Efficacy of EVP 1001-1 (SeeMore) in the Assessment of Myocardial Viability in Patients With Cardiovascular Disease

This is an open-label, baseline-controlled study. An initial cohort study of patients to conduct safety evaluation will be conducted before proceeding with the additional patients. In this initial cohort, a patient will be dosed based on the Phase 1 and 2 clinical trial data evaluation completed by Eagle Vision Pharmaceutical, Inc.

Starting 30 minutes before the cardiac MRI scan (CMR), the subjects will take a 4 mg tablet of ondansetron by mouth. CMR will subsequently take place and SeeMore™ will then be administered approximately 15 minutes into the scan for contrast enhanced images. SeeMore™ will be administered intravenously over approximately one minute. The subjects will each receive 0.28 mL/kg of SeeMore™. All subjects will be monitored closely from before ondansetron administration until their discharge from the imaging center. If positive delayed-enhanced MRI is detected, the subject will undergo MEMRI within 1 week. The investigators plan to perform imaging with CMR and SeeMore™ within a week after standard gadolinium-based delayed enhanced imaging by CMR (performed as clinically indicated within Stanford Hospital by the patient's physician) to directly compare the two different contrast enhanced images (SeeMore vs Gadolinium in determining viable myocardium).

Parameters to be Measured:

A standard physical examination will be performed within 24 hours prior to dosing and at the end of experimental MEMRI imaging (approximately 1 hour post dosing). A standard 12-lead EKG will be performed both before the experimental MR study and after the experimental MR study to assure no significant EKG changes have occurred. HR will be measured before and after the study. After the study, the patient will have another standard 12-lead EKG performed to compare with the pre-MRI 12-lead EKG. The patient's symptoms will be reassessed 1 hour and 1 year after infusion of the SeeMore contrast. Adverse events (AEs) and discomforts will be recorded until discharge from the imaging center. Any clinically relevant changes from baseline in vital signs, ECG rhythm, clinical chemistries or physical condition and all AEs will be followed until resolution or until the outcome is known. Primary efficacy will be based on determining whether the heart is normal or abnormal and if abnormal whether there is an infarction, ischemia or both. This provides the basis for calculating sensitivity, specificity, accuracy and predictive values. In addition, the location, size, conspicuity and associated confidence for any disease will be recorded.

The study will be stopped for any significant adverse cardiovascular event including cardiovascular death, myocardial infarction, ventricular arrhythmia, ICD firing, congestive heart failure, hospitalization, or syncope.