Individual progression of carotid intima media thickness as a surrogate for vascular risk (PROG-IMT): Rationale and design of a meta-analysis project - 05/08/11

Doi : 10.1016/j.ahj.2010.02.008

Matthias W. Lorenz, MD ^a,^⁎ , Horst Bickel, MD, PhD ^b, Michiel L. Bots, PhD ^c,^d, Monique M.B. Breteler, PhD ^d, Alberico L. Catapano, PhD ^e, Moise Desvarieux, PhD ^f, Bo Hedblad, PhD ^g, Bernhard Iglseder, MD ^h, Stein Harald Johnsen, MD, PhD ^i,^l, Michal Juraska, DSc ^j, Stefan Kiechl, MD ^k, Ellisiv B. Mathiesen, MD, PhD ^i,^l, Giuseppe D. Norata, PhD ^e, Liliana Grigore, PhD ^e, Joseph Polak, MD ^m, Holger Poppert, MD, PhD ⁿ, Maria Rosvall, MD, PhD ^o, Tatjana Rundek, MD, PhD ^p, Ralph L. Sacco, MD ^p, Dirk Sander, MD ^n,^q, Matthias Sitzer, MD ^a,^r, Helmuth Steinmetz, MD ^a, Eva Stensland, MD, PhD ^i,^l, Johann Willeit, MD ^k, Jacqueline Witteman, PhD ^d, David Yanez, PhD ^j, Simon G. Thompson, DSc ^s
The PROG-IMT Study Group^{^t}
See Appendix online for a complete listing of The PROG-IMT Study Group.
^a Department of Neurology, University Hospital, Goethe-University, Frankfurt am Main, Germany
^b Department of Psychiatry, University Hospital of the Technische Universitaet, Munich, Germany
^c Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands
^d Department of Epidemiology and Biostatistics, Erasmus Medical Center, Rotterdam, The Netherlands
^e Department of Pharmacological Sciences, University of Milan, Milan, Italy and SISA Center for the Study of Atherosclerosis, Bassini Hospital, Cinisello Balsamo, Italy
^f Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY
^g Department of Clinical Sciences in Malmö, Epidemiological Research Group, Lund University, Malmö University Hospital, Malmö, Sweden
^h Department of Neurology, Christian Doppler Klinik, Department of Geriatrics, Parcelsus Medical University, Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaft mbH, Salzburg, Austria
ⁱ Department of Neurology, University Hospital of Northern Norway, Tromsø, Norway
^j Department of Biostatistics, University of Washington, Seattle, WA
^k Department of Neurology, Medical University Innsbruck, Innsbruck, Austria
^l Department of Neurology, Institute of Clinical Medicine, University of Tromsø, Tromsø, Norway
^m Tufts University School of Medicine, Tufts Medical Center, Boston, MA
ⁿ Department of Neurology, University Hospital of the Technische Universitaet, Munich, Germany
^o Department of Community Medicine, Lund University, Malmö University Hospital, Malmö, Sweden
^p Department of Neurology, Miller School of Medicine, University of Miami, Miami, FL
^q Department of Neurology, Medical Park Hospital, Bischofswiesen, Germany
^r Department of Neurology, Klinikum Herford, Herford, Germany
^s MRC Biostatistics Unit, Cambridge, United Kingdom

^⁎Reprint requests: Matthias W. Lorenz, MD, Department of Neurology, Goethe-University Frankfurt am Main, Schleusenweg 2-16, D-60528 Frankfurt/Main, Germany.

Résumé

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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Plan

The PROG-IMT project

Objectives

Three stages of the project

Search strategy

Selection bias

Individual patient data

Inclusion of studies

Expected number of eligible studies

Analysis strategy for stage 1

Statistical calculations

Analysis strategy for stage 2

Analysis strategy for stage 3

Summary

Disclosures

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Vol 159 - N° 5

P. 730 - mai 2010 Retour au numéro

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Individual progression of carotid intima media thickness as a surrogate for vascular risk (PROG-IMT): Rationale and design of a meta-analysis project - 05/08/11

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