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Comparative assessment of image quality for coronary CT angiography with iobitridol and two contrast agents with higher iodine concentrations: iopromide and iomeprol. A multicentre randomized double-blind trial

Objectives To demonstrate non-inferiority of iobitridol 350 for coronary CT angiography (CTA) compared to higher iodine content contrast media regarding rate of patients evaluable for the presence of coronary artery stenoses. Methods In this multicentre trial, 452 patients were randomized to receive...

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Published in:European radiology 2017-02, Vol.27 (2), p.821-830
Main Authors: Achenbach, Stephan, Paul, Jean-François, Laurent, François, Becker, Hans-Christoph, Rengo, Marco, Caudron, Jerome, Leschka, Sebastian, Vignaux, Olivier, Knobloch, Gesine, Benea, Giorgio, Schlosser, Thomas, Andreu, Jordi, Cabeza, Beatriz, Jacquier, Alexis, Souto, Miguel, Revel, Didier, Qanadli, Salah Dine, Cademartiri, Filippo
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cited_by cdi_FETCH-LOGICAL-c503t-72950ffd2c8c3fd3fbaa2bae1ecfc7871b912df07223d33fdf4e8c449bbd738c3
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container_title European radiology
container_volume 27
creator Achenbach, Stephan
Paul, Jean-François
Laurent, François
Becker, Hans-Christoph
Rengo, Marco
Caudron, Jerome
Leschka, Sebastian
Vignaux, Olivier
Knobloch, Gesine
Benea, Giorgio
Schlosser, Thomas
Andreu, Jordi
Cabeza, Beatriz
Jacquier, Alexis
Souto, Miguel
Revel, Didier
Qanadli, Salah Dine
Cademartiri, Filippo
description Objectives To demonstrate non-inferiority of iobitridol 350 for coronary CT angiography (CTA) compared to higher iodine content contrast media regarding rate of patients evaluable for the presence of coronary artery stenoses. Methods In this multicentre trial, 452 patients were randomized to receive iobitridol 350, iopromide 370 or iomeprol 400 and underwent coronary CTA using CT systems with 64-detector rows or more. Two core lab readers assessed 18 coronary segments per patient regarding image quality (score 0 = non diagnostic to 4 = excellent quality), vascular attenuation, signal and contrast to noise ratio (SNR, CNR). Patients were considered evaluable if no segment had a score of 0. Results Per-patient, the rate of fully evaluable CT scans was 92.1, 95.4 and 94.6 % for iobitridol, iopromide and iomeprol, respectively. Non-inferiority of iobitridol over the best comparator was demonstrated with a 95 % CI of the difference of [-8.8 to 2.1], with a pre-specified non-inferiority margin of -10 %. Although average attenuation increased with higher iodine concentrations, average SNR and CNR did not differ between groups. Conclusions With current CT technology, iobitridol 350 mg iodine/ml is not inferior to contrast media with higher iodine concentrations in terms of image quality for coronary stenosis assessment. Key Points • Iodine concentration is an important parameter for image quality in coronary CTA. • Contrast enhancement must be balanced against the amount of iodine injected. • Iobitridol 350 is non-inferior compared to CM with higher iodine concentrations. • Higher attenuation with higher iodine concentrations, but no SNR or CNR differences.
