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Safety and Efficacy of SeeMore (TM) in Heart Patients

Primary Purpose

Myocardial Infarction

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

SeeMore(TM)

About this trial

This is an interventional diagnostic trial for Myocardial Infarction focused on measuring Magnetic resonance imaging, Heart diseases, myocardial infarction, contrast agents, manganese

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SeeMore(TM)

Arm Description

intravenous imaging agent for enhanced magnetic resonance imaging.

Outcomes

Primary Outcome Measures

Examine the safety and tolerance of SeeMore following intravenous injection in patients known to have had a myocardial infarct

Secondary Outcome Measures

To assess the efficacy (enhancement features) of SeeMore for identifying myocardial infarction

Full Information

NCT ID

NCT00881075

First Posted

April 14, 2009

Last Updated

February 3, 2016

Sponsor

Eagle Vision Pharmaceutical Corp.

1. Study Identification

Unique Protocol Identification Number

NCT00881075

Brief Title

Safety and Efficacy of SeeMore (TM) in Heart Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eagle Vision Pharmaceutical Corp.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

Keywords

Magnetic resonance imaging, Heart diseases, myocardial infarction, contrast agents, manganese

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SeeMore(TM)

Arm Type

Experimental

Arm Description

intravenous imaging agent for enhanced magnetic resonance imaging.

Intervention Type

Drug

Intervention Name(s)

SeeMore(TM)

Other Intervention Name(s)

EVP 1001-1

Intervention Description

single dose intravenous injectable

Primary Outcome Measure Information:

Title

Examine the safety and tolerance of SeeMore following intravenous injection in patients known to have had a myocardial infarct

Time Frame

within 24 hours

Secondary Outcome Measure Information:

Title

To assess the efficacy (enhancement features) of SeeMore for identifying myocardial infarction

Time Frame

within 1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

12. IPD Sharing Statement

Citations:

PubMed Identifier

6359418

Citation

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. doi: 10.1016/s0001-2998(83)80048-8.

Results Reference

background

PubMed Identifier

14501492

Citation

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. doi: 10.1097/01.rli.0000077057.88108.3f.

Results Reference

background

PubMed Identifier

16416440

Citation

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. doi: 10.1002/jmri.20500.

Results Reference

background

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Safety and Efficacy of SeeMore (TM) in Heart Patients

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