title: 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.
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.
authors.affiliation: Erasmus Medical Center, Thoraxcenter, Rotterdam, The Netherlands.
authors.forename: Carlos A G
authors.initials: CA
authors.lastname: Van Mieghem
authors.forename: Nico
authors.initials: N
authors.lastname: Bruining
authors.forename: Johannes A
authors.initials: JA
authors.lastname: Schaar
authors.forename: Eugene
authors.initials: E
authors.lastname: McFadden
authors.forename: Nico
authors.initials: N
authors.lastname: Mollet
authors.forename: Filippo
authors.initials: F
authors.lastname: Cademartiri
authors.forename: Frits
authors.initials: F
authors.lastname: Mastik
authors.forename: Jurgen M R
authors.initials: JM
authors.lastname: Ligthart
authors.forename: Gaston A Rodriguez
authors.initials: GA
authors.lastname: Granillo
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.forename: Georgios
authors.initials: G
authors.lastname: Sianos
authors.forename: Willem J
authors.initials: WJ
authors.lastname: van der Giessen
authors.forename: Bianca
authors.initials: B
authors.lastname: Backx
authors.forename: Marie-Angele M
authors.initials: MA
authors.lastname: Morel
authors.forename: Gerrit-Anne
authors.initials: GA
authors.lastname: Van Es
authors.forename: Jonathon D
authors.initials: JD
authors.lastname: Sawyer
authors.forename: June
authors.initials: J
authors.lastname: Kaplow
authors.forename: Andrew
authors.initials: A
authors.lastname: Zalewski
authors.forename: Anton F W
authors.initials: AF
authors.lastname: van der Steen
authors.forename: Pim
authors.initials: P
authors.lastname: de Feyter
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D000328:Adult; D015906:Angioplasty, Balloon, Coronary; D015415:Biomarkers / Q000097:blood*; D002097:C-Reactive Protein / Q000378:metabolism; D018932:Chemokine CCL2 / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D017023:Coronary Angiography; D001026:Coronary Artery Bypass; D003324:Coronary Artery Disease / Q000097:blood* / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000628:therapy; D003326:Coronary Circulation; D005500:Follow-Up Studies; D006801:Humans; D007090:Image Interpretation, Computer-Assisted; D007091:Image Processing, Computer-Assisted; D015850:Interleukin-6 / Q000097:blood; D020780:Matrix Metalloproteinase 9 / Q000097:blood; D009426:Netherlands; D011446:Prospective Studies; D012107:Research Design; D012680:Sensitivity and Specificity; D036542:Tomography, Spiral Computed; D014409:Tumor Necrosis Factor-alpha / Q000378:metabolism; D018084:Ultrasonography, Interventional
chemical_list: D015415:Biomarkers; D018932:Chemokine CCL2; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D015850:Interleukin-6; D014409:Tumor Necrosis Factor-alpha; D002097:C-Reactive Protein; D020780:Matrix Metalloproteinase 9