Ultrasound and radiology surrogate endpoints in pharmacological studies

Atherosclerosis

Volumn 224, Issue 1, 2012, Pages 12-24

  Agewall, S ^a   deGroot, E ^b   Marcos Alberca, P ^c   Zamorano, J L ^c   Barrero, A A ^c   Badano, L P ^d   Perrone Filardi, P ^e  

^a ULLEVÅL UNIVERSITY HOSPITAL   (Norway)

^b UNIVERSITY OF AMSTERDAM   (Netherlands)

^c UNIVERSIDAD COMPLUTENSE DE MADRID   (Spain)

^d UNIVERSITY OF PADOVA   (Italy)

^e UNIVERSITY OF NAPLES FEDERICO II   (Italy)

Author keywords

Cardiac computed tomography; Carotid artery; Clinical trial; Flow mediated dilatation; Magnetic resonance imaging; Surrogate endpoint; Ultrasound

Indexed keywords

AMLODIPINE; ATENOLOL; ATORVASTATIN; CANDESARTAN; ENALAPRIL; EZETIMIBE PLUS SIMVASTATIN; FOSINOPRIL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LACIDIPINE; LISINOPRIL; LOSARTAN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; NIFEDIPINE; PLACEBO; SIMVASTATIN; SUPEROXIDE DISMUTASE; TORCETRAPIB; VALSARTAN;

ATHEROSCLEROSIS; BRACHIAL ARTERY; BRAIN ISCHEMIA; CALCIFICATION; CARDIAC RESYNCHRONIZATION THERAPY; CLINICAL EFFECTIVENESS; DIABETES MELLITUS; DISEASE MARKER; DRUG MEGADOSE; ECHOCARDIOGRAPHY; FAMILIAL HYPERCHOLESTEROLEMIA; HEART FAILURE; HEART LEFT VENTRICLE HYPERTROPHY; HEART OUTPUT; HYPERCHOLESTEROLEMIA; HYPEREMIA; HYPERTENSION; INTERNAL CAROTID ARTERY OCCLUSION; LOW DRUG DOSE; MYOCARDIAL PERFUSION IMAGING; NUCLEAR MAGNETIC RESONANCE IMAGING; OXIDATIVE STRESS; PRIORITY JOURNAL; RADIOLOGY; REVIEW; SIGNAL NOISE RATIO; SMOKING; STENOSIS;

ATHEROSCLEROSIS; BIOLOGICAL MARKERS; BRACHIAL ARTERY; CARDIAC OUTPUT; CARDIOVASCULAR DISEASES; CAROTID ARTERIES; CAROTID INTIMA-MEDIA THICKNESS; DILATATION, PATHOLOGIC; ECHOCARDIOGRAPHY; ENDPOINT DETERMINATION; HEART VENTRICLES; HUMANS; MAGNETIC RESONANCE IMAGING;

EID: 84865374373     PISSN: 00219150     EISSN: 18791484     Source Type: Journal    
DOI: 10.1016/j.atherosclerosis.2012.03.038     Document Type: Review

References (121)

