Biomarkers in cardiovascular clinical trials: Past, present, future

Clinical Chemistry

Volumn 58, Issue 1, 2012, Pages 45-53

  Halim, Sharif A ^a   Newby, L Kristin ^a   Ohman, E Magnus ^a  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ABCIXIMAB; AMINO TERMINAL PRO BRAIN NATRIURETIC PEPTIDE; ANGIOTENSIN RECEPTOR ANTAGONIST; ATORVASTATIN; BIOLOGICAL MARKER; BRAIN NATRIURETIC PEPTIDE; C REACTIVE PROTEIN; CD40 LIGAND; CLOPIDOGREL; CREATINE KINASE; ENOXAPARIN; GLYCOPROTEIN IIB; GLYCOPROTEIN IIIA; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; INTERLEUKIN 1; INTERLEUKIN 6; ISOENZYME; LAMIFIBAN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PRASUGREL; PRAVASTATIN; PROTEIN INHIBITOR; SERUM AMYLOID A; SIMVASTATIN; TIROFIBAN; TROPONIN; TROPONIN I; WARFARIN;

ACUTE CORONARY SYNDROME; ANGINA PECTORIS; ATHEROSCLEROSIS; ATHEROSCLEROTIC PLAQUE; BLOOD LEVEL; CARDIAC PATIENT; CARDIOVASCULAR DISEASE; CONGESTIVE HEART FAILURE; CORONARY ARTERY DISEASE; COST EFFECTIVENESS ANALYSIS; EMERGENCY WARD; GENE EXPRESSION; GENE MUTATION; GOLD STANDARD; HEART FAILURE; HEART INFARCTION; HEART MUSCLE NECROSIS; HUMAN; NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; PHASE 2 CLINICAL TRIAL (TOPIC); REVASCULARIZATION; SENSITIVITY AND SPECIFICITY; SHORT SURVEY; THROMBOCYTE ACTIVATION; TREATMENT OUTCOME;

BIOLOGICAL MARKERS; C-REACTIVE PROTEIN; CARDIOVASCULAR DISEASES; CLINICAL TRIALS AS TOPIC; DISEASE PROGRESSION; HUMANS; INFLAMMATION; NATRIURETIC PEPTIDE, BRAIN; PROGNOSIS; RISK ASSESSMENT; TROPONIN I; TROPONIN T;

EID: 84856069790     PISSN: 00099147     EISSN: 15308561     Source Type: Journal    
DOI: 10.1373/clinchem.2011.165787     Document Type: Short Survey

References (67)

1. Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 2001;69:89-95.
2. Morrow DA, de Lemos JA. Benchmarks for the assessment of novel cardiovascular biomarkers. Circulation 2007;115:949-52. (Pubitemid 46328287)
3. Hamm CW, Ravkilde J, Gerhardt W, Jorgensen P, Peheim E, Ljungdahl L, et al. The prognostic value of serum troponin T in unstable angina. N Engl J Med 1992;327:146-50.
4. Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) IIa Investigators. Randomized trial of intravenous heparin versus recombinant hirudin for acute coronary syndromes. Circulation 1994;90:1631-7.
5. The TIMI-IIIB Investigators. Effects of tissue plasminogen activator and a comparison of early invasive and conservative strategies in unstable angina and non - Q-wave myocardial infarction. Results of the TIMI IIIB trial. Circulation 1994;89:1545-56.
6. Ohman EM, Armstrong PW, Christenson RH, Granger CB, Katus HA, Hamm CW, et al., for the GUSTO IIA Investigators. Cardiac troponin T levels for risk stratification in acute myocardial ischemia. N Engl J Med 1996;335:1333-41. (Pubitemid 26360451)
7. Antman EM, Tanasijevic MJ, Thompson B, Schactman M, McCabe CH, Cannon CP, et al. Cardiac-specific troponin I levels to predict the risk of mortality in patients with acute coronary syndromes. N Engl J Med 1996;335:1342-9. (Pubitemid 26360452)
8. Heeschen C, Hamm CW, Goldmann B, Deu A, Langenbrink L, White HD, for the PRISM Study Investigators. Troponin concentrations for stratification of patients with acute coronary syndromes in relation to therapeutic efficacy of tirofiban. Lancet 1999;354:1757-62.
