USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-80-001-H01

Project Title:

Cardiovascular Flow and Metabolism (see LBL-93-6-60 in 1994 database)

Principle Investigator: Dr. Thomas F. Budinger

Project started in: 1980

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.

Explanation:

Project continues to be funded by National Heart, Lung and Blood Institute (NHLBI). No funding is reported because no funds were spent on human subjects in FY 1995.

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: June 12, 1995
IRB Approval Number: 95-6-116

Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

Internal administration of radioactive substances to human subjects.

• For diagnostic research.

Chemical Substances:

Internal use of chemical substances (solid, liquid, or gas) in human subjects.

• For diagnostic research.

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

• Use of data collected from subjects specifically for this project.
• Use of existing data that were collected for another purpose or project.

(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])

OBJECTIVES

To demonstrate the value of quantitative information on specific coronary flow fields in patient diagnosis and management. To determine the influence of drugs and ischemic events on the sensitivity of rubidium as a flow marker to be sure that the myocyte and capillary membranes do not have an extraction markedly different from that of normal tissues at equivalent flow values. Secondly, we wish to determine how well we can actually quantitate flow by kinetic analysis for the time course of activity in the ventricle blood pool and regions of the myocardium using non-invasive positron emission tomography (PET) methods developed during the last 10 years in our laboratory. Societal benefits from this research may include earlier detection of coronary artery disease in the future.

METHODOLOGY

Two injections of 60 mCi are planned with allowance for a 3rd injection if necessary. Patients will receive constant monitoring of blood pressure and EKG while under doses of vasodilators, adenosine and dipyridamole. Aminophylline will be used to reverse the effects of dipyridamole, if necessary. Before and after the use of the vasodilators, PET scan imaging studies will be done.

IONIZING RADIATION, RADIOACTIVE SUBSTANCES, OR CHEMICAL SUBSTANCES

Rubidium-82 as a radiotracer. Vasodilators adenosine and dipyridamole.

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

PET scan risks include: venous catheter (bruising, faintness); radiation (equivalent to back x-ray). The risk of using vasodilators is that common to their clinical use as diagnostic aids (temporarily lowered blood pressure possibly causing dizziness, flushing, headaches, and/or mild chest pain similar to angina).