Etudes de validation
FMD Studio has been validated in 50 healthy subjects (mean age 25 ± 5 years) and 220 patients with more than one cardiovascular risk factor (mean age 59 ± 14 years). Flow-mediated dilatation was lower in patients than in healthy subjects (5.3 ± 2.9% vs 7.1 ± 2.5%, p = 0.001), while mean brachial diameter at rest was significantly larger in patients (4.32 ± 0.09 mm vs 4.19 ± 0.08 mm, p = 0.01). The system has also been validated in a multicenter study involving seven centers and 675 FMD/GTN scans. Overall intra-day variability (1 hour apart) was CV = 9.9%, overall inter-day variability (1 month apart) was CV = 12.9%. The results showed that FMD Studio provides reproducible FMD assessment and can be adopted in multicenter clinical trials.
FMD Studio is now used in clinics worldwide.
Carotid Studio has been validated in 87 healthy subjects (mean age 48 ± 14 years) and 311 patients with more than one cardiovascular risk factor (mean age 58 ± 11 years). Intima Media Thickness was greater in patients than in healthy subjects (0.75 ± 0.26 mm vs 0.68±0.15 mm, p = 0.001),
Carotid studio has been compared with echo-tracking technology to evaluate the accuracy of intima media thickness (IMT), diameter (D) and stroke changes in diameter (ΔD) measures. Bland Altman analysis showed a bias ± standard deviation of 0.006 ± 0.039mm for IMT, 0.060 ± 0.110mm for D and 0.016 ± 0.039mm for ΔD. In addition, reproducibility was evaluated and intra-observer CVs were 6 ± 6% for IMT, 2 ± 1% for D and 8 ± 6% for IMT. Results showed that Carotid Studio overcomes the limitations of standard image analysis and that it is a suitable device for measuring IMT and local arterial stiffness parameters in clinical studies.
studio is one of the automatic measurement systems considered by the European Network for Non-Invasive Investigation of Large Arteries.
Gemignani V, Bianchini E, Faita F, Giannarelli C, Plantinga Y, Ghiadoni L, Demi M.
“Ultrasound measurement of the brachial artery flow-mediated dilation without ECG gating.”
Ultrasound Med Biol. 2008 Mar;34(3):385-91. Epub 2007 Oct 26.
Faita F, Gemignani V, Bianchini E, Giannarelli C, Ghiadoni L, Demi M.
“Real-time measurement system for evaluation of the carotid intima-media thickness with a robust edge operator.”
J Ultrasound Med. 2008 Sep;27(9):1353-61
Bianchini E, Bozec E, Gemignani V, Faita F, Giannarelli C, Ghiadoni L, Demi M, Boutouyrie P, Laurent S.
“Assessment of carotid stiffness and intima-media thickness from ultrasound data: comparison between two methods.”
J Ultrasound Med. 2010 Aug;29(8):1169-75.
Faita F, Masi S, Loukogeorgakis S, Gemignani V, Okorie M, Bianchini E, Charakida M, Demi M, Ghiadoni L, Deanfield JE.
“Comparison of two automatic methods for the assessment of brachial artery flow-mediated dilation.”
J Hypertens. 2011 Jan;29(1):85-90.
Ghiadoni L, Faita F, Salvetti M, Cordiano C, Biggi A, Puato M, Di Monaco A, De Siati L, Volpe M, Ambrosio G, Gemignani V, Muiesan M, Taddei S, Lanza GA, Cosentino F.
“Assessment of Flow-Mediated Dilation Reproducibility: a Nationwide Multicenter Study".
J Hypertens. 2012
Charakida M, Masi S, Lüscher TF, Kastelein JJ, Deanfield JE.
“Assessment of atherosclerosis: the role of flow-mediated dilatation.”
Eur Heart J. 2010 Dec;31(23):2854-61. Epub 2010 Sep 23.
Yeboah J, Crouse JR, Hsu FC, Burke GL, Herrington DM.
“Brachial flow-mediated dilation predicts incident cardiovascular events in older adults: the Cardiovascular Health Study.”
Circulation. 2007 May 8;115(18):2390-7. Epub 2007 Apr 23.
O'Leary DH, Bots ML.
“Imaging of atherosclerosis: carotid intima-media thickness.”
Eur Heart J. 2010 Jul;31(14):1682-9. Epub 2010 Jun 11.
Mattace-Raso FU, van der Cammen TJ, Hofman A, van Popele NM, Bos ML, Schalekamp MA, Asmar R, Reneman RS, Hoeks AP, Breteler MM, Witteman JC.
“Arterial stiffness and risk of coronary heart disease and stroke: the Rotterdam Study.”
Circulation. 2006 Feb 7;113(5):657-63.