9. Hamm CW, Heeschen C, Goldmann B, Vahanian A, Adgey J, Miguel CM, et al., for the c7E3 Fab Antiplatelet Therapy in Unstable Refractory Angina (CAPTURE) Study Investigators. Benefit of abciximab in patients with refractory unstable angina in relation to serum troponin T levels. N Engl J Med 1999;340:1623-9. (Pubitemid 29249431)
10. Morrow DA, Antman EM, Tanasijevic M, Rifai N, de Lemos JA, McCabe CH, et al. Cardiac troponin I for stratification of early outcomes and the efficacy of enoxaparin in unstable angina: a TIMI-11B substudy. J Am Coll Cardiol 2000;36:1812-7.
11. Morrow DA, Cannon CP, Rifai N, Frey MJ, Vicari R, Lakkis N, et al., for the TACTICS-TIMI 18 Investigators. Ability of minor elevations of troponins I and T to predict benefit from an early invasive strategy in patients with unstable angina and non-ST elevation myocardial infarction: results from a randomized trial. JAMA 2001;286:2405-12. (Pubitemid 33098158)
12. Newby LK, Ohman EM, Christenson RH, Moliterno DJ, Harrington RA, White HD, et al., for the PARAGON-B Investigators. Benefit of glycoprotein IIb/IIIa inhibition in patients with acute coronary syndromes and troponin T-positive status: the PARAGON-B troponin T substudy. Circulation 2001;103:2891-6. (Pubitemid 32578124)
13. Kastrati A, Mehilli J, Neumann FJ, Dotzer F, ten Berg J, Bollwein H, et al., for the Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 2 (ISARREACT 2) Trial Investigators. Abciximab in patients with acute coronary syndromes undergoing percutaneous coronary intervention after clopidogrel pretreatment: the ISAR-REACT 2 randomized trial. JAMA 2006;295:1531-8.
14. Thygesen K, Alpert JS, White HD, on behalf of the Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. J Am Coll Cardiol 2007;50:2173-95. (Pubitemid 350123680)
15. Morrow DA, Cannon CP, Jesse RL, Newby LK, Ravkilde J, Storrow AB, et al. National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines: Clinical characteristics and utilization of biochemical markers in acute coronary syndromes. Clin Chem 2007;53:552-74. (Pubitemid 46580223)
16. Morrow DA, Wiviott SD, White HD, Nicolau JC, Bramucci E, Murphy SA, et al. Effect of the novel thienopyridine prasugrel compared with clopidogrel on spontaneous and procedural myocardial infarction in the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel - Thrombolysis in Myocardial Infarction 38: an application of the classification system from the universal definition of myocardial infarction. Circulation 2009;119:2758-64.
17. Ross R. Atherosclerosis - an inflammatory disease. N Engl J Med 1999;340:115-26. (Pubitemid 29054847)
18. Libby P, Ridker PM. Novel inflammatory markers of coronary risk: theory versus practice. Circulation 1999;100:1148-50. (Pubitemid 29426587)
19. Ridker PM, Hennekens CH, Buring JE, Rifai N. C-reactive protein and other markers of inflammation in the prediction of cardiovascular disease in women. N Engl J Med 2000;342:836-43. (Pubitemid 30165206)
20. Ridker PM, Rifai N, Stampfer MJ, Hennekens CH. Plasma concentration of interleukin-6 and the risk of future myocardial infarction among apparently healthy men. Circulation 2000;101:1767-72. (Pubitemid 30213096)
21. Morrow DA, Rifai N, Antman EM, Weiner DL, McCabe CH, Cannon CP, Braunwald E. C-reactive protein is a potent predictor of mortality independently of and in combination with troponin T in acute coronary syndromes: a TIMI 11A substudy. J Am Coll Cardiol 1998;31:1460-5. (Pubitemid 28273285)
22. Sabatine MS, Morrow DA, de Lemos JA, Gibson CM, Murphy SA, Rifai N, et al. Multimarker approach to risk stratification in non-ST elevation acute coronary syndromes: simultaneous assessment of troponin I, C-reactive protein, and B-type natriuretic peptide. Circulation 2002;105:1760-3. (Pubitemid 34408881)
