Gadofosveset Trisodium for Heart Imaging Studies

Sponsor

National Institutes of Health Clinical Center (CC) (NIH)

Overall Status

Completed

CT.gov ID

NCT01853592

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

45.2

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:

Magnetic resonance imaging (MRI) is type of imaging study that uses magnetic fields and radio waves to take pictures of the body. To help the images show up more clearly, a contrast agent is injected into a vein. Researchers are interested in finding contrast agents that can help show problems with the blood vessels around the heart. They want to test an agent called Gadofosveset Trisodium to see how it works in MRI scans.

Objectives:

To test the effectiveness of Gadofosveset Trisodium as a contrast agent in heart MRI scans.

Eligibility:

Healthy volunteers between 18 and 45 years of age.

Design:

Participants will be screened with a physical exam and medical history. They will provide blood samples before the scanning sessions.
Participants will have an MRI scan after the screening visit. They will have a dose of the contrast scan before the study.
Participants will return for one additional MRI scan within 1 to 2 months of each scan. Different doses of the contrast agent will be used for each scan.
An additional blood sample will be collected within 1 week of the second MRI scan.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Coronary Artery Disease Coronary Arteriosclerosis Coronary Artery Disease (CAD)

Detailed Description

The purpose of this study is to determine if the diagnostic quality of contrast-enhanced coronary magnetic resonance angiography (MRA) is improved by using a higher versus a lower dose of a gadolinium-based contrast agent. We will compare two doses of an intravascular contrast agent (Gadofosveset, 0.03 and 0.06 mmol/kg) in this pilot dosing study. Healthy participants will be recruited who do not have a clinical indication for MR angiography but do have safety clearance for IV gadolinium contrast and MR scanning.

Subjects will be evaluated in order to determine if the signal to noise ratio (SNR) and contrast to noise ratio (CNR) of the coronary arteries is increased for the higher dose contrast agent. Parameters will be compared with paired t-testing for significance.

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Time Perspective:

Prospective

Official Title:

A Pilot Dosing Study for Gadofosveset Trisodium (Ablavar) for Coronary Magnetic Resonance Angiography (MRA)

Study Start Date :

Mar 8, 2013

Actual Primary Completion Date :

Feb 11, 2014

Actual Study Completion Date :

Dec 13, 2016

Outcome Measures

Primary Outcome Measures

To evaluate 0.06 mmol/kg Gadofosveset trisodium compared to 0.03 mmol/kg Gadofosveset trisodium for the diagnostic quality of MRA of the coronary arteries, as measured by changes in signal to noise & contrast to noise ratios. [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

INCLUSION CRITERIA:

Able to understand and sign informed consent.
Able to complete an MRI scan.
Age 18-45 years old.
eGFR greater than or equal to 60mL/min/1.73m(2) within 1 week prior to gadolinium injection.
NIH employees may be involved and NIH requirements will be followed as laid out in NIH Policy Manual 2300-630-3 - Leave Policy for NIH Employees Participating in NIH Medical Research Studies.
Willing to travel to the NIH for scheduled follow-up visits and scans as well as potential repeat scans in the event of sub-optimal scanning.

EXCLUSION CRITERIA:

Individuals will be excluded from the study if they have:

Contra-indications to undergoing a MRA

Please review Radiology MRI section MRI safety questionnaire.

MRI with contrast within the last 6 months (self-reported) outside of our protocol.
Contra indications to receiving gadolinium-based contrast agent (specified here and on

MRI safety questionnaire):

Allergy to gadolinium-based contrast
Labs:

Kidney and liver function above the upper limits of normal

eGFR < 60ml/min/1.73m(2)
Pregnancy test: positive

Acute renal failure, renal transplantation, curent dialysis treatment or hepatorenal syndrome
History of liver transplantation or severe liver disease
Severe Asthma
Hemoglobinopathies
History of multiple myeloma
History of significant allergic reaction to gadolinium-based contrast agents
Evaluated to be at increased risk for Nephrogenic Systemic Fibrosis (NSF).

D. Current written (or self-reported) record of:

atrial fibrillation
cardiac surgery
cancer treatment
other comorbid conditions that otherwise indicates the participant has renal function that may deteriorate between study procedures due to the participant s underlying medical condition or that would not allow the study subject to complete the protocol.

E. Current written (or self-reported) record of active:

Clinically diagnosed angina, heart failure, and/or clinically significant electrical conduction abnormality in the heart.
Pregnancy or lactation
Mental, neurologic or social condition preventing understanding of the rationale, procedures, risks and potential benefits associated with the trial
Paralyzed hemidiaphragm
Over 400 lbs and/or a body circumference that prevents adequate MRI gantry insertion.
Unable to lay flat in the scanner
Claustrophobia otherwise requiring anesthesia or sedation to undergo MRI.
Participant is not able to undergo intravenous line placement and/or refuse gadolinium contrast.