Stroke. 2003;34:2985-2994
Published online before print November 13, 2003, doi: 10.1161/01.STR.0000102044.27905.B5
Published online before print November 13, 2003, doi: 10.1161/01.STR.0000102044.27905.B5
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
(Stroke. 2003;34:2985.)
© 2003 American Heart Association, Inc.
Comments, Opinions, and Reviews |
Carotid Intima-Media Thickness Measurements in Intervention Studies
Design Options, Progression Rates, and Sample Size Considerations: A Point of View
From the Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands (M.L.B., D.E.G.); and Departments of Public Health Sciences (G.W.E.) and Neurology (W.A.R.), Wake Forest University School of Medicine, Winston-Salem, NC.
Correspondence to Michiel L. Bots, MD, PhD, Julius Center for Health Sciences and Primary Care University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands. E-mail m.l.bots{at}jc.azu.nl
Background— Carotid intima-media thickness (CIMT) measurements are currently widely used in randomized controlled trials (RCTs) to study the efficacy of interventions. In designing a RCT with CIMT as a primary outcome, several ultrasound options may be considered. We discuss the various options and provide a pooled estimate of CIMT progression. In addition, we quantify the effect of these choices on the sample size for a RCT.
Summary of Comment— To estimate the average CIMT progression rate, we performed a pooled analysis using CIMT progression rates of control groups from published RCTs. The pros and cons of the following ultrasound options are discussed: which arterial segments may be studied; whether near and far wall CIMT measurements should be performed; whether a single image (1 angle of interrogation) or multiple images (more angles of interrogation) should be used; whether a manual or an automated edge detection reading system should be used; and whether images should be read in a random fashion or in batches. The pooled analysis showed an annual rate of change in mean common CIMT of 0.0147 mm (95% CI, 0.0122 to 0.0173) and in mean maximum CIMT of 0.0176 mm (95% CI, 0.0149 to 0.0203).
Conclusions— Given the current evidence together with our experience with recently developed ultrasound protocols, we favor the use of mean maximum CIMT rather than mean common CIMT as the primary outcome measure in RCTs designed to evaluate the efficacy of pharmacological and nonpharmacological interventions in carotid artery atherosclerosis.
Key Words: atherosclerosis • carotid arteries • intima-media thickness • preventive medicine • randomized controlled trials
This article has been cited by other articles:
 |
|
 |
|
  E. M. Urbina, R. V. Williams, B. S. Alpert, R. T. Collins, S. R. Daniels, L. Hayman, M. Jacobson, L. Mahoney, M. Mietus-Snyder, A. Rocchini, et al. Noninvasive Assessment of Subclinical Atherosclerosis in Children and Adolescents: Recommendations for Standard Assessment for Clinical Research: A Scientific Statement From the American Heart Association Hypertension, November 1, 2009; 54(5): 919 - 950. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A L. Gould, J. Koglin, R. P Bain, C.-A. Pinto, Y. B Mitchel, R. C Pasternak, and A. Sapre Effects of sources of variability on sample sizes required for RCTs, applied to trials of lipid-altering therapies on carotid artery intima-media thickness Clinical Trials, August 1, 2009; 6(4): 305 - 319. [Abstract] [PDF]
|
|
|
|
 |
|
 E. M. Lonn, H. C. Gerstein, P. Sheridan, S. Smith, R. Diaz, V. Mohan, J. Bosch, S. Yusuf, G. R. Dagenais, and DREAM (Diabetes REduction Assessment with ramipril Effect of Ramipril and of Rosiglitazone on Carotid Intima-Media Thickness in People With Impaired Glucose Tolerance or Impaired Fasting Glucose STARR (STudy of Atherosclerosis with Ramipril and Rosiglitazone). J. Am. Coll. Cardiol., June 2, 2009; 53(22): 2028 - 2035. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. Bo, L. Corsinovi, A. Brescianini, A. Sona, M. Astengo, R. Dumitrache, M. F. Ferrio, L. Pricop, and G. Fonte High-Sensitivity C-Reactive Protein Is Not Independently Associated With Peripheral Subclinical Atherosclerosis Angiology, February 1, 2009; 60(1): 12 - 20. [Abstract] [PDF]
|
|
|
|
 |
|
