CMR Viability in a Heart Failure Trial

Challenge

A heart failure outcomes trial required centralized assessment of myocardial viability by cardiac MRI to determine subject eligibility, since the investigational therapy's mechanism depended on the presence of viable myocardium. Late gadolinium enhancement imaging is technically demanding, and site-performed interpretations varied enough to risk enrolling subjects who could not benefit—or excluding those who could. Eligibility determinations also had to be returned quickly, because randomization windows were narrow.

Our Solution

Intrinsic Imaging standardized late gadolinium enhancement acquisition across all 60 sites through protocol-specific training and prospective quality control, ensuring that inversion times and imaging planes met the charter's requirements before studies reached readers. Fellowship-trained cardiac MRI specialists performed centralized viability assessment using a structured segmental scoring system, with dual independent reads and adjudication for discordant cases. Eligibility results were returned to sites within 48 hours through automated notification.

Results

• Eligibility reads returned within 48 hours
• Inter-reader agreement of 0.94 on viability scoring
• Enrollment completed ahead of projections