Protocol Number: 06-H-0168

Title:

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

Number:

06-H-0168

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 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.

Patients 21 and older 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 again 24 hours and 72 hours 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. The patient lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. 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.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

No one will be excluded from this study based on race, gender, and ethnicity.

All subjects to be entered must:

- be at least 21 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:

Subjects will be excluded if they:

- have a positive pregnancy test (females)

- received an investigational drug or device within 30 days prior to administration of SeeMore

- have known hypersensitivity to granisetron or other selective serotonin 5HT(3) receptor blockers

- have a history of drug abuse or alcoholism

- have had a myocardial infarct, unstable angina, stroke of transient ischemic attach (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 QT(c) 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 (Systolic Blood Pressure greater than 140 or Diastolic BP greater than 90 consistently at baseline)

- have potassium, calcium or hematocrit values outside normal limits

- have altered (started, stopped or changed dosing of) either 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.

Special Instructions:

Currently Not Provided

Keywords:

Magnetic Resonance Imaging

Myocardial Infarction

Contrast Agents

Myocardial Function

Manganese

Recruitment Keyword(s):

Myocardial Infarction

MI

Condition(s):

Myocardial Infarction

Investigational Drug(s):

SeeMore (EVP-1001-1 Injection)

Investigational Device(s):

None

Intervention(s):

Drug: SeeMore (EVP-1001-1 Injection)

Supporting Site:

National Heart, Lung and Blood Institute

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Utter MF. The biochemistry of manganese. Med Clin North Am. 1976 Jul;60(4):713-27.

Brady TJ, Goldman MR, Pykett IL, Buonanno FS, Kistler JP, Newhouse JH, Burt CT, Hinshaw WS, Pohost GM. Proton nuclear magnetic resonance imaging of regionally ischemic canine hearts: effect of paramagnetic proton signal enhancement. Radiology. 1982 Jul;144(2):343-7.

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.

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