RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)

Study Summary

This a Phase 3, prospective, open-label, multicenter study of \[15-O\]-H2O injection for PET imaging of subjects with suspected CAD. Approximately 182 evaluable participants with suspected CAD referred for testing will be included in the study at approximately 10 study sites in the United States and Europe. Approximately 215 participants will be enrolled to account for an estimated 15% drop-out rate. Screening assessments will occur prior to enrollment to confirm eligibility. All participants will receive two doses of \[15-O\]-H2O as part of a single PET imaging session (one dose at rest and one during pharmacological stress with adenosine). A safety follow-up phone call will occur 24 ± 8 hrs after completion of the \[15-O\]-H2O scan.

Primary Outcome

Sensitivity and specificity are defined as follows: * True Positives (TP): Subjects with abnormal PET MPI and disease positive by the truth standard * True Negatives (TN): Subjects with normal PET MPI and disease negative by the truth standard * False Positives (FP): Subjects with abnormal PET MPI and disease negative by the truth standard * False Negatives (FN): Subjects with normal PET MPI and disease positive by the truth standard * Sensitivity: TP/(TP + FN) * Specificity: TN/(TN + FP)

Conditions Studied

Interventions

• DRUG [O-15]-Water PET Myocardial Perfusion Imaging (MPI)

Study Locations (14)