A Post-marketing Clinical Study to Confirm the Efficacy of 18 F-fluorodeoxyglucose for the Diagnosis of Myocardial Viability: A Prospective Multicenter Study in Patients with Ischemic Heart Disease

Background: A number of previous studies have shown that myocardial viability can be assessed by positron emission tomography (PET) using 18 F-fluorodeoxyglucose ( 18 F-FDG). However, there has been no multicenter study that verified the ability of this modality for diagnosing myocardial viability in Japan. We therefore conducted a prospective one arm's unrandomized multicenter clinical trial in order to confirm the diagnostic ability of 18 F-FDG (95% two-sided confidence interval) in the 30 patients of the efficacy-analysis set was 63.9 %( 54.6-72.5%). Moreover, the proportion of patients with improved wall motion, on a per-patient basis, was 86.7 %( 26 of 30 cases). As for the safety, no serious adverse events occurred and the agent was well-tolerated. Conclusions: The identification of myocardial viability by 18 F-FDG will be widely beneficial in predicting improvement in myocardial wall motion after coronary revascularization. No serious safety concerns associated with the use of 18 F-FDG were observed.