Dr. Steven R. Bergmann
Cardiology - College of Physicans & Surgeons
PH 10 Stem-405
630 W. 168 St.
New York, NY 10032
Phone: 212-305-7594
Fax: 212-305-9882
Email: srb40@columbia.edu
Projects are approved by an IRB located at: Columbia 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: CU-93-62433
Project Title:
Detection and Assessment Using Position Emission Tomography of Defects in Myocardial Fatty Acid Utilization
Principal Investigator:
Dr. Steven R. Bergmann
Project started in: 1993
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 1
Protocol/Subproject # 1
Protocol/Subproject Identifier: 7874
IRB Review:
Type of Review: Full Board
Most Recent Approval: December 23, 1997
IRB Approval Number: 7874
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 14
Type of Human Subjects Involvement:
NOTE: Formerly project WUSM-93-61659. Principal Investigator relocated from Washington University.
A. The objective of this project is to delineate whether 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 cardiomyopathy. 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 the analysis of plasma substrates and radioactive metabolites.
D. Human subjects receive intravenous administration of ionizing radioisotopes, and subjects greater than 18 years of age also receive the 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 29% of the maximum permissible to radiation workers in subjects greater than 18 years of age and 4% 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, bleading, 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).