doi_str_mv 10.1007/s00330-016-4437-9
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A multicentre randomized double-blind trial</title><source>Springer Nature</source><creator>Achenbach, Stephan ; Paul, Jean-François ; Laurent, François ; Becker, Hans-Christoph ; Rengo, Marco ; Caudron, Jerome ; Leschka, Sebastian ; Vignaux, Olivier ; Knobloch, Gesine ; Benea, Giorgio ; Schlosser, Thomas ; Andreu, Jordi ; Cabeza, Beatriz ; Jacquier, Alexis ; Souto, Miguel ; Revel, Didier ; Qanadli, Salah Dine ; Cademartiri, Filippo</creator><creatorcontrib>Achenbach, Stephan ; Paul, Jean-François ; Laurent, François ; Becker, Hans-Christoph ; Rengo, Marco ; Caudron, Jerome ; Leschka, Sebastian ; Vignaux, Olivier ; Knobloch, Gesine ; Benea, Giorgio ; Schlosser, Thomas ; Andreu, Jordi ; Cabeza, Beatriz ; Jacquier, Alexis ; Souto, Miguel ; Revel, Didier ; Qanadli, Salah Dine ; Cademartiri, Filippo ; X-ACT Study Group ; on behalf of the X-ACT Study Group</creatorcontrib><description>Objectives To demonstrate non-inferiority of iobitridol 350 for coronary CT angiography (CTA) compared to higher iodine content contrast media regarding rate of patients evaluable for the presence of coronary artery stenoses. Methods In this multicentre trial, 452 patients were randomized to receive iobitridol 350, iopromide 370 or iomeprol 400 and underwent coronary CTA using CT systems with 64-detector rows or more. Two core lab readers assessed 18 coronary segments per patient regarding image quality (score 0 = non diagnostic to 4 = excellent quality), vascular attenuation, signal and contrast to noise ratio (SNR, CNR). Patients were considered evaluable if no segment had a score of 0. Results Per-patient, the rate of fully evaluable CT scans was 92.1, 95.4 and 94.6 % for iobitridol, iopromide and iomeprol, respectively. Non-inferiority of iobitridol over the best comparator was demonstrated with a 95 % CI of the difference of [-8.8 to 2.1], with a pre-specified non-inferiority margin of -10 %. Although average attenuation increased with higher iodine concentrations, average SNR and CNR did not differ between groups. Conclusions With current CT technology, iobitridol 350 mg iodine/ml is not inferior to contrast media with higher iodine concentrations in terms of image quality for coronary stenosis assessment. Key Points • Iodine concentration is an important parameter for image quality in coronary CTA. • Contrast enhancement must be balanced against the amount of iodine injected. • Iobitridol 350 is non-inferior compared to CM with higher iodine concentrations. • Higher attenuation with higher iodine concentrations, but no SNR or CNR differences.</description><identifier>ISSN: 0938-7994</identifier><identifier>EISSN: 1432-1084</identifier><identifier>DOI: 10.1007/s00330-016-4437-9</identifier><identifier>PMID: 27271922</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Adult ; Aged ; Calcification ; Calcinosis - diagnostic imaging ; Cardiovascular disease ; Clinical medicine ; Computed Tomography Angiography - methods ; Contrast agents ; Contrast Media ; Coronary Angiography - methods ; Coronary Artery Disease - diagnostic imaging ; Coronary Stenosis - diagnostic imaging ; Coronary vessels ; Diagnostic Radiology ; Double-Blind Method ; Female ; Humans ; Imaging ; Internal Medicine ; Interventional Radiology ; Iodine ; Iohexol - analogs &amp; derivatives ; Iopamidol - analogs &amp; derivatives ; Male ; Medical imaging ; Medicine ; Medicine &amp; Public Health ; Middle Aged ; Multidetector Computed Tomography - methods ; Neuroradiology ; Patients ; Radiology ; Tomography ; Tomography, X-Ray Computed - methods ; Ultrasound</subject><ispartof>European radiology, 2017-02, Vol.27 (2), p.821-830</ispartof><rights>The Author(s) 2016</rights><rights>European Radiology is a copyright of Springer, 2017.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c503t-72950ffd2c8c3fd3fbaa2bae1ecfc7871b912df07223d33fdf4e8c449bbd738c3</citedby><cites>FETCH-LOGICAL-c503t-72950ffd2c8c3fd3fbaa2bae1ecfc7871b912df07223d33fdf4e8c449bbd738c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27271922$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Achenbach, Stephan</creatorcontrib><creatorcontrib>Paul, Jean-François</creatorcontrib><creatorcontrib>Laurent, François</creatorcontrib><creatorcontrib>Becker, Hans-Christoph</creatorcontrib><creatorcontrib>Rengo, Marco</creatorcontrib><creatorcontrib>Caudron, Jerome</creatorcontrib><creatorcontrib>Leschka, Sebastian</creatorcontrib><creatorcontrib>Vignaux, Olivier</creatorcontrib><creatorcontrib>Knobloch, Gesine</creatorcontrib><creatorcontrib>Benea, Giorgio</creatorcontrib><creatorcontrib>Schlosser, Thomas</creatorcontrib><creatorcontrib>Andreu, Jordi</creatorcontrib><creatorcontrib>Cabeza, Beatriz</creatorcontrib><creatorcontrib>Jacquier, Alexis</creatorcontrib><creatorcontrib>Souto, Miguel</creatorcontrib><creatorcontrib>Revel, Didier</creatorcontrib><creatorcontrib>Qanadli, Salah