Circulation. 1976;54:522–3.

    CAS  PubMed  Google Scholar 

  7. Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115:2344–51.

    Article  PubMed  Google Scholar 

  8. Dickstein K, Cohen-Solal A, Filippatos G, et al. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA). Eur J Heart Fail. 2008;10:933–89.

    Article  PubMed  Google Scholar 

  9. Easton JD, Saver JL, Albers GW, et al. Definition and evaluation of transient ischemic attack: a scientific statement for healthcare professionals from the American Heart Association/American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; and the Interdisciplinary Council on Peripheral Vascular Disease. Stroke. 2009;40:2276–93.

    Article  PubMed  Google Scholar 

  10. Hiatt WR, Goldstone J, Smith SC Jr, et al. Atherosclerotic Peripheral Vascular Disease Symposium II: nomenclature for vascular diseases. Circulation. 2008;118:2826–9.

    Article  PubMed  Google Scholar 

  11. Hunt SA, Abraham WT, Chin MH, et al. 2009 Focused update incorporated into the ACC/AHA 2005 guidelines for the diagnosis and management of heart failure in adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the International Society for Heart and Lung Transplantation. Circulation. 2009;119:e391–479.

    Article  PubMed  Google Scholar 

  12. Jneid H, Anderson JL, Wright RS, et al. 2012 ACCF/AHA focused update of the guideline for the management of patients with unstable angina/non-ST-elevation myocardial infarction (updating the 2007 guideline and replacing the 2011 focused update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2012;126:875–910.

    Article  PubMed  Google Scholar 

  13. Thygesen K, Alpert JS, Jaffe AS, et al. Third universal definition of myocardial infarction. Circulation. 2012;126:2020–35.

    Article  PubMed  Google Scholar 

  14. Thygesen K, Alpert JS, Jaffe AS, et al. Third universal definition of myocardial infarction. J Am Coll Cardiol. 2012;60:1581–98.

    Article  PubMed  Google Scholar 

  15. Hendel RC, Bozkurt B, Fonarow GC, et al. ACC/AHA 2013 methodology for developing clinical data standards: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards. Circulation. 2014;129:2346–57.

    Article  PubMed  Google Scholar 

  16. Cannon CP, Brindis RG, Chaitman BR, et al. 2013 ACCF/AHA key data elements and definitions for measuring the clinical management and outcomes of patients with acute coronary syndromes and coronary artery disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Acute Coronary Syndromes and Coronary Artery Disease Clinical Data Standards). Circulation. 2013;127:1052–89.

    Article  PubMed  Google Scholar 

  17. Creager MA, Belkin M, Bluth EI, et al. 2012 ACCF/AHA/ACR/SCAI/SIR/STS/SVM/SVN/SVS key data elements and definitions for peripheral atherosclerotic vascular disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Data Standards (Writing Committee to develop Clinical Data Standards for Peripheral Atherosclerotic Vascular Disease). Circulation. 2012;125:395–467.

    Article  PubMed  Google Scholar 

  18. O’Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;127:529–55.

    Article  PubMed  Google Scholar 

  19. Sacco RL, Kasner SE, Broderick JP, et al. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013;44:2064–89.

    Article  PubMed  Google Scholar 

  20. Weintraub WS, Karlsberg RP, Tcheng JE, et al. ACCF/AHA 2011 key data elements and definitions of a base cardiovascular vocabulary for electronic health records: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Data Standards. Circulation. 2011;124:103–23.

    Article  PubMed  Google Scholar 

  21. Zannad F, Garcia AA, Anker SD, et al. Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document. Eur J Heart Fail. 2013;15:1082–94.

    Article  PubMed  Google Scholar 

  22. Lloyd-Jones DM, Martin DO, Larson MG, et al. Accuracy of death certificates for coding coronary heart disease as the cause of death. Ann Intern Med. 1998;129:1020–6.

    Article  CAS  PubMed  Google Scholar 

  23. Every NR, Parsons L, Hlatky MA, et al. Use and accuracy of state death certificates for classification of sudden cardiac deaths in high-risk populations. Am Heart J. 1997;134:1129–32.

    Article  CAS  PubMed  Google Scholar 

  24. Moussa ID, Klein LW, Shah B, et al. Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI). J Am Coll Cardiol. 2013;62:1563–70.

    Article  PubMed Central  PubMed  Google Scholar 

  25. White H. Avatar of the universal definition of periprocedural myocardial infarction. J Am Coll Cardiol. 2013;62:1571–4.