 J. D. Spence Is Carotid Intima-Media Thickness a Reliable Clinical Predictor? Mayo Clin. Proc., November 1, 2008; 83(11): 1299 - 1300. [Full Text] [PDF]
|
|
|
|
 |
|
 M. Egger, A. Krasinski, B. K. Rutt, A. Fenster, and G. Parraga Comparison of B-Mode Ultrasound, 3-Dimensional Ultrasound, and Magnetic Resonance Imaging Measurements of Carotid Atherosclerosis J. Ultrasound Med., September 1, 2008; 27(9): 1321 - 1334. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
F. Faita, V. Gemignani, E. Bianchini, C. Giannarelli, L. Ghiadoni, and M. Demi Real-time Measurement System for Evaluation of the Carotid Intima-Media Thickness With a Robust Edge Operator J. Ultrasound Med., September 1, 2008; 27(9): 1353 - 1361. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. H. O'Keefe, K. A. Bybee, and C. J. Lavie Intensive Lipid Intervention in the Post-ENHANCE Era Mayo Clin. Proc., August 1, 2008; 83(8): 867 - 869. [Full Text] [PDF]
|
|
|
|
 |
|
 D. Steinberg, E. J. Eichhorn, W. E. Connor, G. A. Diamond, S. Kaul, J. A. Blake, H. R. Davis Jr., N. J. Murgolo, M. P. Graziano, T. Kaye, et al. Simvastatin with or without ezetimibe in familial hypercholesterolemia. N. Engl. J. Med., July 31, 2008; 359(5): 529 - 530. [Full Text] [PDF]
|
|
|
|
 |
|
 J. Gonzalez, J. C. Wood, F. J. Dorey, T. A. L. Wren, and V. Gilsanz Reproducibility of Carotid Intima-Media Thickness Measurements in Young Adults Radiology, May 1, 2008; 247(2): 465 - 471. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. Puato, P. Palatini, M. Zanardo, F. Dorigatti, C. Tirrito, M. Rattazzi, and P. Pauletto Increase in Carotid Intima-Media Thickness in Grade I Hypertensive Subjects: White-Coat Versus Sustained Hypertension Hypertension, May 1, 2008; 51(5): 1300 - 1305. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 D. K. Kim, H. J. Kim, S. H. Han, J. E. Lee, S. J. Moon, B. S. Kim, S.-W. Kang, K. H. Choi, H. Y. Lee, and D.-S. Han Chlamydia pneumoniae accompanied by inflammation is associated with the progression of atherosclerosis in CAPD patients: a prospective study for 3 years Nephrol. Dial. Transplant., March 1, 2008; 23(3): 1011 - 1018. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. Tatasciore, G. Renda, M. Zimarino, M. Soccio, G. Bilo, G. Parati, G. Schillaci, and R. De Caterina Awake Systolic Blood Pressure Variability Correlates With Target-Organ Damage in Hypertensive Subjects Hypertension, August 1, 2007; 50(2): 325 - 332. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. J.P. Kastelein, S. I. van Leuven, L. Burgess, G. W. Evans, J. A. Kuivenhoven, P. J. Barter, J. H. Revkin, D. E. Grobbee, W. A. Riley, C. L. Shear, et al. Effect of Torcetrapib on Carotid Atherosclerosis in Familial Hypercholesterolemia N. Engl. J. Med., April 19, 2007; 356(16): 1620 - 1630. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. R. Crouse III, J. S. Raichlen, W. A. Riley, G. W. Evans, M. K. Palmer, D. H. O'Leary, D. E. Grobbee, M. L. Bots, and for the METEOR Study Group Effect of Rosuvastatin on Progression of Carotid Intima-Media Thickness in Low-Risk Individuals With Subclinical Atherosclerosis: The METEOR Trial JAMA, March 28, 2007; 297(12): 1344 - 1353. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
T. Mazzone, P. M. Meyer, S. B. Feinstein, M. H. Davidson, G. T. Kondos, R. B. D'Agostino Sr, A. Perez, J.-C. Provost, and S. M. Haffner Effect of Pioglitazone Compared With Glimepiride on Carotid Intima-Media Thickness in Type 2 Diabetes: A Randomized Trial JAMA, December 6, 2006; 296(21): 2572 - 2581. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. A. Meyer, G. Kundt, U. Lenschow, P. Schuff-Werner, and W. Kienast Improvement of Early Vascular Changes and Cardiovascular Risk Factors in Obese Children After a Six-Month Exercise Program J. Am. Coll. Cardiol., November 7, 2006; 48(9): 1865 - 1870. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 H. Yokoyama, N. Katakami, and Y. Yamasaki Recent Advances of Intervention to Inhibit Progression of Carotid Intima-Media Thickness in Patients With Type 2 Diabetes Mellitus Stroke, September 1, 2006; 37(9): 2420 - 2427. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. D. Spence Measuring Effects of Antiatherosclerotic Therapies J. Am. Coll. Cardiol., August 15, 2006; 48(4): 845 - 846. [Full Text] [PDF]
