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New assay could help predict onset of MI
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Use of a new fluid biopsy technique may help identify patients at high risk for MI, researchers reported.
The high-definition circulating endothelial cell (HD-CEC, Epic Sciences) assay identifies and characterizes circulating endothelial cells. Elevated circulating endothelial cell counts have been reported in multiple diseases, including CVDs, cancer and systemic vasculitis, according to study background information. Previous research has shown that increased numbers of circulating endothelial cells are strongly associated with an ongoing MI and could be a diagnostic tool to predict MI, Kelly Bethel, MD, of Scripps Clinic, La Jolla, Calif., and colleagues wrote.
The researchers collected blood samples from 79 patients with MI, 25 healthy controls and six patients undergoing vascular surgery.
The samples were run through the HD-CEC assay to identify circulating endothelial cells. The assay identifies and characterizes circulating endothelial cells using a combination of morphologic criteria and antibodies against vWF, CD146 and CD45, according to the researchers.
Circulating endothelial cell counts were significantly elevated in patients with MI compared with healthy controls. The mean number of circulating endothelial cells per milliliter was 40.6 for patients with MI vs. 0.3 for healthy controls; the median number of circulating endothelial cells per milliliter was 13.7 for patients with MI vs. 0 for healthy controls. Patients who underwent vascular surgery had lower circulating endothelial cell counts compared with patients with MI, but not significantly different from healthy controls (P=3.19x10-14). Circulating endothelial cell counts did not change in healthy controls with time.
The researchers detected circulating endothelial cells in 65 of 79 patients with MI, 81.5% of which had circulating endothelial cell aggregates. In the 34 blood samples taken from healthy controls, only 14.7% had more than one circulating endothelial cell and none had any sign of aggregates.
The researchers also compared the performance of the HD-CEC assay to a CellSearch assay (Janssen Diagnostics). The areas under the curve for the two technologies were similar (HD-CEC, 93.3%; CellSearch, 95.4%; P>.05), indicating similar sensitivity in the discrimination of patients with MI from healthy controls, according to the researchers. The HD-CEC assay showed superior specificity to the CellSearch assay; at 0.3 circulating endothelial cells per milliliter, the mean count in healthy controls, the HD-CEC assay had 70% specificity vs. <2% specificity for the CellSearch assay, the researchers wrote.
“Our results were so significant relative to the healthy controls that the obvious next step is to assess the usefulness of the test in identifying patients during the early stages of a heart attack,” researcher Peter Kuhn, PhD, of Scripps Research Institute, stated in a press release.
Disclosure: Some researchers have an ownership interest in Epic Sciences, which owns the license for the HD-CEC assay.
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