Safety and Efficacy of SeeMore (TM) in Heart Patients - Full Text View

Sponsored by:	Eagle Vision Pharmaceutical Corp.
Information provided by:	Eagle Vision Pharmaceutical Corp.
ClinicalTrials.gov Identifier:	NCT00881075

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction	Drug: SeeMore(TM)	Phase II

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Baseline-Controlled Study of the Safety and Efficacy of SeeMore (TM) (EVP 1001-1 Injection) in Heart Patients

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack MRI Scans

U.S. FDA Resources

Further study details as provided by Eagle Vision Pharmaceutical Corp.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

To assess the efficacy (enhancement features) of SeeMore for identifying myocardial infarction [ Time Frame: within 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	June 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

single dose intravenous injectable

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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
have potassium, calcium and hematocrit values within normal limits
have a prior known myocardial infarction

Exclusion Criteria:

have a positive pregnancy test (females)
received an investigational drug or device within 30 days prior to administration of SeeMore™
have known hypersensitivity to ondansetron or other selective serotonin 5HT3 receptor blockers
have a history of drug abuse or alcoholism
have had a myocardial infarct, unstable angina, stroke of transient ischemic attack (TIA) within the past six months
are taking a digitalis preparation or calcium channel blocker
have arrhythmias requiring medication
have a prolonged PR interval, history of an atrioventricular conduction disorder or sick sinus syndrome
have a prolonged QTc interval, ventricular arrhythmia or history of torsades
have NYHA Grade III or IV heart failure
have abnormal liver function tests or a history of liver disease
have uncontrolled hypertension
have potassium, calcium or hematocrit values outside normal limits
have altered a prescription medication within 14 days or an over-the-counter medication within 7 days
are noncompliant or otherwise unlikely to perform as required by the protocol
if a new cardiac arrhythmia develops prior to the scheduled time for SeeMore™ administration, SeeMore™ will be withheld.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881075

Locations

United States, Maryland
National Institutes of Health Clinical Center	Active, not recruiting
Bethesda, Maryland, United States, 20892
United States, New York
University of Rochester	Recruiting
Rochester, New York, United States, 14642
Contact: Lori Caufield, RN BSN CCRC 585-273-4956 lori_caufield@urmc.rochester.edu
Principal Investigator: Michael Fong, MD
Principal Investigator: David Lee, MD
United States, Ohio
The Cleveland Clinic Foundation	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Kim Austin austink@ccf.org
Principal Investigator: Scott Flamm, MD

Sponsors and Collaborators

Eagle Vision Pharmaceutical Corp.

More Information

Publications:

Mendonca-Dias MH, Gaggelli E, Lauterbur PC. Paramagnetic contrast agents in nuclear magnetic resonance medical imaging. Semin Nucl Med. 1983 Oct;13(4):364-76. Review.

Storey P, Danias PG, Post M, Li W, Seoane PR, Harnish PP, Edelman RR, Prasad PV. Preliminary evaluation of EVP 1001-1: a new cardiac-specific magnetic resonance contrast agent with kinetics suitable for steady-state imaging of the ischemic heart. Invest Radiol. 2003 Oct;38(10):642-52.

Storey P, Chen Q, Li W, Seoane PR, Harnish PP, Fogelson L, Harris KR, Prasad PV. Magnetic resonance imaging of myocardial infarction using a manganese-based contrast agent (EVP 1001-1): preliminary results in a dog model. J Magn Reson Imaging. 2006 Feb;23(2):228-34.

Responsible Party:	Eagle Vision Pharmaceutical Corp. ( Peter Seoane, Ph.D. )
Study ID Numbers:	1001-1:201
Study First Received:	April 14, 2009
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00881075 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eagle Vision Pharmaceutical Corp.:

Magnetic resonance imaging
Heart diseases
myocardial infarction
contrast agents
manganese

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Manganese
Myocardial Infarction

Additional relevant MeSH terms:

Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on September 04, 2009