23. Toss H, Lindahl B, Siegbahn A, Wallentin L, for the FRISC Study Group. Prognostic influence of increased fibrinogen and C-reactive protein levels in unstable coronary artery disease. Circulation 1997;96:4204-10. (Pubitemid 28007445)
24. Ridker PM, Rifai N, Pfeffer MA, Sacks FM, Moye LA, Goldman S, et al., for the Cholesterol and Recurrent Events (CARE) Investigators. Inflammation, pravastatin, and the risk of coronary events after myocardial infarction in patients with average cholesterol levels. Circulation 1998;98:839-44. (Pubitemid 28397432)
25. Ridker PM, Rifai N, Pfeffer MA, Sacks F, Braunwald E, for the Cholesterol and Recurrent Events (CARE) Investigators. Long-term effects of pravastatin on plasma concentration of C-reactive protein. Circulation 1999;100:230-5. (Pubitemid 29340127)
26. Ridker PM, Rifai N, Clearfield M, Downs JR, Weis SE, Miles JS, Gotto AM Jr, for the Air Force/Texas Coronary Atherosclerosis Prevention Study Investigators. Measurement of C-reactive protein for the targeting of statin therapy in the primary prevention of acute coronary events. N Engl J Med 2001;344:1959-65. (Pubitemid 32568149)
27. Albert MA, Danielson E, Rifai N, Ridker PM, for the PRINCE Investigators. Effect of statin therapy on C-reactive protein levels: the Pravastatin Inflammation/CRP Evaluation (PRINCE): a randomized trial and cohort study. JAMA 2001;286:64-70. (Pubitemid 32606333)
28. Jialal I, Stein D, Balis D, Grundy SM, Adams-Huet B, Devaraj S. Effect of hydroxymethyl glutaryl coenzyme A reductase inhibitor therapy on high sensitive C-reactive protein levels. Circulation 2001;103:1933-5. (Pubitemid 32322218)
29. Maisel AS, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P, et al. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med 2002;347:161-7. (Pubitemid 34764819)
30. McCullough PA, Nowak RM, McCord J, Hollander JE, Herrmann HC, Steg PG, et al., for the BNP Multinational Study Investigators. B-type natriuretic peptide and clinical judgment in emergency diagnosis of heart failure: analysis from Breathing Not Properly (BNP) Multinational Study. Circulation 2002;106:416-22. (Pubitemid 34803684)
31. Maisel A, Hollander JE, Guss D, McCullough P, Nowak R, Green G, et al., and the REDHOT Investigators. Primary results of the Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT): a multicenter study of B-type natriuretic peptide levels, emergency department decision making, and outcomes in patients presenting with shortness of breath. J Am Coll Cardiol 2004;44:1328-33. (Pubitemid 39208893)
32. Bhardwaj A, Rehman SU, Mohammed A, Baggish AL, Moore SA, Januzzi JL Jr. Design and methods of the Pro-B Type Natriuretic Peptide Outpatient Tailored Chronic Heart Failure Therapy (PROTECT) Study. Am Heart J 2010;159:532-8.e1.
33. Boersma E, Pieper KS, Steyerberg EW, Wilcox RG, Chang WC, Lee KL, et al., for the PURSUIT Investigators. Predictors of outcome in patients with acute coronary syndromes without persistent ST-segment elevation. Results from an international trial of 9461 patients. Circulation 2000;101:2557-67. (Pubitemid 30350632)
34. Lee KL, Woodlief LH, Topol EJ, Weaver WD, Betriu A, Col J, et al., for the GUSTO-I Investigators. Predictors of 30-day mortality in the era of reperfusion for acute myocardial infarction. Results from an international trial of 41 021 patients. Circulation 1995;91:1659-68.
35. de Lemos JA, Morrow DA, Bentley JH, Omland T, Sabatine MS, McCabe CH, et al. The prognostic value of B-type natriuretic peptide in patients with acute coronary syndromes. N Engl J Med 2001;345:1014-21.
