IU School of Medicine Participates in Nationwide Angina Pain Studies
INDIANAPOLIS - Angina at the very least is painful and at its worst
can be debilitating. For the millions of people who suffer daily from
angina, relief may come from two nationwide studies being conducted at
the Krannert Institute of Cardiology.
Krannert researchers at the Indiana University School of Medicine are
seeking participants for two clinical trials for people suffering chronic
angina pain. Krannert is one of 25 sites nationwide investigating an implantable
device to treat angina patients who have not responded to surgical or
other traditional medical therapy for the condition. The Stimulation Therapy
for Angina Refractory to Standard Treatments Interventions or Medication
(STARTSTIM) trial uses a device that is about the size of a pacemaker.
It is implanted in the upper abdominal or rear hip area and delivers electrical
stimulation to a nerve near the spine to block the angina pain.
The device received Food and Drug Administration approval in the 1980s
for treatment of back pain. Clinical trials now are underway to investigate
its potential use for pain relief for angina sufferers. If the neuro stimulator
is approved for angina, it would be the first electronic solution offered
in the United States. Neurostimulation for angina is a standard of care
in Europe.
The neurostimulator is implanted as an outpatient procedure. A battery
that is effective for five years powers the device. Replacement of the
battery is a relatively simple surgical procedure, researchers say.
An individual must have typical angina pain to be eligible for this trial,
which is funded by Medtronic, Inc. Trial participants must have failed
both drug and surgical methods of treatment for angina, and be able to
walk on a treadmill.
The other study is testing the effectiveness of a treatment for patients
with stable angina. The treatment is designed to promote the growth of
new blood vessels to improve circulation around the blockage in the artery
leading to the heart. It is the blockage that contributes to the angina
pain.
The trial, called Angiogenic Gene Therapy in Patients with Stable Angina
(AGENT 3) combines a modified version of a cold virus, known as an adenovirus,
with a gene therapy product that is designed to promote the growth of
new vessels. Angiogenesis is the natural process of growing new blood
vessels. The new vessels may provide alternate routes for oxygenated blood
to flow around narrow or blocked arteries due to atherosclerosis.
Patients enrolled in this trial must be between 30 and 75 years of age
and be able to walk on a treadmill. Patients cannot have a history of
cancer within the past 10 years.
If the therapy, developed by Berlex Laboratories, is effective, it is
hoped it could someday provide an additional option to the most common
treatments for coronary artery disease such as angioplasty, bypass surgery
or medication.
Angina affects nearly 6.5 million people in the United States, according
to statistics provided by the American Heart Association. An estimated
400,000 new cases of stable angina occur each year, the AHA reports.
Jeffrey Breall, M.D., director of interventional cardiology and the Clarian
Health Catherization Laboratory, is the local principal investigator for
both clinical trials. Douglas Zipes, M.D., Distinguished Professor Emeritus
and director of Krannert Institute and the IU School of Medicine Division
of Cardiology, is the national principal investigator of the STARTSTIM
trial.
For additional information on STARTSTIM, call Peggy Welker, BSN, RN,
research nurse coordinator, at 317-962-0070. For information on AGENT
3 clinical trial, call Julie Lacy, RN, BSN, research nurse coordinator,
at 317-962-0138.
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Media Contact: Mary Hardin
317-274-7722
mhardin@iupui.edu
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