IJCRR - 7(21), November, 2015
CARDIAC BIOMARKERS: PAST, PRESENT AND FUTURE
Author: Rancy Ann Thomas, S. Krishnakumari
Cardiovascular (CV) clinical trials are essential to understand the treatment effects and to follow up the natural progression of CV disease. Biomarkers play a pivotal role in understanding the disease state, risk levels, and clinical decision-making. We review the roles that biomarkers have played in CV clinical trials and roles that CV clinical trials have played and will continue to play in the discovery and validation of biomarkers and their implementation in clinical practice. Biomarkers were once the workhorses of patient selection and endpoint definition in clinical trials; more recently, clinical trials have been the proving ground for individual biomarkers. These markers could also reflect the entire spectrum of disease from the earliest manifestations to the terminal stages. In this paper we review recent advances with the use of biomarkers and a glimpse to the history and future of cardiac markers
Keywords: Cardiovascular diseases, Biomarkers, Clinical trials
Rancy Ann Thomas, S. Krishnakumari. CARDIAC BIOMARKERS: PAST, PRESENT AND FUTURE International Journal of Current Research and Review. 7(21), November, 01-07
1. Naghavi M, Libby P, Falk E, Casscells SW,Litovsky S. From vulnerable plaque to vulnerable patient: a call for new definitions and risk assessment strategies: PartI. Circulation 2003108: 1664-1672.
2. Berenson GS, Srinivasan SR, Bao W, Newman WP, Tracy RE. Association between multiple cardiovascular risk factors and atherosclerosis in children and young adults. The Bogalusa Heart Study. N Engl J Med 1998 338: 1650-1656.
3. Raitakari OT, Juonala M, Kähönen M,Taittonen L ,Laitinen T. Cardiovascular risk factors in childhood and carotid artery intima-media thickness in adulthood: the Cardiovascular Risk in Young Finns Study. JAMA 2003290: 2277-2283.
4. Arthur J Atkinson, Wayne A Colburn, Victor G DeGruttola, David L DeMets, Gregory J. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework*Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clinical Pharmacology and Therapeutics2001 69: 89- 95.
5. Kristian Thygesen, Joseph S. Alpert, Allan S. Jaffe, Maarten L. Simoons, Bernard R. Chaitman, Harvey D. White: the Writing Group on behalf of the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, European Heart Journal 2012 33, 2551–2567.
6. Pearson TA, Mensah GA, and Alexander W. Markers of inflammation and cardiovascular disease: application to clinical and public health practice: a statement for healthcare professionals from the centers for disease control and prevention and the American Heart Association Circulation, 2003.vol. 107, no. 3, pp. 499–511
7. Vasan RS. Biomarkers of cardiovascular disease: molecular basis and practical considerations Circulation, vol. 113, no. 19, pp. 2335–2362, 2006.
8. Alpert JS, Thygesen K, Antman E, Bassand JP. Myocardial infarction redefined–a consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. J Am Coll Cardiol 2000; 36:959–969.
9. Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. A consensus document — myocardial infarction redefined. Eur Heart J 2002; 21:1502–1513.
10. Morrow DA. Chapter in: Cardiovascular biomarkers : pathophysiology and disease management. Humana Press, c2006.
11. ChristensonR, AzzazyHME. Biomarkers of myocardial necrosis: past, present, and future: 2001 3-25.
12. SaengerA. A tale of two biomarkers: the use of troponin and CKMB in con- temporary practice. Clin Lab Sci 2010 23(3):134-40.
13. Braunwald E. Biomarkers in heart failure. The New England Journal of Medicine, Vol. 358, No. 20, May 2008, pp. 2148- 2159, ISSN 0028-4793.
14. Kost GJ, Kirk JD,Omand K. A strategy for the use of cardiac injury markers (troponin I and T, creatine kinase-MB mass and isoforms, and myoglobin) in the diagnosis of acute myocardial infarction. Arch Path Lab Med 1998, 122(3) 245 – 51.
15. Ladenson JH. A personal history of markers of myocyte injury [myocardial infarction]. ClinChimActa 381: 3-8, 2007.
16. Anker SD , von Haehling S. Inflammatory mediators in chronic heart failure: an overview. Heart 2004;90:464-70.
17. Elster SK, Braunwald E , Wood HF. A study of C-reactive protein in the serum of patients with congestive heart failure. Am Heart J 1956;51:533-41.
18. Castell JV, Gómez-Lechón MJ, David M, Fabra R, Trullenque R , Heinrich PC. Acute-phase response of human hepatocytes: regulation of acute-phase protein synthesis by interleukin-6. Hepatology 1990;12:1179-86.
19. Ridker PM. High-sensitivity C-reactive protein: potential adjunct for global risk assessment in the primary prevention of cardiovascular disease. Circulation 2001;103:1813-8.
20. Anand IS, Latini R, Florea VG. C-reactive protein in heart failure: prognostic value and the effect of valsartan. Circulation 2005;112:1428-34.
