Silica-gold nanoparticles for atheroprotective management of plaques: Results of the NANOM-FIM trial / Kharlamov A.N., Tyurnina A.E., Veselova V.S., Kovtun O.P., Shur V.Y., Gabinsky J.L. // Nanoscale. - 2015. - V. 7, l. 17. - P. 8003-8015.

ISSN:
20403364
Type:
Article
Abstract:
Background: Atheroregression becomes an attractive target for cardiovascular treatment. Some clinical trials have demonstrated that intensive therapy with rosuvastatin or recombinant ApoA-I Milano can partially reduce the total atheroma volume (TAV) up to 6.38 mm3 or 14.1 mm3 respectively. Our previous bench studies of selected nanotechnologies documented TAV reduction up to an unprecedented 79.4 mm3. Methods: The completed observational three arms (n = 180) first-in-man trial (the NANOM FIM trial) assessed (NCT01270139) the safety and feasibility of two delivery techniques for nanoparticles (NP), and plasmonic photothermal therapy (PPTT). Patients were assigned to receive either (1) nano-intervention with delivery of silica-gold NP in a bioengineered on-artery patch (n = 60), or (2) nano-intervention with delivery of silica-gold iron-bearing NP with targeted micro-bubbles and stem cells using a magnetic navigation system (n = 60) versus (3) stent implantation (n = 60). The primary outcome was TAV at 12 months. Results: The mean TAV reduction at 12 months in the Nano group was 60.3 mm3 (SD 39.5; min 41.9 mm3, max 94.2 mm3; p < 0.05) up to mean 37.8% (95% CI: 31.1%, 51.7%; p < 0.05) plaque burden. The analysis of the event free survival of the ongoing clinical follow-up shows the significantly lower risk of cardiovascular death in the Nano group when compared with others (91.7% vs. 81.7% and 80% respectively; p < 0.05) with no cases of the target lesion-related complications. Conclusions: PPTT using silica-gold NP associated with significant regression of coronary atherosclerosis. © The Royal Society of Chemistry 2015.
Author keywords:
Index keywords:
Gold; Nanoparticles; Navigation systems; Risk assessment; Silica; Stem cells; Clinical trial; Delivery techniques; Gold Nanoparticles; Intensive therapy; Magnetic navigation systems; Micro-bubble; Pho
DOI:
10.1039/c5nr01050k
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https://www.scopus.com/inward/record.uri?eid=2-s2.0-84929494405&doi=10.1039%2fc5nr01050k&partnerID=40&md5=3bad7805d626335b4cd9a21c98fb0b0b
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Link https://www.scopus.com/inward/record.uri?eid=2-s2.0-84929494405&doi=10.1039%2fc5nr01050k&partnerID=40&md5=3bad7805d626335b4cd9a21c98fb0b0b
Affiliations De Haar Research Foundation, Rotterdam, Netherlands; Department of Science, Department of Interventional Cardiology, Ural Institute of Cardiology, Yekaterinburg, Russian Federation; Division of Science, Ural Medical University, Yekaterinburg, Russian Federation; Ural Center of Modern Nanotechnologies, Institute of Natural Sciences, Ural Federal University, Yekaterinburg, Russian Federation
Chemicals/CAS gold, 7440-57-5; silicon dioxide, 10279-57-9, 14464-46-1, 14808-60-7, 15468-32-3, 60676-86-0, 7631-86-9; Gold; Silicon Dioxide
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Correspondence Address Kharlamov, A.N.; De Haar Research FoundationNetherlands
Publisher Royal Society of Chemistry
PubMed ID 25864858
Language of Original Document English
Abbreviated Source Title Nanoscale
Source Scopus