FAST-CMR: Multi-center, multi-vendor trial to validate free-running cardiac MRI framework

A prospective, 21-site, two-vendor study (FAST-CMR) will evaluate a free-running, non-ECG-gated cardiac MRI framework (5D FISS-FRF) in 300 patients with cardiac disease, comparing LVEF precision to conventional cine.

• Prospective, observational, intra-individually controlled design enrolling 300 patients across three cohorts: congenital heart disease, unable to breath-hold, and able to breath-hold.
• Participants will undergo conventional 2D cine bSSFP and a 6-minute post-contrast 5D FISS-FRF acquisition; primary endpoint is precision of mean paired difference in left ventricular ejection fraction.
• Centralized reconstruction and blinded core laboratory analysis will be used to assess generalizability and robustness across 21 international sites and two vendor systems.

Automated summary

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