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Qualified
Patients Needed
TACT: the first large-scale, multicenter randomized trial to test whether
EDTA chelation therapy is beneficial for patients with coronary
heart disease. |
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What is EDTA chelation therapy?
How might EDTA chelation therapy work to clear blocked arteries?
How will the NIH study be conducted? |
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STUDY FACTS
- $30 million NIH-funded trial, led by Gervasio Lamas,
M.D., Director of Cardiovascular Research and Academic Affairs
at Mount Sinai Medical
Center in Miami Beach, Florida and Associate Professor of
Medicine at the University of Miami School of Medicine.
- 5-year, randomized,
double-blind, placebo-controlled, 2x2 factorial trial.
- 2,372
patients, aged 50 or older who have had a heart attack.
- More than
100 clinical sites across the country.
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Funded By:
- The U.S. National Institutes of Health (NIH)
- The National Center
for Complementary and Alternative Medicine (NCCAM)
- The National
Heart, Lung, and Blood Institute (NHLBI)
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| What is EDTA chelation therapy? |
Chelation is a chemical process in which a substance is used to bind
molecules, such as metals or mineral, and hold them tightly so
that they can be removed from a system, such as the body. In medicine,
chelation has been scientifically proven to rid the body of excess
or toxic metals. For example, a person who has lead poisoning may
be given chelation therapy in order to bind and remove excess lead
from the body before it can cause damage.
In the case of EDTA chelation therapy, the substance that binds
and removes metals and minerals is EDTA (ethylene diamine tetra-acetic
acid) a synthetic, or man-made, amino acid that is delivered
intravenously
(through the veins). EDTA was first used in the 1940s for the
treatment of heavy metal poisoning. EDTA chelation removes heavy
metals and
minerals from the blood, such as lead, iron, copper, and calcium,
and is approved by the U.S. Food and Drug Administration (FDA)
for use in treating lead poisoning and toxicity from other heavy
metals.
Although not approved by the FDA to treat coronary heart disease
(CHD), health care providers are using EDTA chelation as a way
to treat this disorder.
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| How might EDTA chelation therapy work to clear blocked arteries? |
Several theories have been suggested by those who recommend this
form of treatment. One theory suggests that EDTA chelation might
work by directly removing calcium found in fatty plaques that block
the arteries, causing the plaques to break up. Another is that
the process of chelation may stimulate the release of a hormone
that in turn causes calcium to be removed from the plaques or causes
a lowering of cholesterol levels. A third theory is that EDTA chelation
therapy may work by reducing the damaging effects of oxygen ions
(oxidative stress) on the walls of the blood vessels. Reducing
oxidative stress could reduce inflammation in the arteries and
improve blood vessel function. None of these theories has been
tested in a large-scale, randomized trial.
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| How will the NIH study be conducted? |
This randomized, double-blind, placebo-controlled trial will recruit
2,372 participants aged 50 years and older with a prior myocardial
infarction (heart attack) to test whether EDTA chelation therapy
and/or high-dose vitamin therapy is effective for the treatment
of CHD. This trial, with a total cost of approximately $30 million,
is about 20 times larger than the three previously published trials
of chelation therapy combined. It is designed to be large enough
to detect if there are any small or moderate benefits or risks
which would have important clinical and public health implications.
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For more information contact
Sangeeta Shah, M.D.
TACT Co-Investigator
(337) 235-1166
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Mount Sinai Medical Center Principal Investigator:
Gervasio Lamas, M.D., Miami Beach, FL
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