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Angiogenesis
For Angina
(Growth
of New Blood Vessels on the Heart)
A Patients Guide
to the Clinical Trial with Fibroblast Growth Factor (rFGF-2) for
Coronary Artery Disease. |
Andrew Michaels, M.D.
Co-Director of the Cath Lab
415-514-2104
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UCSF-
Moffitt Long Hospital
505 Parnassus Avenue
San Francisco, CA 94143-0130 |
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This pamphlet is designed to help
explain what angiogenesis is and to determine if you may qualify
to participate in this clinical trial (study) at UCSF Stanford Health
Care. At USHC, we have many programs for patients who suffer from
angina and coronary artery disease. This clinical trial is one of
many options that you can ask our staff about. This clinical trial,
like most clinical trials, includes a placebo (inactive substance)
control group. Twenty-five percent (or 1 in 4 people) of individuals
will receive placebo. This study will require that all individuals
who qualify for study treatment undergo cardiac catheterization,
as the study drug or placebo will be given directly into the blood
vessels of the heart.
Atherosclerosis is a general term for
the buildup of fat & cholesterol on the inside lining of the blood
vessels of the heart (also in other areas of the body). Atherosclerosis
is the number one cause of coronary artery disease (disease of the
blood vessels of the heart). Angina occurs when the heart muscle does
not receive enough blood flow to meet its needs. The body responds
to the decreased blood flow by releasing substances that help grow
new blood vessels. The use of growth factors may help this process
occur more effectively.
What
is Angiogenesis?
Angiogenesis is the formation of new
capillary blood vessels, called collateral vessels, which form from
pre-existing blood vessels. Collateral vessels may grow on the heart
and actually bypass blocked blood vessels. These collateral vessels
are smaller, but more numerous, than the main blood vessels of the
heart. Collateral vessels can help offset some of the effects caused
by decreased blood flow.
What
are Growth Factors?
Growth factors are proteins (a major
source of building materials for body parts, such as muscles) which
are found in the body fluids and act as signals. Growth factors regulate
the amount of growth or lack of growth of specific body parts.
What
is FGF?
It has been discovered in preliminary
studies that animals given injections of the protein, fibroblast growth
factor (FGF), were able to grow their own bypasses. Hence, this treatment
may offer a potential benefit to humans with heart disease.
FGF is normally present in our bodies. In animal studies, it has been
introduced at a higher concentration and found to grow new blood vessels.
What
is rFGF-2?
Recombinant FGF-2 (rFGF-2) is a basic
fibroblast growth factor that is being used in this study. The r stands
for recombinant, which means that the growth factor is grown outside
of the human body with the help of yeast.
How
is rFGF-2 given?
rFGF-2 will be given in the cardiac catheterization
laboratory. Patients receiving the agent will have had a history of
heart disease and will have had cardiac catheterization and coronary
angiography in the past. To receive rFGF-2, you will have to have
the cardiac catheterization again. In this procedure, a small flexible
tube called a catheter is passed to the heart to look at the blood
vessels (coronary arteries) that provide the blood flow to the heart
muscle. rFGF-2 will be injected through the catheter directly into
the coronary arteries similar to the contrast used during angiography.
Who
can participate in this Clinical Trial (study)?
People with coronary artery disease (blockages
in the blood vessels that supply blood to the heart) who suffer from
angina, but for whom angioplasty (balloon compression of blockages)
or bypass surgery is not option. The goal of this trial is to see
if rFGF-2 is effective and safe in patients with angina.
How
can I find out more about this clinical trial?
First, you should speak to your doctor.
Your doctor may be able to answer some of your questions and help
determine if you are eligible. However, if your doctor would like
more information about the study, s/he may contact us. If you are
interested in participating, please call the number provided on the
cover sheet. You will be sent a packet with more information about
the study, including a questionnaire and a consent form. If you are
eligible you will be contacted by the study nurse and asked to come
to UCSF for the informed consent process, at which time your questions
will be answered. You may then decide whether you would like to participate
in the study.
Chiron Corporation, a biotechnology
company, is sponsoring this study.
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Text provided by Andrew Michaels,
M.D., Tony Chou, M.D., and Laura Kee, R.N., Ph.D.,
Division of Cardiology, University of California San Francisco
Copyright © 2001 All Rights Reserved
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