Biomarkers Consortium - Carotid MRI Development and Validation via an AIMHIGH Sub-Study

The Carotid MRI Reproducibility Study is a sub-study of a NHLBI-managed trial, called AIM HIGH. The goal of this project was to conduct a 75-patient study at a total of 15 centers to determine the reproducibility of the non-invasive technique of carotid magnetic resonance imaging (CMRI). In this study, randomly selected subjects from each of the 15 imaging centers were scanned twice (once at baseline and then again two weeks later) using identical imaging protocols and sequences. The two resulting sets of images were first reviewed independently by one reviewer to assess intra-scan variability, and then reviewed by two raters to assess inter-rater and intra-rater variability. Through the reproducibility study the Principal Investigators were able to document the variability of a number of parameters for each site, scanner, etc. Both GE and Philips scanners were used at the sites. Results established a standardized carotid MRI protocol and determined, for the first time, that kinetic parameters of carotid atherosclerotic plaque are reproducible and can be used for multi-center studies.

Goals

  • Establish a standardized carotid MRI protocol at 15 centers with 3T whole body MRI scanners (GE, Philips, and/or Siemens) that provides plaque burden, tissue composition and plaque neo-vasculature and inflammation information.
  • Conduct a reproducibility study (5 subjects at each of the 15 participating sites with every subject having two identical MRI scans within 2 weeks).

Results & Accomplishments

Results established a standardized carotid MRI protocol and determined, for the first time, that kinetic parameters of carotid atherosclerotic plaque are reproducible and can be used for multi-center studies.

Scientific Publications

Scan-rescan reproducibility of quantitative assessment of inflammatory carotid atherosclerotic plaque using dynamic contrast-enhanced 3T CMR in a multi-center study Huijun Chen, Jie Sun, William S Kerwin, Niranjan Balu, Moni B Neradilek, Daniel S Hippe, Daniel Isquith, Yunjing Xue, Kiyofumi Yamada, Suzanne Peck Chun Yuan Kevin D O’Brien and Xue-Qiao Zhao J Cardiovasc Magn Reson. 2014; 16(1): 51.

Carotid magnetic resonance imaging for monitoring atherosclerotic plaque progression: a multicenter reproducibility study Jie Sun, Xue-Qiao Zhao, Niranjan Balu, Daniel S. Hippe, Thomas S. Hatsukami, Daniel A. Isquith, Kiyofumi Yamada, Moni B. Neradilek, Gádor Cantón, Yunjing Xue, Jerome L. Fleg, Patrice Desvigne-Nickens, Michael T. Klimas, Robert J. Padley, Maria T. Vassileva, Bradley T. Wyman, and Chun YuanInt J Cardiovasc Imaging. 2015 Jan; 31(1): 95–103.

Partners

Abbott
Merck
National Heart, Lung, and Blood Institute (NHLBI)
Pfizer
University of Washington
U.S. Food and Drug Administration (FDA)

Contact

Joseph P. Menetski, Ph.D., Deputy Director of Research Partnerships, jmenetski@fnih.org