USDOE Human Subjects Research Database, Fiscal Year 1995

Washington University

Public Information Contact:

Ms. Joni Westerhouse
Medical Public Affairs
4444 Forest Park Ave, Box 8508
100 Sprout Road
St. Louis, MO 63108

Phone: 314-286-0120
Fax: 314-286-0199
Email: joniw@ibc.wustl.edu

Institutional Review Board (IRB):

Projects are approved by an IRB located at: Washington University.
The approving IRB operates under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
MPA number of the IRB: M-1123

Human Subjects Projects:

Number of Human Subjects Projects reported: 1

WUSM-93-DEFG0293ER61659

Detection and Assessment Using Positron Emission Tomography of Genetically Determined Defects in Myocardial Fatty Acid Utilization

Project Identifier: WUSM-93-DEFG0293ER61659

Project Title:

Detection and Assessment Using Positron Emission Tomography of Genetically Determined Defects in Myocardial Fatty Acid Utilization

Principle Investigator: Dr. Steven R. Bergmann

Project started in: 1993

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

DOE: Office of Health and Environmental Research (OHER)

Amount: $183,000 (Est.)

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: April 05, 1995
IRB Approval Number: 89-487

Number of Human Subjects in the Last Reporting Period for this Project: 11
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

Internal administration of radioactive substances to human subjects.

• For clinical research.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

The objective of this project is to determine whether inherited defects in myocardial fatty acid metabolism, which can lead to cardiomyopathy and sudden death, can be delineated with positron emission tomography (PET).

The research is not, at the current time, used for diagnosis or for decisions regarding treatment to individual subjects. Subjects are recruited who have been diagnosed as having inherited defects in fatty acid metabolism. Their siblings are also invited to participate. For subjects younger than 18 years of age, parental consent is obtained. For subjects 18 years of age or older, informed written consent is obtained.

For assessment of myocardial perfusion, oxygen-15 water is administered intravenously, and for delineation of vascular structures (subjects 18 years of age or older), oxygen-15 carbon monoxide is administered by inhalation. Regional myocardial perfusion is quantified using a one-compartment mathematical model. For assessment of regional myocardial oxygen consumption, subjects receive carbon-11 acetate intravenously, and for delineation of long-chain fatty acid metabolism, carbon-11 palmitate intravenously. Regional myocardial oxygen consumption and regional myocardial long-chain fatty acid metabolism are delineated with mathematical models. Blood samples are obtained for analysis of plasma substrates and radioactive metabolites.

All human subjects receive intravenous administration of ionizing radioisotopes, and subjects who are 18 years of age or older also receive ionizing radioisotopes by inhalation. All data are collected specifically for this project. Subjects are assigned a study number and are not identified by name. Data are maintained in the Principal Investigator's laboratory under lock and are not disseminated other than to collaborators or to appropriate government agencies. The procedure does involve administration of ionizing radiation. This amounts to 31% of the maximum permissible to radiation workers in subjects 18 years of age or older and 6% in subjects younger than 18 years of age. This amount of ionizing radiation is too small to have a directly measurable effect. Subjects undergo the research study after an overnight fast (which may be uncomfortable), have an intravenous catheter placed (associated also with discomfort and potential bruising, bleeding, or infection), and must lie in the PET scanner for a total of 1 1/2 to 2 hours (in 30 minute-intervals), which can be uncomfortable.