Cardiovascular Clinical Trial With 1,500 Multimodality Reviews

Challenge

A cardiovascular clinical trial required 1,500 central reviews to evaluate the clinical safety and effectiveness of a new product. Cardiovascular endpoints span modalities, and the trial collected echocardiography, cardiac MRI and CT at different timepoints, each with its own acquisition variability and measurement conventions for cardiac function and structure.

The sponsor needed a single core lab able to manage all three modalities with consistent conventions, so that ejection fraction and chamber dimensions measured on echocardiography could be interpreted alongside cardiac MRI and CT findings, and a review process whose documentation would support both the safety and effectiveness analyses.

Intrinsic Imaging’s Solution

Intrinsic Imaging developed the imaging charter with acquisition standards for each modality, including echocardiographic view and Doppler requirements, cine cardiac MRI parameters and gated CT protocols, and qualified sites on test submissions for each modality in use.

Cardiovascular-trained radiologists and cardiologists reviewed examinations under modality-specific reading charters with harmonized measurement conventions, so that functional measurements were comparable across modalities within the limits of each technique. Primary effectiveness measurements were double-read with adjudication, and safety findings were captured under predefined definitions.

Image transfer, quality control and processing were managed from the San Antonio office, with modality-specific quality checks at receipt and consolidated reporting of safety findings to the sponsor.

Intrinsic Imaging’s Results

• 1,500 multimodality cardiovascular reviews completed across echocardiography, cardiac MRI and CT under harmonized measurement conventions
• Modality-specific acquisition standards adopted at 22 sites with unevaluable examinations under 5%
• Primary effectiveness measurements double-read with reader agreement above 90% and adjudication documented
• Consolidated imaging safety reporting delivered to the sponsor on a defined schedule throughout follow-up