    Article  PubMed  Google Scholar 

  26. Rankin J. Cerebral vascular accidents in patients over the age of 60. II. Prognosis. Scott Med J. 1957;2:200–15.

    CAS  PubMed  Google Scholar 

  27. Ives DG, Fitzpatrick AL, Bild DE, et al. Surveillance and ascertainment of cardiovascular events. The Cardiovascular Health Study. Ann Epidemiol. 1995;5:278–85.

    CAS  PubMed  Google Scholar 

  28. Binanay C, Califf RM, Hasselblad V, et al. Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness: the ESCAPE trial. JAMA. 2005;294:1625–33.

    Article  PubMed  Google Scholar 

  29. Butman SM, Ewy GA, Standen JR, et al. Bedside cardiovascular examination in patients with severe chronic heart failure: importance of rest or inducible jugular venous distension. J Am Coll Cardiol. 1993;22:968–74.

    Article  CAS  PubMed  Google Scholar 

  30. Dao Q, Krishnaswamy P, Kazanegra R, et al. Utility of B-type natriuretic peptide in the diagnosis of congestive heart failure in an urgent-care setting. J Am Coll Cardiol. 2001;37:379–85.

    Article  CAS  PubMed  Google Scholar 

  31. Davis M, Espiner E, Richards G, et al. Plasma brain natriuretic peptide in assessment of acute dyspnoea. Lancet. 1994;343:440–4.

    Article  CAS  PubMed  Google Scholar 

  32. Drazner MH, Rame JE, Stevenson LW, et al. Prognostic importance of elevated jugular venous pressure and a third heart sound in patients with heart failure. N Engl J Med. 2001;345:574–81.

    Article  CAS  PubMed  Google Scholar 

  33. Drazner MH, Hellkamp AS, Leier CV, et al. Value of clinician assessment of hemodynamics in advanced heart failure: the ESCAPE trial. Circ Heart Fail. 2008;1:170–7.

    Article  PubMed Central  PubMed  Google Scholar 

  34. Kirkpatrick JN, Vannan MA, Narula J, et al. Echocardiography in heart failure: applications, utility, and new horizons. J Am Coll Cardiol. 2007;50:381–96.

    Article  PubMed  Google Scholar 

  35. Maisel AS, Krishnaswamy P, Nowak RM, et al. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med. 2002;347:161–7.

    Article  CAS  PubMed  Google Scholar 

  36. Moe GW, Howlett J, Januzzi JL, et al. N-terminal pro-B-type natriuretic peptide testing improves the management of patients with suspected acute heart failure: primary results of the Canadian prospective randomized multicenter IMPROVE-CHF study. Circulation. 2007;115:3103–10.

    Article  CAS  PubMed  Google Scholar 

  37. Mueller C, Scholer A, Laule-Kilian K, et al. Use of B-type natriuretic peptide in the evaluation and management of acute dyspnea. N Engl J Med. 2004;350:647–54.

    Article  CAS  PubMed  Google Scholar 

  38. Nagueh SF, Appleton CP, Gillebert TC, et al. Recommendations for the evaluation of left ventricular diastolic function by echocardiography. Eur J Echocardiogr. 2009;10:165–93.

    Article  PubMed  Google Scholar 

  39. Nagueh SF, Bhatt R, Vivo RP, et al. Echocardiographic evaluation of hemodynamics in patients with decompensated systolic heart failure. Circ Cardiovasc Imaging. 2011;4:220–7.

    Article  PubMed  Google Scholar 

  40. van Kimmenade RR, Pinto YM, Bayes-Genis A, et al. Usefulness of intermediate amino-terminal pro-brain natriuretic peptide concentrations for diagnosis and prognosis of acute heart failure. Am J Cardiol. 2006;98:386–90.

    Article  PubMed  Google Scholar 

  41. Austen WG, Edwards JE, Frye RL, et al. A reporting system on patients evaluated for coronary artery disease. Report of the Ad Hoc Committee for Grading of Coronary Artery Disease, Council on Cardiovascular Surgery, American Heart Association. Circulation. 1975;51:5–40.

    Article  CAS  PubMed  Google Scholar 

  42. Alderman EL, Stadius M. The angiographic definitions of the bypass angioplasty revascularization investigation. Coronary Artery Disease. 1992;3:1189–207.

    Google Scholar 

  43. Louvard Y, Thomas M, Dzavik V, et al. Classification of coronary artery bifurcation lesions and treatments: time for a consensus! Catheter Cardiovasc Interv. 2008;71:175–83.

    Article  PubMed  Google Scholar 

  44. Medina A. Suarez de Lezo J., Pan M. [A new classification of coronary bifurcation lesions]. Rev Esp Cardiol. 2006;59:183.

