Carotid intima media thickness (IMT) progression is increasingly used as a surrogate for vascular risk. This use is supported by data from a few clinical trials investigating statins, but established criteria of surrogacy are only partially fulfilled. To provide a valid basis for the use of IMT progression as a study end point, we are performing a 3-step meta-analysis project based on individual participant data. Objectives of the 3 successive stages are to investigate (1) whether IMT progression prospectively predicts myocardial infarction, stroke, or death in population-based samples; (2) whether it does so in prevalent disease cohorts; and (3) whether interventions affecting IMT progression predict a therapeutic effect on clinical end points. Recruitment strategies, inclusion criteria, and estimates of the expected numbers of eligible studies are presented along with a detailed analysis plan.
Individual progression of carotid intima media thickness as a surrogate for vascular risk (PROG-IMT) : rationale and design of a meta-analysis project / M. W. Lorenz, H. Bickel, M.L. Bots, M.M. Breteler, A.L. Catapano, M. Desvarieux, B. Hedblad, B. Iglseder, S.H. Johnsen, M. Juraska, S. Kiechl, E.B. Mathiesen, G.D. Norata, L. Grigore, J. Polak, H. Poppert, M. Rosvall, T. Rundek, R.L. Sacco, D. Sander, M. Sitzer, H. Steinmetz, E. Stensland, J. Willeit, J. Witteman, D. Yanez, S.G. Thompson, PROG-IMT Study Group. - In: AMERICAN HEART JOURNAL. - ISSN 0002-8703. - 159:5(2010 May), pp. 730-736e.2. [10.1016/j.ahj.2010.02.008]
Individual progression of carotid intima media thickness as a surrogate for vascular risk (PROG-IMT) : rationale and design of a meta-analysis project
A.L. Catapano;G.D. Norata;
2010
Abstract
Carotid intima media thickness (IMT) progression is increasingly used as a surrogate for vascular risk. This use is supported by data from a few clinical trials investigating statins, but established criteria of surrogacy are only partially fulfilled. To provide a valid basis for the use of IMT progression as a study end point, we are performing a 3-step meta-analysis project based on individual participant data. Objectives of the 3 successive stages are to investigate (1) whether IMT progression prospectively predicts myocardial infarction, stroke, or death in population-based samples; (2) whether it does so in prevalent disease cohorts; and (3) whether interventions affecting IMT progression predict a therapeutic effect on clinical end points. Recruitment strategies, inclusion criteria, and estimates of the expected numbers of eligible studies are presented along with a detailed analysis plan.
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