Gadofosveset Trisodium for Heart Imaging Studies

NCT01853592 | Completed

• 2 other identifiers: 13009813-CC-0098
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Gadolinium Contrast; Cardiac MRI; MRA; MRI; MRI Safety

Outcome Measures

Primary Outcomes (1)

• 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

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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):
• Allergy to gadolinium-based contrast
• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Rhee CM, Bhan I, Alexander EK, Brunelli SM. Association between iodinated contrast media exposure and incident hyperthyroidism and hypothyroidism. Arch Intern Med. 2012 Jan 23;172(2):153-9. doi: 10.1001/archinternmed.2011.677.

  PMID: 22271121 BACKGROUND

• Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.

  PMID: 18046031 BACKGROUND

• Gerber TC, Carr JJ, Arai AE, Dixon RL, Ferrari VA, Gomes AS, Heller GV, McCollough CH, McNitt-Gray MF, Mettler FA, Mieres JH, Morin RL, Yester MV. Ionizing radiation in cardiac imaging: a science advisory from the American Heart Association Committee on Cardiac Imaging of the Council on Clinical Cardiology and Committee on Cardiovascular Imaging and Intervention of the Council on Cardiovascular Radiology and Intervention. Circulation. 2009 Feb 24;119(7):1056-65. doi: 10.1161/CIRCULATIONAHA.108.191650. Epub 2009 Feb 2. No abstract available.

  PMID: 19188512 BACKGROUND

• Ahlman MA, Raman FS, Pang J, Zemrak F, Sandfort V, Penzak SR, Fan Z, Liu S, Li D, Bluemke DA. Part 2 - Coronary angiography with gadofosveset trisodium: a prospective intra-subject comparison for dose optimization for 100 % efficiency imaging. BMC Cardiovasc Disord. 2016 Mar 22;16:58. doi: 10.1186/s12872-015-0152-8.

  PMID: 27004532 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• David A Bluemke, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 15, 2013
• Study Start: March 8, 2013
• Primary Completion: February 11, 2014
• Study Completion: December 13, 2016
• Last Updated: September 10, 2018

Record last verified: 2016-12-13

Locations

US (1)