36. Omland T, Persson A, Ng L, O'Brien R, Karlsson T, Herlitz J, et al. N-terminal pro-B-type natriuretic peptide and long-term mortality in acute coronary syndromes. Circulation 2002;106:2913-8. (Pubitemid 35424741)
37. Olsson LG, Swedberg K, Cleland JG, Spark PA, Komajda M, Metra M, et al. Prognostic importance of plasma NT-pro BNP in chronic heart failure in patients treated with a beta-blocker: results from the Carvedilol or Metoprolol European Trial (COMET) trial. Eur J Heart Fail 2007;9:795-801. (Pubitemid 47225165)
38. Sadanandan S, Cannon CP, Chekuri K, Murphy SA, Dibattiste PM, Morrow DA, et al. Association of elevated B-type natriuretic peptide levels with angiographic findings among patients with unstable angina and non-ST-segment elevation myocardial infarction. J Am Coll Cardiol 2004;44:564-8. (Pubitemid 39078180)
39. Newby LK, Storrow AB, Gibler WB, Garvey JL, Tucker JF, Kaplan AL, et al. Bedside multimarker testing for risk stratification in chest pain units: the Chest Pain Evaluation by Creatine Kinase-MB, Myoglobin, and Troponin I (CHECKMATE) study. Circulation 2001;103:1832-7. (Pubitemid 32328394)
40. James SK, Lindahl B, Siegbahn A, Stridsberg M, Venge P, Armstrong P, et al. N-terminal pro-brain natriuretic peptide and other risk markers for the separate prediction of mortality and subsequent myocardial infarction in patients with unstable coronary artery disease: a Global Utilization of Strategies to Open Occluded Arteries (GUSTO)-IV substudy. Circulation 2003;108:275-81. (Pubitemid 36899016)
41. Hlatky MA, Greenland P, Arnett DK, Ballantyne CM, Criqui MH, Elkind MS, et al., on behalf of the American Heart Association Expert Panel on Subclinical Atherosclerotic Diseases and Emerging Risk Factors and the Stroke Council. Criteria for evaluation of novel markers of cardiovascular risk: a scientific statement from the American Heart Association. Circulation 2009;119:2408-16.
42. Ginsburg GS, Donahue MP, Newby LK. Prospects for personalized cardiovascular medicine: the impact of genomics. J Am Coll Cardiol 2005;46:1615-27. (Pubitemid 41531613)
43. Halim SA, Newby LK. Prognostic biomarkers in individuals with prevalent coronary heart disease. Dis Markers 2009;26:265-71.
44. Hochholzer W, Morrow DA, Giugliano RP. Novel biomarkers in cardiovascular disease: update 2010. Am Heart J 2010;160:583-94.
45. Sabatine MS, Liu E, Morrow DA, Heller E, McCarroll R, Wiegand R, et al. Metabolomic identification of novel biomarkers of myocardial ischemia. Circulation 2005;112:3868-75. (Pubitemid 43739484)
46. Weinberg EO, Shimpo M, De Keulenaer GW, MacGillivray C, Tominaga S, Solomon SD, et al. Expression and regulation of ST2, an interleukin-1 receptor family member, in cardiomyocytes and myocardial infarction. Circulation 2002;106:2961-6. (Pubitemid 35424749)
47. Rosenberg S, Elashoff MR, Beineke P, Daniels SE, Wingrove JA, Tingley WG, et al. Multicenter validation of the diagnostic accuracy of a blood-based gene expression test for assessing obstructive coronary artery disease in nondiabetic patients. Ann Intern Med 2010;153:425-34.
48. Wingrove JA, Daniels SE, Sehnert AJ, Tingley W, Elashoff MR, Rosenberg S, et al. Correlation of peripheral-blood gene expression with the extent of coronary artery stenosis. Circ Cardiovasc Genet 2008;1:31-8.
49. GUSTO IV-ACS Investigators. Effect of glycoprotein IIb/IIIa receptor blocker abciximab on outcome in patients with acute coronary syndromes without early coronary revascularisation: The GUSTO IV-ACS randomised trial. Lancet 2001;357:1915-24.
50. Giugliano RP, White JA, Bode C, Armstrong PW, Montalescot G, Lewis BS, et al. Early versus delayed, provisional eptifibatide in acute coronary syndromes. N Engl J Med 2009;360:2176-90.
