Safety and Efficacy of SeeMore (TM) in Heart Patients
This study will examine the safety and effectiveness of a manganese-based agent called SeeMore (EVP 1001-1 Injection) for enhancing magnetic resonance imaging (MRI) in patients who have previously had a heart attack. It will determine whether SeeMore makes it easier to find damaged areas of the heart and will evaluate how well patients feel and how their bodies react after receiving the study medication.
Adult patients who have previously had a heart attack and are in stable health may be eligible for this study. Candidates are screened with a medical history, a brief physical examination and blood and urine tests.
Participants undergo the following procedures:
- Collection of blood and urine samples 24 hours before receiving SeeMore and 24 hours after. A blood sample is also taken 3 and 10 days after receiving the drug.
- MRI scans one hour before receiving SeeMore and 10 minutes after receiving the drug. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. After the first (baseline) MRI is done, SeeMore is given intravenously (through a vein) and the subject's vital signs and electrocardiogram (EKG) are monitored for 10 minutes. Then the second MRI is done to determine whether the study medication makes it easier to see areas of the heart that were affected by the heart attack.
- Check of vital signs, EKG and physical examination after the second MRI.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||An Open-label, Baseline-Controlled Study of the Safety and Efficacy of SeeMore (TM) (EVP 1001-1 Injection) in Heart Patients|
- Examine the safety and tolerance of SeeMore following intravenous injection in patients known to have had a myocardial infarct [ Time Frame: within 24 hours ] [ Designated as safety issue: Yes ]
- To assess the efficacy (enhancement features) of SeeMore for identifying myocardial infarction [ Time Frame: within 1 hour ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||March 2012|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
This is a Phase II open-label, baseline-controlled study. Approximately 10 adult male or nonpregnant female patients known to have had a myocardial infarct (nonacute) are intended to be enrolled at the current dose.
Prior to entry into this study, all subjects will undergo a standard physical examination including medical history, details regarding the prior myocardial infarct(s), prescription and over-the-counter drug questionnaire, vital signs, ECG, evaluation of the major organ systems, hematology, serum chemistries, and urinalysis. In addition, female subjects will undergo a serum pregnancy test. All subjects will sign an Informed Consent prior to entry into the study.
EVP 1001-1 will be administered intravenously over approximately one minute. Safety will be assessed by monitoring vital signs, ECG, and blood test after giving EVP 1001-1. MRI will be performed before and after EVP-1001-1 to measure enhancement relative to areas of myocardial infarction.