    Article  PubMed  Google Scholar 

  45. Hammond WE. eHealth interoperability. Stud Health Technol Inform. 2008;134:245–53.

    PubMed  Google Scholar 

  46. Mead CN. Data interchange standards in healthcare IT–computable semantic interoperability: now possible but still difficult, do we really need a better mousetrap? J Healthc Inf Manag. 2006;20:71–8.

    PubMed  Google Scholar 

  47. Fragoso G, de Coronado S, Haber M, et al. Overview and utilization of the NCI thesaurus. Comp Funct Genomics. 2004;5:648–54.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  48. Komatsoulis GA, Warzel DB, Hartel FW, et al. caCORE version 3: implementation of a model driven, service-oriented architecture for semantic interoperability. J Biomed Inform. 2008;41:106–23.

    Article  PubMed Central  PubMed  Google Scholar 

  49. CDISC Glossary. Available at: http://cdisc.org/therapeutic. Accessed December 12, 2014.

  50. LOINC Test. Available at: http://www.loinc.org. Accessed December 12, 2014.

  51. van Swieten JC, Koudstaal PJ, Visser MC, et al. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988;19:604–7.

    Article  PubMed  Google Scholar 

  52. Radford MJ, Arnold JM, Bennett SJ, et al. ACC/AHA key data elements and definitions for measuring the clinical management and outcomes of patients with chronic heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Heart Failure Clinical Data Standards). Developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation. Circulation. 2005;112:1888–916.

    Article  PubMed  Google Scholar 

  53. NCDR CathPCI Registry v4.4 Coder’s Data Dictionary. Available at: https://www.ncdr.com/WebNCDR/docs/public-data-collection-documents/www.cathpci_v4_codersdictionary_4-4.pdf?sfvrsn=2. Accessed December 12, 2014.

  54. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation. 2011;56:e574–651.

    Google Scholar 

  55. Butman SM, editor. Complications of Percutaneous Coronary Interventions. New York, NY: Springer; 2010.

    Google Scholar 

  56. National Heart, Lung, and Blood Institute. Coronary artery angiographic changes after percutaneous transluminal coronary angioplasty. In: Manual of Operations: NHLBI PTCA Registry. Bethesda, MD: National Heart, Lung, and Blood Institute; 1985:6–9.

  57. Capone G, Wolf NM, Meyer B, et al. Frequency of intracoronary filling defects by angiography in angina pectoris at rest. Am J Cardiol. 1985;56:403–6.

    Article  CAS  PubMed  Google Scholar 

  58. Cannon CP, Braunwald E, McCabe CH, et al. The Thrombolysis in Myocardial Infarction (TIMI) trials: the first decade. J Interv Cardiol. 1995;8:117–35.

    Article  CAS  PubMed  Google Scholar 

  59. STS/ACC TVT Registry v2.0 Coder’s Data Dictionary. Available at: https://www.ncdr.com/TVT/Libraries/TVT_Library/2_0_CoderDataDictionary.sflb.ashx. Accessed December 12, 2014.

  60. Diehm N, Pattynama PM, Jaff MR, et al. Clinical endpoints in peripheral endovascular revascularization trials: a case for standardized definitions. Eur J Vasc Endovasc Surg. 2008;36:409–19.

    Article  CAS  PubMed  Google Scholar 

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Appendices

Appendices

Appendix 1 Author Relationships With Industry and Other Entities (Relevant)—2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials
Appendix 2 Reviewer Relationships With Industry and Other Entities—2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials
Appendix 3 Death Attribution
Appendix 4 Myocardial Infarction
Appendix 5 Hospitalization for Unstable Angina
Appendix 6 Transient Ischemic Attack and Stroke
Appendix 7 Heart Failure Event
Appendix 8 Heart Failure Event: Additional Details
Appendix 9 Percutaneous Coronary Intervention
Appendix 10 Cardiovascular Anatomy. This table describes coronary artery dominance, coronary artery segments, and lower abdominal, pelvic, and lower extremity artery segment concepts. The bulleted lists are the permissible values for the terminology concept; the following rows provide more detail about the individual permissible values. The table includes a draft simple numbering code for the coronary and peripheral artery segments, as well as references to existing coding systems describing the specific segments where available. The numbering code schema uses the letter “a” to designate the ostium, “b” to designate the body, “c” to designate the bifurcation terminus, and “d” to identify a lateral branch of a branch
Appendix 11 Peripheral Vascular Intervention

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2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials. J. Nucl. Cardiol. 22, 1041–1144 (2015). https://doi.org/10.1007/s12350-015-0209-1

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