51. Antman EM, Cohen M, Bernink PJ, McCabe CH, Horacek T, Papuchis G, et al. The TIMI risk score for unstable angina/non-ST elevation MI: a method for prognostication and therapeutic decision making. JAMA 2000;284:835-42. (Pubitemid 30643610)
52. Granger CB, Goldberg RJ, Dabbous O, Pieper KS, Eagle KA, Cannon CP, et al., for the Global Registry of Acute Coronary Events Investigators. Predictors of hospital mortality in the Global Registry of Acute Coronary Events. Arch Intern Med 2003;163:2345-53. (Pubitemid 37310196)
53. Mehta SR, Granger CB, Boden WE, Steg PG, Bassand JP, Faxon DP, et al., for the TIMACS Investigators. Early versus delayed invasive intervention in acute coronary syndromes. N Engl J Med 2009;360:2165-75.
54. Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, et al., for the JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008;359:2195-207.
55. Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias-Manno D, Barker AH, et al., and the CAST Investigators. Mortality and morbidity in patients receiving encainide, flecainide, or placebo - the Cardiac Arrhythmia Suppression Trial. N Engl J Med 1991;324:781-8.
56. Hulley S, Grady D, Bush T, Furberg C, Herrington D, Riggs B, Vittinghoff E, for the Heart and Estrogen/Progestin Replacement Study (HERS) Research Group. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. JAMA 1998;280:605-13. (Pubitemid 28502636)
57. Anderson JL, Horne BD, Stevens SM, Grove AS, Barton S, Nicholas ZP, et al. Randomized trial of genotype-guided versus standard warfarin dosing in patients initiating oral anticoagulation. Circulation 2007;116:2563-70. (Pubitemid 350179221)
58. Kangelaris KN, Bent S, Nussbaum RL, Garcia DA, Tice JA. Genetic testing before anticoagulation? A systematic review of pharmacogenetic dosing of warfarin. J Gen Intern Med 2009;24:656-64.
59. Collet JP, Cayla G, Cuisset T, Elhadad S, Rangé G, Vicaut E, Montalescot G. Randomized comparison of platelet function monitoring to adjust antiplatelet therapy versus standard of care: rationale and design of the assessment with a double randomization of (1) a fixed dose versus a monitoring-guided dose of aspirin and clopidogrel after DES implantation, and (2) treatment interruption versus continuation, 1 year after stenting (ARCTIC) study. Am Heart J 2011;161:5-12.e5.
60. Price MJ, Berger PB, Teirstein PS, Tanguay JF, Angiolillo DJ, Spriggs D, et al., for the GRAVITAS Investigators. Standard-vs high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention: the GRAVITAS randomized trial. JAMA 2011;305:1097-105.
61. Gustafsson F, Atar D, Pitt B, Zannad F, Pfeffer MA. Maximizing scientific knowledge from randomized clinical trials. Am Heart J 2010;159:937-43.
62. Plump AS, Lum PY. Genomics and cardiovascular drug development. J Am Coll Cardiol 2009;53:1089-100.
63. Higashi MK, Veenstra DL, Kondo LM, Wittkowsky AK, Srinouanprachanh SL, Farin FM, Rettie AE. Association between CYP2C9 genetic variants and anticoagulation-related outcomes during warfarin therapy. JAMA 2002;287:1690-8. (Pubitemid 34289221)
64. Chasman DI, Posada D, Subrahmanyan L, Cook NR, Stanton VP Jr, Ridker PM. Pharmacogenetic study of statin therapy and cholesterol reduction. JAMA 2004;291:2821-7. (Pubitemid 38747801)
65. McNamara DM, Holubkov R, Postava L, Janosko K, MacGowan GA, Mathier M, et al. Pharmacogenetic interactions between angiotensinconverting enzyme inhibitor therapy and the angiotensin-converting enzyme deletion polymorphism in patients with congestive heart failure. J Am Coll Cardiol 2004;44:2019-26. (Pubitemid 39473288)
66. U.S. Food and Drug Administration. Draft guidance for industry and food and drug administration staff-in vitro companion diagnostic devices. http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ ucm262292.htm (Accessed August 2011).
67. Cantor WJ, Newby LK, Christenson RH, Tuttle RH, Hasselblad V, Armstrong PW, et al., and the SYMPHONY and 2nd SYMPHONY Cardiac Markers Substudy Investigators. Prognostic significance of elevated troponin I after percutaneous coronary intervention. J Am Coll Cardiol 2002;39:1738-44.