21. Vasan RS, Sullivan LM, Roubenoff R. Inflammatory markers and risk of heart failure in elderly subjects without prior myocardial infarction: the Framingham Heart Study. Circulation 2003;107: 1486-91.
22. Venugopal SK, Deveraj S, Jialal I. Effect of C-reactive protein on vascular cells: evidence for a proinflammatory, proatherogenic role. Curr Opin Nephrol Hypertens 2005;14:33-7.
23. Levine B, Kalman J, Mayer L, Fillit HM, Packer M. Elevated circulating levels of tumor necrosis factor in severe chronic heart failure. N Engl J Med 1990;323:23641.
24. Seta Y, Shan K, Bozkurt B, Oral H, Mann DL. Basic mechanisms in heart failure: the cytokine hypothesis. J Card Fail 1996;2:243- 9.
25. Lee DS, Vasan RS. Novel markers for heart failure diagnosis and prognosis. Curr Opin Cardiol 2005;20:201-10.
26. Mann DL, McMurray JJ, Packer M. Targeted anticytokine therapy in patients with chronic heart failure: results of the Randomized Etanercept Worldwide Evaluation (RENEWAL). Circulation 2004; 109:1594-602.
27. Okuyama M, Yamaguchi S, Nozaki N, Yamaoka M, Shirakabe M, Tomoike H. Serum levels of soluble form of Fas molecule in patients with congestive heart failure. Am J Cardiol 1997;79:1698-1701.
28. Li Y, Takemura G, Kosai K. Critical roles for the Fas/Fas ligand system in postinfarction ventricular remodeling and heart failure. Circ Res 2004;95:627-36.
29. Kanani PM, Sinkey CA, Browning RL, Allaman M, Knapp HR, Haynes WG. Role of oxidant stress in endothelial dysfunction produced by experimental hyperhomocystinemia in humans. Circulation 1999;100: 1161-8.
30. Ungvári Z, Gupte SA, Recchia FA, Bátkai S , Pacher P. Role of oxidative-nitrosative stress and downstream pathways in various forms of cardiomyopathy and heart failure. Curr Vasc Pharmacol 2005;3: 221-9.
31. Grieve DJ, Shah AM. Oxidative stress in heart failure: more than just damage. Eur Heart J 2003;24:2161-3.
32. Zimmet JM, Hare JM. Nitroso-redox interactions in the cardiovascular system. Circulation 2006;114:1531-44.
33. Hokamaki J and Kawano H, Yoshimura M. Urinary biopyrrins levels are elevated in relation to severity of heart failure. J Am Coll Cardiol 2004;43:1880-5.
34. Polidori MC, Praticó D, Savino K, Rokach J, Stahl W , Mecocci P. Increased F2 isoprostane plasma levels in patients with congestive heart failure are correlated with antioxidant status and disease severity. J Card Fail 2004;10:334-8.
35. Tang WH, Brennan ML, Philip K. Plasma myeloperoxidase levels in patients with chronic heart failure. Am J Cardiol 2006;98:796-799.
36. Anand IS, Fisher LD, Chiang Y-T, Changes in brain natriuretic peptide and norepinephrine over time and mortality and morbidity in the Valsartan Heart Failure Trial (Val-HeFT). Circulation 2003;107: 1278-83.
37. Kameda K, Matsunaga T, Abe N. Correlation of oxidative stress with activity of matrix metalloproteinase in patients with coronary artery disease. Eur Heart J 2003;24:2180-5.
38. Berry CE, Hare JM. Xanthine oxidoreductase and cardiovascular disease: molecular mechanisms and pathophysiological implications. J Physiol 2004;555: 589-606.
39. Kittleson MM, St. John ME, Bead V. Increased levels of uric acid predict haemodynamic compromise in patients with heart failure independently of B-type natriuretic peptide levels. Heart 2007;93: 365-7.
40. Pfeffer MA, Braunwald E. Ventricular remodeling following myocardial infarction: experimental observations and clinical implications. Circulation 1990;81:116172.
41. Querejeta R, Varo N, Lopez B. Serum carboxy-terminal propeptide of procollagen type I is a marker of myocardial fibrosis in hypertensive heart disease. Circulation 2000;101:1729-35.
42. Cicoira M, Rossi A, Bonapace S. Independent and additional prognostic value of aminoterminalpropeptide of type III procollagen circulating levels in patients with chronic heart failure. J Card Fail 2004;10:403-11.
43. King MK, Coker ML, Goldberg A. Selective matrix metalloproteinase inhibition with developing heart failure: effects on left ventricular function and structure. Circ Res 2003;92:177-85.
44. Chidsey CA, Harrison DC, Braunwald E. Augmentation of the plasma norepinephrine response to exercise in patients with congestive heart failure. N Engl J Med 1962;267:650-4.
45. Chidsey CA, Braunwald E, Morrow AG. Catecholamine excretion and cardiac stores of norepinephrine in congestive heart failure. Am J Med 1965;39:442-51.
46. Cohn JN, Levine TB, Olivari MT. Plasma norepinephrine as a guide to prognosis in patients with chronic congestive heart failure. N Engl J Med 1984;311:81923.