Dine</creatorcontrib><creatorcontrib>Cademartiri, Filippo</creatorcontrib><creatorcontrib>X-ACT Study Group</creatorcontrib><creatorcontrib>on behalf of the X-ACT Study Group</creatorcontrib><title>Comparative assessment of image quality for coronary CT angiography with iobitridol and two contrast agents with higher iodine concentrations: iopromide and iomeprol. A multicentre randomized double-blind trial</title><title>European radiology</title><addtitle>Eur Radiol</addtitle><addtitle>Eur Radiol</addtitle><description>Objectives To demonstrate non-inferiority of iobitridol 350 for coronary CT angiography (CTA) compared to higher iodine content contrast media regarding rate of patients evaluable for the presence of coronary artery stenoses. Methods In this multicentre trial, 452 patients were randomized to receive iobitridol 350, iopromide 370 or iomeprol 400 and underwent coronary CTA using CT systems with 64-detector rows or more. Two core lab readers assessed 18 coronary segments per patient regarding image quality (score 0 = non diagnostic to 4 = excellent quality), vascular attenuation, signal and contrast to noise ratio (SNR, CNR). Patients were considered evaluable if no segment had a score of 0. Results Per-patient, the rate of fully evaluable CT scans was 92.1, 95.4 and 94.6 % for iobitridol, iopromide and iomeprol, respectively. Non-inferiority of iobitridol over the best comparator was demonstrated with a 95 % CI of the difference of [-8.8 to 2.1], with a pre-specified non-inferiority margin of -10 %. Although average attenuation increased with higher iodine concentrations, average SNR and CNR did not differ between groups. Conclusions With current CT technology, iobitridol 350 mg iodine/ml is not inferior to contrast media with higher iodine concentrations in terms of image quality for coronary stenosis assessment. Key Points • Iodine concentration is an important parameter for image quality in coronary CTA. • Contrast enhancement must be balanced against the amount of iodine injected. • Iobitridol 350 is non-inferior compared to CM with higher iodine concentrations. • Higher attenuation with higher iodine concentrations, but no SNR or CNR differences.</description><subject>Adult</subject><subject>Aged</subject><subject>Calcification</subject><subject>Calcinosis - diagnostic imaging</subject><subject>Cardiovascular disease</subject><subject>Clinical medicine</subject><subject>Computed Tomography Angiography - methods</subject><subject>Contrast agents</subject><subject>Contrast Media</subject><subject>Coronary Angiography - methods</subject><subject>Coronary Artery Disease - diagnostic imaging</subject><subject>Coronary Stenosis - diagnostic imaging</subject><subject>Coronary vessels</subject><subject>Diagnostic Radiology</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Imaging</subject><subject>Internal Medicine</subject><subject>Interventional Radiology</subject><subject>Iodine</subject><subject>Iohexol - analogs &amp; derivatives</subject><subject>Iopamidol - analogs &amp; derivatives</subject><subject>Male</subject><subject>Medical imaging</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Middle Aged</subject><subject>Multidetector Computed Tomography - methods</subject><subject>Neuroradiology</subject><subject>Patients</subject><subject>Radiology</subject><subject>Tomography</subject><subject>Tomography, X-Ray Computed - methods</subject><subject>Ultrasound</subject><issn>0938-7994</issn><issn>1432-1084</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><recordid>eNqNks9qFTEUhwdR7G31AdxIwI2bqfl3byYuhHKxKhTc1HXITM7MTckkt0mm5fYxfSIznVqqILgKyfnOd5Lwq6o3BJ8SjMWHhDFjuMZkU3PORC2fVSvCGa0JbvjzaoUla2ohJT-qjlO6whhLwsXL6ogKKoikdFX93IZxr6PO9gaQTglSGsFnFHpkRz0Aup60s_mA-hBRF2LwOh7Q9hJpP9gwRL3fHdCtzTtkQ2tztCa4UjMo34bC-xx1yqiIfE4Lt7PDDmLBjfUwIx3MVLbBp4_leB_DaA3cS2wYoezdKTpD4-SyvWcBxVIs1B0YZMLUOqhbZ-eh0Wr3qnrRa5fg9cN6Uv04_3y5_VpffP_ybXt2UXdrzHItqFzjvje0azrWG9a3WtNWA4Gu70QjSCsJNT0WlDLDCtFzaDrOZdsawUrPSfVp8e6ndgSzPMOpfSwfFw8qaKv-rHi7U0O4UWuKJae8CN4_CGK4niBlNdrUgXPaQ5iSIs1actmwBv8HSjebIsVNQd_9hV6FKfryE7Ow-NZUzBRZqC6GlCL0j_cmWM3hUku4VAmXmsOlZOl5-_TBjx2_01QAugCplPwA8cnof1p_ARho4gA</recordid><startdate>20170201</startdate><enddate>20170201</enddate><creator>Achenbach, Stephan</creator><creator>Paul, Jean-François</creator><creator>Laurent, François</creator><creator>Becker, Hans-Christoph</creator><creator>Rengo, Marco</creator><creator>Caudron, Jerome</creator><creator>Leschka, Sebastian</creator><creator>Vignaux, Olivier</creator><creator>Knobloch, Gesine</creator><creator>Benea, Giorgio</creator><creator>Schlosser, Thomas</creator><creator>Andreu, Jordi</creator><creator>Cabeza, Beatriz</creator><creator>Jacquier, Alexis</creator><creator>Souto, Miguel</creator><creator>Revel, Didier</creator><creator>Qanadli, Salah