1. NIH Definition Working Group Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 2001, 69:89-95.
2. Boissel J.P., Collet J.P., Moleur P., Haugh M. Surrogate endpoints: a basis for a rational approach. Eur J Clin Pharmacol 1992, 43:235-244.
3. Prentice R.L. Statist Med 1989, 8:431-440.
4. Pignoli P., Tremoli E., Poli A., Oreste P., Paoletti R. Intimal plus medial thickness of the arterial wall: a direct measurement with ultrasound imaging. Circulation 1986, 74:1399-1406.
5. Wiegman A., de Groot E., Hutten B.A., et al. Arterial intima-media thickness in children heterozygous for familial hypercholesterolaemia. Lancet 2004, 363:369-370.
6. Touboul P.J., Hennerici M.G., Meairs S., et al. Mannheim carotid intima-media thickness consensus (2004-2006). An update on behalf of the Advisory Board of the 3rd and 4th watching the risk symposium, 13th and 15th European stroke conferences, Mannheim, Germany, 2004, and Brussels, Belgium, 2006. Cerebrovasc Dis 2007, 23:75-80.
7. Inaba Y., Chen J.A., Bergmann S.R. Carorid plaque, compared with carotid intima-media thickness, more accurately predicts coronary artery disease events: a meta-analysis. Atherosclerosis 2012, 220:128-133.
8. Mathiesen E.B., Johnsen S.H., Wilsgaard T., Bønaa K.H., Løchen M.L., Njølstad I. Carotid plaque area and intima-media thickness in prediction of first-ever ischemic stroke: a 10-year follow-up of 6584 men and women: the Tromsø Study. Stroke 2011, 42:972-978.
9. Makris G.C., Lavida A., Griffin M., Geroulakos G., Nicolaides A.N. Three-dimensional ultrasound imaging for the evaluation of carotid atherosclerosis. Atherosclerosis 2011, 219:377-383.
10. Espeland M.A., Byington R.P., Hire D., Davis V.G., Hartwell T., Probstfield J. Analysis strategies for serial multivariate ultrasonographic data that are incomplete. Stat Med 1992, 11:1041-1056.
11. Kastelein J.J., Akdim F., Stroes E.S., et al. ENHANCE Investigators. Simvastatin with or without ezetimibe in familial hypercholesterolemia. N Engl J Med 2008, 358:1431-1443.
12. Kastelein J.J., van Leuven S.I., Burgess L., et al. RADIANCE 1 Investigators. Effect of torcetrapib on carotid atherosclerosis in familial hypercholesterolemia. N Engl J Med 2007, 356:1620-1630.
13. Lorenz M.W., Markus H.S., Bots M.L., Rosvall M., Sitzer M. Prediction of clinical cardiovascular events with carotid intima-media thickness: a systematic review and meta-analysis. Circulation 2007, 115:459-467.
14. Byington R.P., Furberg C.D., Crouse J.R., Espeland M.A., Bond M.G. Pravastatin, lipids, and atherosclerosis in the carotid arteries (PLAC-II). Am J Cardiol 1995, 76:54C-59C.
15. Hodis H.N., Mack W.J., LaBree L., et al. Reduction in carotid arterial wall thickness using lovastatin and dietary therapy: a randomized controlled clinical trial. Ann Intern Med 1996, 124:548-556.
16. MacMahon S., Sharpe N., Gamble G., et al. Effects of lowering average of below-average cholesterol levels on the progression of carotid atherosclerosis: results of the LIPID Atherosclerosis Substudy. LIPID Trial Research Group. Circulation 1998, 97:1784-1790.
17. de Groot E., Jukema J.W., Montauban van Swijndregt A.D., et al. B-mode ultrasound assessment of pravastatin treatment effect on carotid and femoral artery walls and its correlations with coronary arteriographic findings: a report of the Regression Growth Evaluation Statin Study (REGRESS). J Am Coll Cardiol 1998, 31:1561-1567.
18. Smilde T.J., van W.S., Wollersheim H., Trip M.D., Kastelein J.J., Stalenhoef A.F. Effect of aggressive versus conventional lipid lowering on atherosclerosis progression in familial hypercholesterolaemia (ASAP): a prospective, randomised, double-blind trial. Lancet 2001, 357:577-581.
19. Nissen S.E., Tuzcu E.M., Schoenhagen P., et al. REVERSAL Investigators. Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary atherosclerosis: a randomized controlled trial. JAMA 2004, 291:1071-1080.