47. Swedberg K, Eneroth P, Kjekshus J, Wilhelmsen L. Hormones regulating cardiovascular function in patients with severe congestive heart failure and their relation to mortality. Circulation 1990;82: 1730-6. 48. Teerlink JR. Endothelins: pathophysiology and treatment implications in chronic heart failure. Curr Heart Fail Rep 2005;2:191- 7.
49. Moraes DL, Colucci WS, Givertz MM. Secondary pulmonary hypertension in chronic heart failure: the role of the endothelium in pathophysiology and management. Circulation 2000;102:1718-23.
50. Hülsmann M, Stanek B, Frey B. Value of cardiopulmonary exercise testing and big endothelin plasma levels to predict shortterm prognosis of patients with chronic heart failure. J Am CollCardiol 1998;32:1695-700.
51. Latini R, Masson S,Anand I. The comparative prognostic value of plasma neurohormones at baseline in patients with heart failure enrolled in Val-HeFT. Eur Heart J 2004;25:292-9.
52. Zannad F, Alla F, Dousset B, Perez A, Pitt B. Limitation of excessive extracellular matrix turnover may contribute to survival benefit of spironolactone therapy in patients with congestive heart failure: insights from the Randomized AldactoneEvaluation Study (RALES). Circulation 2000;102:2700-6. [Erratum, Circulation 2001;103:476.]
53. Hayashi M, Tsutamoto T, Wada A. Immediate administration of mineralocorticoid receptor antagonist spironolactone prevents post-infarct left ventricular remodeling associated with suppression of a marker of myocardial collagen synthesis in patients with first anterior acute myocardial infarction. Circulation 2003; 107:2559-65.
54. Schrier RW. Water and sodium retention in edematous disorders: role of vasopressin and aldosterone. Am J Med 2006; 119:Suppl:S47-S53.
55. Masson S, Latini R and Anand IS. The prognostic value of big endothelin-1 in more than 2,300 patients with heart failure enrolled in the Valsartan Heart Failure Trial (Val-HeFT). J Card Fail 2006; 12:375-80.
56. La Vecchia L, Mezzena G and Zanolla L. Cardiac troponin I as diagnostic and prognostic marker in severe heart failure. J Heart Lung Transplant 2000;19:644-52.
57. Horwich TB, Patel J, MacLellan WR, Fonarow GC. Cardiac troponin I is associated with impaired hemodynamics, progressive left ventricular dysfunction, and increased mortality rates in advanced heart failure. Circulation 2003;108:833-8.
58. Khan SQ, O’Brien RJ, Struck J. Prognostic value of midregional pro-adrenomedullin in patients with acute myocardial infarction: the LAMP (Leicester Acute Myocardial Infarction Peptide) study. J Am CollCardiol 2007;49:1525-32.
59. Konstam MA, Gheorghiade M, Burnett JC Jr. Effects of oral tolvaptan in patients hospitalized for worsening heart failure: the EVEREST Outcome Trial. JAMA 2007; 297:1319-31.
60. Peacock WF IV, De Marco T, Fonarow GC. Cardiac troponin and outcome in acute heart failure. N Engl J Med 2008; 358:2117- 26.
61. Vickery S, Price CP, John RI. B-type natriuretic peptide (BNP) and amino-terminal proBNP in patients with CKD: relationship to renal function and left ventricular hypertrophy. Am J Kidney Dis 2005;46:610-20.
62. Maisel AS, Krishnaswamy P, Nowak RM. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med 2002;347:161-7.
63. Mueller C, Scholer A, Laule-Kilian K. Use of B-type natriuretic peptide in the evaluation and management of acute dyspnea. N Engl J Med 2004;350:647-54.
64. Moe GW, Howlett J, Januzzi JL, Zowall H. N-terminal pro-Btype natriuretic peptide testing improves the management of patients with suspected acute heart failure: primary results of the Canadian prospective randomized multicenter IMPROVECHF study. Circulation 2007;115:3103-10.
65. Fonarow GC, Peacock WF, Phillips CO, Givertz MM, Lopatin M. Admission B-type natriuretic peptide levels and in-hospital mortality in acute decompensated heart failure. J Am CollCardiol 2007;49:194350.
66. Jourdain P, Jondeau G, Funck F.Plasma brain natriuretic peptideguided therapy to improve outcome in heart failure: the STARSBNP Multicenter Study. J Am Coll Cardiol 2007;49:1733-9.
67. Suzuki T, Hayashi D, Yamazaki T. Elevated B-type natriuretic peptide levels after anthracycline administration. Am Heart J 1998;136:362-3.
68. Nagaya N, Satoh T, Nishikimi T. Hemodynamic, renal, and hormonal effects of adrenomedullin infusion in patients with congestive heart failure. Circulation 2000;101:498-503.
69. Shimpo M, Morrow DA, Weinberg EO. Serum levels of the interleukin-1 receptor family member ST2 predict mortality and clinical outcome in acute myocardial infarction. Circulation 2004;109: 2186-90.