Safety and Efficacy of SeeMore (TM) in Heart Patients

NCT00881075 | Completed Phase 2

• 1 other identifier: 1001-1:201
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myocardial Infarction

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  within 24 hours

Secondary Outcomes (1)

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

  within 1 hour

Study Arms (1)

SeeMore(TM)

EXPERIMENTAL

intravenous imaging agent for enhanced magnetic resonance imaging.

Drug: SeeMore(TM)

Interventions

SeeMore(TM) DRUG

single dose intravenous injectable

Also known as: EVP 1001-1

SeeMore(TM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eagle Vision Pharmaceutical Corp.: lead

Related Publications (3)

• 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.

  PMID: 6359418 BACKGROUND

• 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.

  PMID: 14501492 BACKGROUND

• 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.

  PMID: 16416440 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction; Heart Diseases

Interventions

EVP 1001-1

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2009
• First Posted: April 15, 2009
• Study Start: June 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: February 4, 2016

Record last verified: 2016-02