20. Taylor A.J., Kent S.M., Flaherty P.J., Coyle L.C., Markwood T.T., Vernalis M.N. ARBITER: arterial biology for the investigation of the treatment effects of reducing cholesterol: a randomized trial comparing the effects of atorvastatin and pravastatin on carotid intima medial thickness. Circulation 2002, 106:2055-2060.
21. Furberg C.D., Adams H.P., Applegate W.B., et al. Effect of lovastatin on early carotid atherosclerosis and cardiovascular events. Asymptomatic Carotid Artery Progression Study (ACAPS) Research Group. Circulation 1994, 90:1679-1687.
22. Hedblad B., Wikstrand J., Janzon L., Wedel H., Berglund G. Low-dose metoprolol CR/XL and fluvastatin slow progression of carotid intima-media thickness: main results from the beta-blocker cholesterol-lowering asymptomatic plaque study (BCAPS). Circulation 2001, 103:1721-1726.
23. Mercuri M., Bond M.G., Sirtori C.R., et al. Pravastatin reduces carotid intima-media thickness progression in an asymptomatic hypercholesterolemic mediterranean population: the Carotid Atherosclerosis Italian Ultrasound Study. Am J Med 1996, 101:627-634.
24. Salonen R., Nyyssonen K., Porkkala E., et al. Kuopio Atherosclerosis Prevention Study (KAPS). A population-based primary preventive trial of the effect of LDL lowering on atherosclerotic progression in carotid and femoral arteries. Circulation 1995, 92:1758-1764.
25. Crouse J.R., Raichlen J.S., Riley W.A., et al. METEOR Study Group. Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial. JAMA 2007, 297:1344-1353.
26. Bots M.L., Visseren F.L., Evans G.W., et al. RADIANCE 2 Investigators. Torcetrapib and carotid intima-media thickness in mixed dyslipidaemia (RADIANCE 2 study): a randomised, double-blind trial. Lancet 2007, 370:153-160.
27. Barter P.J., Caulfield M., Eriksson M., et al. ILLUMINATE Investigators. Effects of torcetrapib in patients at high risk for coronary events. N Engl J Med 2007, 357:2109-2122.
28. Meuwese M.C., Duivenvoorden R., Davidson M.D. Effect of ACAT inhibition on progression of carotid atherosclerosis in patients with familial hypercholesterolemia, the CAPTIVATE study. J Clin Lipidol 2007, 1:382.
29. Nicholls S.J., Sipahi I., Schoenhagen P., et al. ACTIVATE Investigators. Intravascular ultrasound assessment of novel antiatherosclerotic therapies: rationale and design of the Acyl-CoA: cholesterol acyltransferase intravascular atherosclerosis treatment evaluation (ACTIVATE) study. Am Heart J 2006, 152:67-74.
30. de Groot E., Hovingh G.K., Duriez P., Smit A.J., Fruchart J.C., Kastelein J.J. Measurement of arterial wall thickness as a surrogate marker for atherosclerosis. Circulation 2004, 109(23 Suppl. 1):III33-III38.
31. Costanzo P., Perrone-Filardi P., Vassallo E., et al. Does carotid intima-media thickness regression predict reduction of cardiovascular events? A meta-analysis of 41 randomized trials. J Am Coll Cardiol 2010, 56:2006-2020.
32. Lorenz MW, Polak JF, Kavousi M, et al. Carotid intima media thickness progression in individuals fails to predict the risk of clinical vascular events in the general population - results from the PROG-IMT collaborative project. Lancet, in press.
33. Duivenvoorden R., Nederveen A.J., de Groot E., Kastelein J.J. Atherosclerosis imaging as a benchmark in the development of novel cardiovascular drugs. Curr Opin Lipidol 2007, 18:613-621.
34. Joannides R., Haefeli W.E., Linder L., et al. Nitric oxide is responsible for flow-dependent dilatation of human peripheral conduit arteries in vivo. Circulation 1995, 91:1314-1319.
35. Takase B., Uehata A., Akima T., et al. Endothelium-dependent flow-mediated vasodilation in coronary and brachial arteries in suspected coronary artery disease. Am J Cardiol 1998, 82:1535-1539.
36. Hirata Y., Nagata D., Suzuki E., Nishimatsu H., Suzuki J., Nagai R. Diagnosis and treatment of endothelial dysfunction in cardiovascular diseases. Int Heart J 2010, 51:1-6.