Dine</creator><creator>Cademartiri, Filippo</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QO</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7P</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20170201</creationdate><title>Comparative assessment of image quality for coronary CT angiography with iobitridol and two contrast agents with higher iodine concentrations: iopromide and iomeprol. 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A multicentre randomized double-blind trial</atitle><jtitle>European radiology</jtitle><stitle>Eur Radiol</stitle><addtitle>Eur Radiol</addtitle><date>2017-02-01</date><risdate>2017</risdate><volume>27</volume><issue>2</issue><spage>821</spage><epage>830</epage><pages>821-830</pages><issn>0938-7994</issn><eissn>1432-1084</eissn><abstract>Objectives To demonstrate non-inferiority of iobitridol 350 for coronary CT angiography (CTA) compared to higher iodine content contrast media regarding rate of patients evaluable for the presence of coronary artery stenoses. Methods In this multicentre trial, 452 patients were randomized to receive iobitridol 350, iopromide 370 or iomeprol 400 and underwent coronary CTA using CT systems with 64-detector rows or more. Two core lab readers assessed 18 coronary segments per patient regarding image quality (score 0 = non diagnostic to 4 = excellent quality), vascular attenuation, signal and contrast to noise ratio (SNR, CNR). Patients were considered evaluable if no segment had a score of 0. Results Per-patient, the rate of fully evaluable CT scans was 92.1, 95.4 and 94.6 % for iobitridol, iopromide and iomeprol, respectively. Non-inferiority of iobitridol over the best comparator was demonstrated with a 95 % CI of the difference of [-8.8 to 2.1], with a pre-specified non-inferiority margin of -10 %. Although average attenuation increased with higher iodine concentrations, average SNR and CNR did not differ between groups. Conclusions With current CT technology, iobitridol 350 mg iodine/ml is not inferior to contrast media with higher iodine concentrations in terms of image quality for coronary stenosis assessment. Key Points • Iodine concentration is an important parameter for image quality in coronary CTA. • Contrast enhancement must be balanced against the amount of iodine injected. • Iobitridol 350 is non-inferior compared to CM with higher iodine concentrations. • Higher attenuation with higher iodine concentrations, but no SNR or CNR differences.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>27271922</pmid><doi>10.1007/s00330-016-4437-9</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record>
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identifier ISSN: 0938-7994
ispartof European radiology, 2017-02, Vol.27 (2), p.821-830
issn 0938-7994
1432-1084
language eng
recordid cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5209424
source Springer Nature
subjects Adult
Aged
Calcification
Calcinosis - diagnostic imaging
Cardiovascular disease
Clinical medicine
Computed Tomography Angiography - methods
Contrast agents
Contrast Media
Coronary Angiography - methods
Coronary Artery Disease - diagnostic imaging
Coronary Stenosis - diagnostic imaging
Coronary vessels
Diagnostic Radiology
Double-Blind Method
Female
Humans
Imaging
Internal Medicine
Interventional Radiology
Iodine
Iohexol - analogs & derivatives
Iopamidol - analogs & derivatives
Male
Medical imaging
Medicine
Medicine & Public Health
Middle Aged
Multidetector Computed Tomography - methods
Neuroradiology
Patients
Radiology
Tomography
Tomography, X-Ray Computed - methods
Ultrasound
title Comparative assessment of image quality for coronary CT angiography with iobitridol and two contrast agents with higher iodine concentrations: iopromide and iomeprol. A multicentre randomized double-blind trial
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