Gadofosveset Trisodium for Heart Imaging Studies

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01853592
First received: May 2, 2013
Last updated: March 14, 2014
Last verified: February 2014
  Purpose

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
Obstructive Coronary Artery Disease
Coronary Arteriosclerosis
Coronary Artery Disease (CAD)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Pilot Dosing Study for Gadofosveset Trisodium (Ablavar) for Coronary Magnetic Resonance Angiography (MRA)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

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 & amp; contrast to noise ratios. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: March 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

A. Able to understand and sign informed consent.

B. Able to complete an MRI scan.

C. Age 18-45 years old.

D. eGFR greater than or equal to 60mL/min/1.73m(2) within 1 week prior to gadolinium injection.

E. 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.

F. 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:

A. Contra-indications to undergoing a MRA

Please review Radiology MRI section MRI safety questionnaire.

B. MRI with contrast within the last 6 months (self-reported) outside of our protocol.

C. Contra indications to receiving gadolinium-based contrast agent (specified here and on MRI safety questionnaire):

  1. Allergy to gadolinium-based contrast
  2. Labs:

i. Kidney and liver function above the upper limits of normal

ii. eGFR < 60ml/min/1.73m(2)

iii. Pregnancy test: positive

c. Acute renal failure, renal transplantation, curent dialysis treatment or hepatorenal syndrome

d. History of liver transplantation or severe liver disease

e. Severe Asthma

f. Hemoglobinopathies

g. History of multiple myeloma

h. History of significant allergic reaction to gadolinium-based contrast agents

i. Evaluated to be at increased risk for Nephrogenic Systemic Fibrosis (NSF).

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

  1. atrial fibrillation
  2. cardiac surgery
  3. cancer treatment
  4. 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:

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

F. Any other conditions that precludes safety for MRI per the researcher s evaluation.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01853592

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: David A Bluemke, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01853592     History of Changes
Other Study ID Numbers: 130098, 13-CC-0098
Study First Received: May 2, 2013
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Gadolinium Contrast
Cardiac MRI
MRA
MRI
MRI Safety

Additional relevant MeSH terms:
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on April 21, 2014