Dr. Steven R. Bergmann
Cardiology - College of Physicans & Surgeons
Ph3 - 342,
630 W. 168 st.
New York, NY 10032
Phone: 212-305-7594
Fax: 212-305-4648
Email: srb40@columbia.edu
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
Number of Human Subjects Projects reported: 1
Project Identifier: WUSM-93-61659
Project Title:
Detection and Assessment Using Position Emission Tomography of Genetically Determined Defects in Myocardial Fatty Acid Utilization
Principal Investigator:
Dr. Steven R. Bergmann
Principal Investigator's Institution: Columbia University
Project started in: 1993
Project Funding Information:
Project received funding in Fiscal Year 1996.
Project used human subjects in Fiscal Year 1996.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: March 06, 1996
IRB Approval Number: 89-0487
Number of Human Subjects who participated in this project/protocol during
02/01/96 - 02/01/97: 1
Type of Human Subjects Involvement:
A. The objective of this project is to delineate whether inherited defects in myocardial fatty acid metabolism, which can lead to cardiomyopathy and sudden death, can be delineated with positron emission tomography (PET).
B. 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 less than 18 years of age, parental consent is obtained. In subjects greater than 18 years of age, informed written consent is obtained.
C. For assessment of myocardial perfusion, oxygen-15 water is administered intravenously, and for delineation of vascular structures (in subjects greater than 18 years of age), 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.
D. Human subjects receive intravenous administration of ionizing radioisotopes, and in subjects greater than 18 years of age, 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 greater than 18 years of age and 6% in subjects less 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 potentially 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.