Safety and Efficacy of SeeMore (TM) in Heart Patients



Status:Archived
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:June 2008

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An Open-label, Baseline-Controlled Study of the Safety and Efficacy of SeeMore (TM) (EVP 1001-1 Injection) 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.


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.


We found this trial at
1
site
601 Elmwood Ave
Rochester, New York 14642
(585) 275-2100
Strong Memorial Hospital (University of Rochester School of Medicine) In addition to offering traditional and...
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mi
from
Rochester, NY
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