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.
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