J Neurol (2011) 258:795–803 DOI 10.1007/s00415-010-5841-8 O R I G I N A L C O M M U N I C A T I O N Design, data management, and population baseline characteristics of the PERFORM magnetic resonance imaging project P. Maeder • L. Bracoud • H. Chabriat • A. Gass • P. Michel • M. Hennerici Received: 12 August 2010 / Revised: 22 October 2010 / Accepted: 15 November 2010 / Published online: 3 December 2010 The Author(s) 2010. This article is published with open access at Springerlink.com Abstract Quantitative information from magnetic reso- nance imaging (MRI) may substantiate clinical ﬁndings and provide additional insight into the mechanism of clinical interventions in therapeutic stroke trials. The PERFORM study is exploring the efﬁcacy of terutroban versus aspirin for secondary prevention in patients with a history of ischemic stroke. We report on the design of an exploratory longitudinal MRI follow-up study that was performed in a subgroup of the PERFORM trial. An international multi- centre longitudinal follow-up MRI study was designed for different MR systems employing safety and efﬁcacy read- outs: new T2 lesions, new DWI lesions, whole brain volume change, hippocampal volume change, changes in tissue microstructure as depicted by mean diffusivity and On behalf of the PERFORM Study Investigators. Investigators are listed in Appendix. PERFORM: Prevention of cerebrovascular and cardiovascular Events of ischemic origin with teRutroban in patients with a history oF ischemic strOke or tRansient ischeMic attack. P. Maeder (&) Centre Hospitalier Universitaire Vaudois, Service de Radiologie, Rue du Bugnon 47, 1011 Lausanne, Switzerland e-mail: philippe.maeder@chuv.ch L. Bracoud BioClinica, Lyon, France e-mail: luc.bracoud@bioclinica.com H. Chabriat Hoˆpital Lariboisie`re, Service de Neurologie, Paris, France e-mail: hugues.chabriat@lrb.ap-hop-paris.fr A. Gass M. Hennerici Department of Neurology, University of Heidelberg, Mannheim, Germany fractional anisotropy, vessel patency on MR angiography, and the presence of and development of new microbleeds. A total of 1,056 patients (men and women C55 years) were included. The data analysis included 3D reformation, image registration of different contrasts, tissue segmentation, and automated lesion detection. This large international multi- centre study demonstrates how new MRI readouts can be used to provide key information on the evolution of cerebral tissue lesions and within the macrovasculature after ather- othrombotic stroke in a large sample of patients. Keywords MRI Lesion load Brain atrophy Microbleeds PERFORM Longitudinal brain disease progression Introduction During the last 20 years, novel magnetic resonance imaging (MRI) techniques have emerged that allow the non-invasive M. Hennerici e-mail: hennerici@neuro.ma.uni-heidelberg.de A. Gass Department of Neurology, University Hospital Basel, Basel, Switzerland e-mail: AGass@uhbs.ch P. Michel Centre Hospitalier Universitaire Vaudois, Service de Neurologie, Rue du Bugnon 47, 1011 Lausanne, Switzerland e-mail: patrik.michel@chuv.ch 123