Global Cardiovascular Trial With CCTA and MRI

Challenge

This global cardiovascular outcomes trial required reproducible quantification of coronary plaque burden, stenosis grading, and left ventricular ejection fraction across 60 sites operating a heterogeneous mix of scanner models. Each measurement carried endpoint-level significance, and even modest inter-reader or inter-site variability risked obscuring treatment effects. The sponsor needed assurance that a scan acquired at any site, on any supported scanner, would yield measurements directly comparable to those from every other site in the program.

Our Solution

Intrinsic Imaging established standardized acquisition guidelines tailored to each scanner platform and enforced them through a dedicated quality control gateway that intercepted unusable or non-conformant scans before they reached central review, with prompt feedback enabling sites to correct deficiencies. Central readers underwent structured training and continuous calibration throughout the trial, so that plaque quantification, stenosis grading, and ejection fraction measurement remained uniform from the first patient enrolled to the last.

Results

• 99.1% evaluable scan rate across 3400+ patients
• Inter-reader variability maintained below 4%
• Ongoing reader calibration throughout the trial