Safety and Efficacy of SeeMore (TM) in Heart Patients
Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
Summary
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.