37. Corretti M.C., Anderson T.J., Benjamin E.J., et al. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the International Brachial Artery Reactivity Task Force. J Am Coll Cardiol 2002, 39:257-265.
38. Liu P.Y., Liu Y.W., Lin L.J., Chen J.H., Liao J.K. Evidence for statin pleiotropy in humans: differential effects of statins and ezetimibe on rho-associated coiled-coil containing protein kinase activity, endothelial function, and inflammation. Circulation 2009, 119:131-138.
39. Kureishi Y., Luo Z., Shiojima I., Bialik A., Fulton D., Lefer D.J. The HMG-CoA reductase inhibitor simvastatin activates the protein kinase Akt and promotes angiogenesis in normocholesterolemic animals. Nat Med 2000, 6:1004-1010.
40. Hillebrand U., Lang D., Telgmann R.G., et al. Nebivolol decreases endothelial cell stiffness via the estrogen receptor beta: a nano-imaging study. J Hypertens 2009, 27:517-526.
41. Kobayashi N., Mita S., Yoshida K., et al. Celiprolol activates eNOS through the PI3K-Akt pathway and inhibits VCAM-1 via NF-Kappa B induced by oxidative stress. Hypertension 2003, 42:1004-1013.
42. Warnholtz A., Ostad M.A., Heitzer T., et al. AT 1-receptor blockade with irbesartan improves peripheral but not coronary endothelial dysfunction in patients with stable coronary artery disease. Atherosclerosis 2007, 194:439-445.
43. Bahlmann F.H., de Groot K., Mueller O., Hertel B., Haller H., Fliser D. Stimulation of endothelial progenitor cells: a new putative therapeutic effect of angiotensin II receptor antagonists. Hypertension 2005, 45:526-529.
44. Schiffrin E.L., Park J.B., Pu Q. Effect of crossing over hypertensive patient from a beta-blocker to an angiotensin receptor antagonist on resistance artery structure and on endothelial function. J Hypertens 2002, 20:71-78.
45. Ziccardi P., Nappo F., Giugliano G., et al. Reduction of inflammatory cytokine concentrations and improvement of endothelial functions in obese women after weight loss over one year. Circulation 2002, 105:804-809.
46. Cuevas A.M., Irribarra V.L., Castillo O.A., Yañez M.D., Germain A.M. Isolated soy protein improves endothelial function in postmenopausal hypercholesterolemic women. Eur J Clin Nutr 2003, 57:889-894.
47. Agewall S., Wright S., Doughty R.N., Whalley G.A., Duxbury M., Sharpe N. Does a glass of red wine improve endothelial function?. Eur Heart J 2000, 21:74-78.
48. Rohani M., Agewall S. Oral snuff impairs endothelial function in healthy snuff users. J Intern Med 2004, 255:379-383.
49. Fathi R., Haluska B., Isbel N., Short L., Marwick T.H. The relative importance of vascular structure and function in predicting cardiovascular events. J Am Coll Cardiol 2004, 43:616-623.
50. Rossi R., Nuzzo A., Origliani G., Modena M.G. Prognostic role of flow-mediated dilation and cardiac risk factors in postmenopausal women. J Am Coll Cardiol 2008, 51:997-1002.
51. Brevetti G., Silvestro A., Schiano V., Chiariello M. Endothelial dysfunction and cardiovascular risk prediction in peripheral arterial disease: additive value of flow-mediated dilation to ankle-brachial pressure index. Circulation 2003, 108:2093-2098.
52. Gokce N., Keaney J.F., Hunter L.M., et al. Predictive value of noninvasively determined endothelial dysfunction for long-term cardiovascular events in patients with peripheral vascular disease. J Am Coll Cardiol 2003, 41:1769-1775.
53. Huang A.L., Silver A.E., Shvenke E., et al. Predictive value of reactive hyperemia for cardiovascular events in patients with peripheral arterial disease undergoing vascular surgery. Arterioscler Thromb Vasc Biol 2007, 27:2113-2119.
54. Chan S.Y., Mancini G.B., Kuramoto L., Schulzer M., Frohlich J., Ignaszewski A. The prognostic importance of endothelial dysfunction and carotid atheroma burden in patients with coronary artery disease. J Am Coll Cardiol 2003, 42:1037-1043.
55. Schmieder R.E., Messerli F.H. Hypertension and the heart. J Hum Hypertens 2000, 14:597-604.
