Clinical Trial of Manganese-Enhanced MRI (MEMRI) to Assess Peri-Infarct Injury

This is an open-label, baseline-controlled study to be conducted. Adult male or nonpregnant
female patients who have been referred for evaluation of dilated cardiomyopathy, ischemic
cardiomyopathy, non-ischemic cardiomyopathy, atrial arrthymia and also patients who have
received stem cell therapy related to both ischemic and dilated cardiomyopathy (under
different trials) will be recruited. An initial cohort study of 6 patients to conduct safety
evaluation was conducted before proceeding with 60 additional patients. In the initial
cohort, a patient was dosed based on the Phase 1 and 2 clinical trial data evaluation
completed by Eagle Vision Pharmaceutical, Inc. Subjects were excluded if they had received
an investigational device within 30 days prior to administration of EVP1001-1; had a history
of drug abuse or alcoholism; were taking a digitalis preparation; had a history of torsades;
had NYHA Grade IV heart failure; had abnormal liver function tests or a history of liver
disease; had uncontrolled hypertension; had abnormal calcium, potassium or hemoglobin values
at baseline; if they develop a cardiac arrhythmia prior to or during either of the exercise
tests-- EVP1001-1 was not administered. The same parameters will apply to the new group of
subjects.

Prior to entry into this study, all subjects will sign an Informed Consent and will undergo
a physical examination including medical history, details regarding their cardiac history,
prescription and over-the-counter drug questionnaire, vital signs, electrocardiogram (ECG),
evaluation of the major organ systems, hematology, serum chemistries, and urinalysis. In
addition, female subjects will undergo a serum pregnancy test.

Starting 30 minutes before the cardiac MRI scan (CMR), the subjects will take a 16 mg tablet
of ondansetron by mouth. CMR imaging will subsequently take place and then EVP1001-1 will
then be administered approximately 15 minutes into the scan for contrast enhanced images.
EVP1001-1 will be administered intravenously over approximately one minute. The subjects
will each receive 0.28 mL/kg of EVP 1001-1. All subjects will be monitored closely from
before ondansetron administration until their discharge from the imaging center. Following
MEMRI, delayed-enhanced MRI (DEMRI) is performed using 0.2mmol/kg.

We will compare the two different contrast enhanced images (EVP1001-1 vs Gadolinium) in
determining the viable, peri-infarct, and intra-infarct myocardial tissue

Inclusion Criteria:

All subjects to be entered must:

- be at least 18 years of age.

- if female, be nonpregnant as evidenced by a serum pregnancy test and using a
medically-approved method of birth control, or post-menopausal or surgically sterile

- provide written informed consent after having received oral and written information
about the study

- be in stable health based on medical history, examination and tests

Exclusion Criteria:

have a positive pregnancy test (females)

- received an investigational drug or device within 30 days prior to administration of
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- have known hypersensitivity to ondansetron or other selective serotonin 5HT3 receptor
blockers

- have a history of drug abuse or alcoholism

- are taking a digitalis preparation or calcium channel blocker

- have a history of torsades or prolonged QT/QTc interval

- have NYHA Grade IV heart failure

- have abnormal liver function tests or a history of liver disease

- have uncontrolled hypertension (Systolic Blood Pressure > 140 or Diastolic BP > 90
consistently at baseline)

- have abnormal baseline potassium or calcium values or hemoglobin less than 10 g/dl

- are noncompliant or otherwise unlikely to perform as required by the protocol

- have pretest likelihood of CAD for which the requisite number of subjects have been
entered

- develop an arrhythmia prior to or during either of the exercise tests; SeeMore should
not be administered.