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Rationale and methods of the integrated biomarker and imaging study (IBIS): combining invasive and non-invasive imaging with biomarkers to detect subclinical atherosclerosis and assess coronary lesion biology

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Abstract

Death or myocardial infarction, the most serious clinical consequences of atherosclerosis, often result from plaque rupture at non-flow limiting lesions. Current diagnostic imaging with coronary angiography only detects large plaques that already impinge on the lumen and cannot accurately identify those that have a propensity to cause unheralded events. Accurate evaluation of the composition or of the biomechanical characteristics of plaques with invasive or non-invasive methods, alone or in conjunction with assessment of circulating biomarkers, could help identify high-risk patients, thus providing the rationale for aggressive treatments in order to reduce future clinical events. The IBIS (Integrated Biomarker and Imaging Study) study is a prospective, single-center, non-randomized, observational study conducted in Rotterdam. The aim of the IBIS study is to evaluate both invasive (quantitative coronary angiography, intravascular ultrasound (IVUS) and palpography) and non-invasive (multislice spiral computed tomography) imaging techniques to characterize non-flow limiting coronary lesions. In addition, multiple classical and novel biomarkers will be measured and their levels correlated with the results of the different imaging techniques. A minimum of 85 patients up to a maximum of 120 patients will be included. This paper describes the study protocol and methodological solutions that have been devised for the purpose of comparisons among several imaging modalities. It outlines the analyses that will be performed to compare invasive and non-invasive imaging techniques in conjunction with multiple biomarkers to characterize non-flow limiting subclinical coronary lesions.

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Abbreviations

EEM:

external elastic membrane

HU:

Hounsfield units

IVUS:

intravascular ultrasound

MSCT:

multislice spiral computed tomography

PCI:

percutaneous coronary intervention

QCU:

Quantitative Coronary Ultrasound

RF:

radio frequency

ROI:

region of interest

STEMI:

ST elevation myocardial infarction

US:

ultrasound

VH:

virtual histology

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Authors and Affiliations

  1. Erasmus Medical Center, Thoraxcenter Bd 404, Dr Molewaterplein 40, 3015, GD, Rotterdam, The Netherlands

    Carlos A. G. Van. Mieghem, Nico Bruining, Eugene McFadden, Nico Mollet, Filippo Cademartiri, Jurgen M. R. Ligthart, Gaston A. Rodriguez. Granillo, Marco Valgimigli, Georgios Sianos, Willem J. van der. Giessen, Pim de Feyter & Patrick W. Serruys

  2. Interuniversity Cardiology Institute of the Netherlands, Utrecht, the Netherlands

    Johannes A. Schaar, Frits Mastik & Anton F. W. vander. Steen

  3. GlaxoSmithKline, Philadelphia, PA, USA

    Jonathon D. Sawyer, June Kaplow & Andrew Zalewski

  4. Cardialysis, Rottterdam, The Netherlands

    Bianca Backx, Marie-Angele M. Morel & Gerrit-Anne Van Es

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  1. Carlos A. G. Van. Mieghem
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  2. Nico Bruining
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  3. Johannes A. Schaar
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Correspondence to Patrick W. Serruys.

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Mieghem, C.A.G.V., Bruining, N., Schaar, J.A. et al. Rationale and methods of the integrated biomarker and imaging study (IBIS): combining invasive and non-invasive imaging with biomarkers to detect subclinical atherosclerosis and assess coronary lesion biology. Int J Cardiovasc Imaging 21, 425–441 (2005). https://doi.org/10.1007/s10554-004-7986-y

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