56. McKay R.G., Pfeffer M.A., Pasternak R.C., et al. Left-ventricular remodeling after myocardial infarction-A corollary to infarct expansion. Circulation 1986, 74:693-702.
57. Lang R.M., Bierig M., Devereux R.B., et al. American Society of Echocardiography's Nomenclature and Standards Committee; Task Force on Chamber Quantification; American College of Cardiology Echocardiography Committee; American Heart Association; European Association of Echocardiography, European Society of Cardiology. Recommendations for chamber quantification. Eur J Echocardiogr 2006, 7:79-108.
58. Konstam M.A., Kronenberg M.W., Rousseau M.F., et al. Effects of the angiotensin converting enzyme inhibitor enalapril on the long-term progression of left ventricular dilatation in patients with asymptomatic systolic dysfunction. SOLVD (Studies of Left Ventricular Dysfunction) Investigators. Circulation 1993, 88:2277-2283.
59. Suzuki G., Morita H., Mishima T., et al. Effects of long-term monotherapy with eplerenone, a novel aldosterone blocker, on progression of left ventricular dysfunction and remodeling in dogs with heart failure. Circulation 2002, 106:2967-2972.
60. Sola S., Mir M.Q.S., Lerakis S., Tandon N., Khan B.V. Atorvastatin improves left ventricular systolic function and serum markers of inflammation in nonischemic heart failure. J Am Coll Cardiol 2006, 47:332-337.
61. Oldroyd K.G., Pye M.P., Ray S.G., et al. Effects of early captopril administration on infarct expansion, left ventricular remodeling and exercise capacity after acute myocardial infarction. Am J Cardiol 1991, 68:713-718.
62. Saxon L.A., De Marco T., Schafer J., Chatterjee K., Kumar U.N., Foster E. Effects of long-term biventricular stimulation for resynchronization on echocardiographic measures of remodeling. Circulation 2002, 105:1304-1310.
63. Sutton M.G.S., Plappert T., Abraham W.T., et al. Multicenter InSync Randomized Clinical Evaluation (MIRACLE) Study Group. Effect of cardiac resynchronization therapy on left ventricular size and function in chronic heart failure. Circulation 2003, 107:1985-1990.
64. Cohn J.N., Ferrari R., Sharpe N., Int Forum Cardiac R Cardiac remodeling-concepts and clinical implications: a consensus paper from an international forum on cardiac remodeling. J Am Coll Cardiol 2000, 35:569-582.
65. Kapetanakis S., Kearney M.T., Siva A., Gall N., Cooklin M., Monaghan M.J. Real-time three-dimensional echocardiography - a novel technique to quantify global left ventricular mechanical dyssynchrony. Circulation 2005, 112:992-1000.
66. Marsan N.A., Bleeker G.B., Ypenburg C., et al. Real-time three-dimensional echocardiography as a novel approach to assess left ventricular and left atrium reverse remodeling and to predict response to cardiac resynchronization therapy. Heart Rhythm 2008, 5:1257-1264.
67. Kramer C.M., Lima J.A.C., Reichek N., et al. Regional differences in function within noninfarcted myocardium during left ventricular remodeling. Circulation 1993, 88:1279-1288.
68. Tsutamoto T., Wada A., Maeda K., et al. Effect of spironolactone on plasma brain natriuretic peptide and left ventricular remodeling in patients with congestive heart failure. J Am Coll Cardiol 2001, 37:1228-1233.
69. Ganau A., Devereux R.B., Roman M.J., et al. Patterns of left ventricular hypertrophy and geometric remodeling in essential hypertension. J Am Coll Cardiol 1992, 19:1550-1558.
70. Wachtell K., Rokkedal J., Bella J.N., et al. Effect of electrocardiographic left ventricular hypertrophy on left ventricular systolic function in systemic hypertension (The LIFE Study). Losartan Intervention For Endpoint. Am J Cardiol 2001, 87:54-60.
71. Devereux R.B., Reichek N. Echocardiographic determination of left ventricular mass in man. Anatomic validation of the method. Circulation 1977, 55:613-618.
