Clinical Trial of Manganese-Enhanced MRI (MEMRI) to Assess Peri-Infarct Injury
Condition: ISCHEMIC CARDIOMYOPATHY
MeSH terms: Cardiomyopathies; Infarction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and tolerance of a new intravenous
      diagnostic agent, SeeMore or EVP 1001-1, in patients with Cardiovascular Disease (MEMRI
      scan). The initial phase of this study, NCT01989195 enrolling a total of 6 patients, has been
      closed. This second phase adds 10 patients in a safety cohort and 60 additional patients for
      a total of 70 patients.
    

Detailed description: 
      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 arrhythmia 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
      New York Heart Association (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 scan) is performed using 0.2 mmol/kg.

      We will compare the two different contrast enhanced images (EVP1001-1 vs gadolinium (GD)) in
      determining the non-viable (infarct core), peri-infarct, and total infarct size of myocardial
      tissue.
    

Intervention name(s): Manganese-enhanced MRI contrast reagent; Gadolinium-enhanced MRI contrast reagent
Intervention type(s): Drug; Drug
Intervention description(s): MRI using manganese-enhanced MRI contrast reagent (manganese 0.28 mL/kg).; MRI using gadolinium-enhanced MRI contrast reagent (gadolinium 0.2 mmol/kg).
Other intervention name(s): EVP 1001-1; GD-DTPA
Intervention MeSH terms: Manganese
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ISCHEMIC OR CORONARY HEART DISEASE; MYOCARDIAL INFARCTION; MAGNETIC RESONANCE IMAGING; DELAYED GADOLINIUM ENHANCEMENT MRI; MANGANESE-ENHANCED MRI; INFARCT VOLUME/SIZE; ALL CAUSE MORTALITY; VENTRICULAR ARRHYTHMIAS