|
|
|
|
 |
|
 J. M. Dijk, Y. van der Graaf, M. L. Bots, D. E. Grobbee, A. Algra, and on behalf of the SMART study group Carotid intima-media thickness and the risk of new vascular events in patients with manifest atherosclerotic disease: the SMART study Eur. Heart J., August 2, 2006; 27(16): 1971 - 1978. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. R. Crouse III Thematic review series: Patient-Oriented Research. Imaging atherosclerosis: state of the art J. Lipid Res., August 1, 2006; 47(8): 1677 - 1699. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. L. Bots, G. W. Evans, W. Riley, K. H. McBride, E. D. Paskett, F. A. Helmond, D. E. Grobbee, and for the OPAL Investigators The effect of tibolone and continuous combined conjugated equine oestrogens plus medroxyprogesterone acetate on progression of carotid intima-media thickness: the Osteoporosis Prevention and Arterial effects of tiboLone (OPAL) study Eur. Heart J., March 2, 2006; 27(6): 746 - 755. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
C. D. Ainsworth, C. C. Blake, A. Tamayo, V. Beletsky, A. Fenster, and J. D. Spence 3D Ultrasound Measurement of Change in Carotid Plaque Volume: A Tool for Rapid Evaluation of New Therapies Stroke, September 1, 2005; 36(9): 1904 - 1909. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. Pfutzner, N. Marx, G. Lubben, M. Langenfeld, D. Walcher, T. Konrad, and T. Forst Improvement of Cardiovascular Risk Markers by Pioglitazone Is Independent From Glycemic Control: Results From the Pioneer Study J. Am. Coll. Cardiol., June 21, 2005; 45(12): 1925 - 1931. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M.R. Langenfeld, T. Forst, C. Hohberg, P. Kann, G. Lubben, T. Konrad, S.D. Fullert, C. Sachara, and A. Pfutzner Pioglitazone Decreases Carotid Intima-Media Thickness Independently of Glycemic Control in Patients With Type 2 Diabetes Mellitus: Results From a Controlled Randomized Study Circulation, May 17, 2005; 111(19): 2525 - 2531. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. L. Bots, D. E. Grobbee, A. Hofman, and J. C.M. Witteman Common Carotid Intima-Media Thickness and Risk of Acute Myocardial Infarction: The Role of Lumen Diameter Stroke, April 1, 2005; 36(4): 762 - 767. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
F. W. Asselbergs, A. M. van Roon, H. L. Hillege, P. E. de Jong, R. O.B. Gans, A. J. Smit, W. H. van Gilst, and on behalf of the PREVEND IT Investigators Effects of Fosinopril and Pravastatin on Carotid Intima-Media Thickness in Subjects With Increased Albuminuria Stroke, March 1, 2005; 36(3): 649 - 653. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 E. D. Beishuizen, M. A. van de Ree, J. W. Jukema, J. T. Tamsma, J. C. M. van der Vijver, A. E. Meinders, H. Putter, and M. V. Huisman Two-Year Statin Therapy Does Not Alter the Progression of Intima-Media Thickness in Patients With Type 2 Diabetes Without Manifest Cardiovascular Disease Diabetes Care, December 1, 2004; 27(12): 2887 - 2892. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M.L. Eigenbrodt, Z. Bursac, E.P. Eigenbrodt, D.J. Couper, R.E. Tracy, and J.L. Mehta Mathematical estimation of the potential effect of vascular remodelling/dilatation on B-mode ultrasound intima-medial thickness QJM, November 1, 2004; 97(11): 729 - 737. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. D. Mackinnon, P. Jerrard-Dunne, M. Sitzer, A. Buehler, S. von Kegler, and H. S. Markus Rates and Determinants of Site-Specific Progression of Carotid Artery Intima-Media Thickness: The Carotid Atherosclerosis Progression Study Stroke, September 1, 2004; 35(9): 2150 - 2154. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. Zureik, P. Galan, S. Bertrais, L. Mennen, S. Czernichow, J. Blacher, P. Ducimetiere, and S. Hercberg Effects of Long-Term Daily Low-Dose Supplementation With Antioxidant Vitamins and Minerals on Structure and Function of Large Arteries Arterioscler Thromb Vasc Biol, August 1, 2004; 24(8): 1485 - 1491. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. D. Spence and M. L. Bots Ultrasound Measurement of Atherosclerosis * Response: Carotid Intima-Media Thickness Measurements in Intervention Studies Stroke, May 1, 2004; 35(5): e87 - e88. [Full Text] [PDF]
|
|