72. Mor-Avi V., Sugeng L., Weinert L., et al. Fast measurement of left ventricular mass with real-time three-dimensional echocardiography: comparison with magnetic resonance imaging. Circulation 2004, 110:1814-1818.
73. Levy D., Garrison R.J., Savage D.D., Kannel W.B., Castelli W.P. Prognostic implications of echocardiographically determined left ventricular mass in the Framingham Heart Study. N Engl J Med 1990, 322:1561-1566.
74. Klingbeil A.U., Schneider M., Martus P., Messerli F.H., Schmieder R.E. A meta-analysis of the effects of treatment on left ventricular mass in essential hypertension. Am J Med 2003, 115:41-46.
75. Devereux R.B., Palmieri V., Sharpe N., et al. Effects of once-daily angiotensin converting enzyme inhibition and calcium channel blockade-based antihypertensive treatment regimens on left ventricular hypertrophy and diastolic filling in hypertension. The Prospective Randomized Enalapril Study Evaluating Regression of Ventricular Enlargement (PRESERVE) trial. Circulation 2001, 104:1248-1254.
76. Thurmann P.A., Kenedi P., Schmidt A., Harder S., Rietbrock N. Influence of the angiotensin II antagonist valsartan on left ventricular hypertrophy in patients with essential hypertension. Circulation 1998, 98:2037-2042.
77. Devereux R.B., Dahlof B., Gerdts E., et al. Regression of hypertensive left ventricular hypertrophy by losartan compared with atenolol: the Losartan Intervention for Endpoint Reduction in Hypertension (LIFE) trial. Circulation 2004, 110:1456-1462.
78. Koren M.J., Ulin R.J., Koren A.T., Laragh J.H., Devereux R.B. Left ventricular mass change during treatment and outcome in patients with essential hypertension. Am J Hypertens 2002, 15:1021-1028.
79. Devereux R.B., Boman K., Gerdts E. Left ventricular mass change during treatment and outcome in hypertensive patients with left ventricular hypertrophy: the LIFE trial. J Am Coll Cardiol 2002, 39:464B. [Abstract].
80. Abhayaratna W.P., Seward J.B., Appleton C.P., et al. Left atrial size - physiologic determinants and clinical applications. J Am Coll Cardiol 2006, 47:2357-2363.
81. Yiu S.F., Enriquez-Sarano M., Tribouilloy C., Seward J.B., Tajik A.J. Determinants of the degree of functional mitral regurgitation in patients with systolic left ventricular dysfunction - a quantitative clinical study. Circulation 2000, 102:1400-1406.
82. Trichon B.H., Felker G.M., Shaw L.K., Cabell C.H., O'Connor C.M. Relation of frequency and severity of mitral regurgitation to survival among patients with left ventricular systolic dysfunction and heart failure. Am J Cardiol 2003, 91:538-543.
83. Nagueh S.F., Appleton C.P., Gillebert T.C., et al. Recommendations for the evaluation of left ventricular diastolic function by echocardiography. Eur J Echocardiogr 2009, 10:165-193.
84. Nagueh S.F., Appleton C.P., Gillebert T.C., et al. Recommendations for the evaluation of left ventricular diastolic function by echocardiography. J Am Soc Echocardiogr 2009, 22:107-133.
85. Blessberger H., Binder T. Non-invasive imaging: two dimensional speckle tracking echocardiography: basic principles. Heart 2010, 96:716-722.
86. Perez de Isla L., Balcones D.V., Fernandez-Golfin C., et al. Three-dimensional-wall motion tracking: a new and faster tool for myocardial strain assessment: comparison with two-dimensional-wall motion tracking. J Am Soc Echocardiogr 2009, 22:325-330.
87. Peng Y., Popovic Z.B., Sopko N., et al. Speckle tracking echocardiography in the assessment of mouse models of cardiac dysfunction. Am J Physiol Heart Circ Physiol 2009, 297:H811-H820.
88. Baur L.H., Schipperheyn J.J., van der Velde E.A., et al. Reproducibility of left ventricular size, shape and mass with echocardiography, magnetic resonance imaging and radionuclide angiography in patients with anterior wall infarction. A plea for core laboratories. Int J Card Imaging 1996, 12:233-240.
89. Otterstad J.E., Froeland G., St John Sutton M., Holme I. Accuracy and reproducibility of biplane two-dimensional echocardiographic measurements of left ventricular dimensions and function. Eur Heart J 1997, 18:507-513.
90. Wong M., Staszewsky L., Volpi A., Latini R., Barlera S., Höglund C. Quality assessment and quality control of echocardiographic performance in a large multicenter international study: valsartan in heart failure trial (Val-HeFT). J Am Soc Echocardiogr 2002, 15:293-301.
91. Galderisi M., Henein M.Y., D'hooge J., et al. European Association of Echocardiography. Recommendations of the European association of echocardiography: how to use echo-doppler in clinical trials: different modalities for different purposes. Eur J Echocardiogr 2011, 12:339-353.
92. Douglas P.S., DeCara J.M., Devereux R.B., et al. American Society of Echocardiography Standards; American College of Cardiology Foundation. Echocardiographic imaging in clinical trials: American Society of Echocardiography Standards for echocardiography core laboratories: endorsed by the American College of Cardiology Foundation. J Am Soc Echocardiogr 2009, 22:755-765.
93. Polonsky T.S., McClelland R.L., Jorgensen N.W., et al. Coronary artery calcium score and risk classification for coronary heart disease prediction. JAMA 2010, 303:1610-1616.
94. Oudkerk M., Stillman A.E., Halliburton S.S., et al. Coronary artery calcium screening: current status and recommendations from the European Society of Cardiac Radiology and North American Society for Cardiovascular Imaging. Eur Radiol 2008, 18:2785-2807.
95. Kronmal R.A., McClelland R.L., Detrano R., et al. Risk factors for the progression of coronary artery calcification in asymptomatic subjects: results from the Multi-Ethnic Study of Atherosclerosis (MESA). Circulation 2007, 115:2722-2730.
96. Callister T.Q., Raggi P., Cooil B., Lippolis N.J., Russo D.J. Effect of HMG-CoA reductase inhibitors on coronary artery disease as assessed by electron-beam computed tomography. N Engl J Med 1998, 339:1972-1978.
97. Achenbach S., Ropers D., Pohle K., et al. Influence of lipid-lowering therapy on the progression of coronary artery calcification: a prospective evaluation. Circulation 2002, 106:1077-1082.
98. McCullough P.A., Chinnaiyan K.M. Annual progression of coronary calcification in trials of preventive therapies. A systematic review. Arch Intern Med 2009, 169:2064-2070.
99. Perrone-Filardi P., Achenbach S., Möhlenkamp S., et al. Cardiac computed tomography and myocardial perfusion scintigraphy for risk stratification in asymptomatic individuals without known cardiovascular disease: a position statement of the Working Group on Nuclear Cardiology and Cardiac CT of the European Society of Cardiology. Eur Heart 2010, 32:1986-1993.
100. Hendel R.C., Berman D.S., Di Carli M.F., et al. ACCF/ASNC/ACR/AHA/ASE/SCCT/SCMR/SNM 2009 appropriate use criteria for cardiac radionuclide imaging: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, the American Society of Nuclear Cardiology, the American College of Radiology, the American Heart Association, the American Society of Echocardiography, the Society of Cardiovascular Computed Tomography, the Society for Cardiovascular Magnetic Resonance, and the Society of Nuclear Medicine: endorsed by the American College of Emergency Physicians. Circulation 2009, 119:561-587.
101. Gibbons R.J., Valeti U.S., Araoz P.A., Jaffe A.S. The quantification of infarct size. J Am Coll Cardiol 2004, 44:1533-1542.
102. Miller T.D., Sciagrà R., Gibbons R.J. Application of technetium-99m sestamibi single photon emission computed tomography in acute myocardial infarction: measuring the efficacy of therapy. Q J Nucl Med Mol Imaging 2010, 54:213-229.
103. Mahmarian J.J., Dakik H.A., Filipchuk N.G., et al. INSPIRE Investigators. An initial strategy of intensive medical therapy is comparable to that of coronary revascularization for suppression of scintigraphic ischemia in high-risk but stable survivors of acute myocardial infarction. J Am Coll Cardiol 2006, 48:2458-2467.
104. Shaw L.J., Berman D.S., Maron D.J., et al. COURAGE Investigators. Optimal medical therapy with or without percutaneous coronary intervention to reduce ischemic burden: results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial nuclear substudy. Circulation 2008, 117:1283-1291.
105. Iskandrian A.E., Garcia E.V., Faber T. Analysis of serial images: a challenge and an opportunity. J Nucl Cardiol 2008, 15:23-26.
106. Balu N., Yarnykh V.L., Scholnick J., Chu B., Yuan C., Hayes C. Improvements in carotid plaque imaging using a new eight-element phased array coil at 3T. J Magn Reson Imaging 2009, 30:1209-1214.
107. Koktzoglou I., Chung Y.C., Mani V., et al. Multislice dark-blood carotid artery wall imaging: a 1.5 T and 3.0 T comparison. J Magn Reson Imaging 2006, 23:699-705.
108. Underhill H.R., Yarnykh V.L., Hatsukami T.S., et al. Carotid plaque morphology and composition: initial comparison between 1.5- and 3.0-T magnetic field strengths. Radiology 2008, 248:550-560.
109. Oyama P., Gona C.J., Salton M.L., et al. Differential impact of age, sex, and hypertension on aortic atherosclerosis: the Framingham Heart Study. Arterioscler Thromb Vasc Biol 2008, 28:155-159.
110. Underhill H.R., Yuan C., Yarnykh V.L., et al. Predictors of surface disruption with MR imaging in asymptomatic carotid artery stenosis. Am J Neuroradiol 2010, 31:487-493.
111. Takaya N., Yuan C., Chu B., et al. Association between carotidplaque characteristics and subsequent ischemic cerebrovascular events: a prospective assessment with MRI: initial results. Stroke 2006, 37:818-823.
112. Altaf N., Daniels L., Morgan P.S., et al. Detection of intraplaque hemorrhage by magnetic resonance imaging insymptomatic patients with mild to moderate carotid stenosis predicts recurrent neurological events. J Vasc Surg 2008, 47:337-342.
113. Corti R., Fayad Z.A., Fuster V., et al. Effects of lipid-lowering by simvastatin on human atherosclerotic lesions: a longitudinal study by high-resolution, non-invasive magnetic resonance imaging. Circulation 2001, 104:249-252.
114. Corti R., Fuster V., Fayad Z.A., et al. Lipid lowering by simvastatin induces regression of human atherosclerotic lesions: two years' followup by highresolution non-invasive magnetic resonance imaging. Circulation 2002, 106:2884-2887.
115. Lima J.A., Desai M.Y., Steen H., Warren W.P., Gautam S., Lai S. Statin-induced cholesterol lowering and plaque regression after 6 months of magnetic resonance imaging-monitored therapy. Circulation 2004, 110:2336-2341.
116. Lee J.M., Wiesmann F., Shirodaria C., et al. Early changes in arterial structure and function following statin initiation: quantification by magnetic resonance imaging. Atherosclerosis 2008, 197:951-958.
117. Underhill H.R., Yuan C., Zhao X.Q., et al. Effect of rosuvastatin therapy on carotid plaque morphology and composition in moderately hypercholesterolemic patients: a highresolution magnetic resonance imaging trial. Am Heart J 2008, 155:1-8.
118. Ayaori M., Momiyama Y., Fayad Z.A., et al. Effect of bezafibrate therapy on atherosclerotic aortic plaques detected by MRI in dyslipidemic patients with hypertriglyceridemia. Atherosclerosis 2008, 196:425-433.
119. Lee J.M., Robson M.D., Yu L.M., et al. Effects of high-dose modified-release nicotinic acid on atherosclerosis and vascular function: a randomized, placebo-controlled, magnetic resonance imaging study. J Am Coll Cardiol 2009, 54:1787-1794.
120. Weir R.A., Mark P.B., Petrie C.J., et al. Left ventricular remodeling after acute myocardial infarction: does eplerenone have an effect?. Am Heart J 2009, 157:1088-1096.
121. Desch S., Eitel I., de Waha S., et al. Cardiac magnetic resonance imaging parameters as surrogate endpoints in clinical trials of acute myocardial infarction. Trials 2011, 12:204.