TACT – Trial to Assess Chelation Therapy

By Ron Hunninghake, M.D.

The Olive W. Garvey Center for Healing Arts has been selected as one of over 120 national test sites for TACT—Trial to Assess Chelation Therapy.

TACT is a nationwide clinical study involving over 1900 subjects being conducted by the National Institutes of Health. The study hopes to answer three fundamental questions:
• Is chelation therapy safe?
• Is it effective in reducing the incidence of clinical cardiovascular events?
• Does it improve quality-of-life and reduce health care costs?

Chelation is a medical/lifestyle therapy to improve general circulation. “Chele” is Greek for claw of the crab. Chelation grabs and removes heavy metals from the walls of arteries.
During chelation, an intravenous solution containing EDTA (Ethylene-Diamine-Tetraacetic-Acid) is infused over a three-hour period. EDTA is a man-made amino acid, patented in 1938 as possible antidote to chemical warfare agents. EDTA binds toxic heavy metals, including lead, cadmium, and aluminum, and to a minimal degree, mercury. This EDTA-metal complex is then excreted harmlessly through the kidneys.

The intent of chelation therapy is to reduce several factors that damage your arteries and cause vascular heart disease:
• Injury (homocysteine, bacteria, hemodynamic stress)
• Inflammation (WBCs and macrophages)
• Stiffening (free radical cross linking)
• Narrowing (plaque formation)
• Rupturing (instability of plaque)

Heavy metals catalyze free radical formation. Free radicals oxidize cholesterol. Oxidized cholesterol builds up in the walls of blood vessels, causing damage and inflammation. Damagedblood vessels form plaque. Plaque clogs arteries and can rupture suddenly, causing heart attacks and strokes.

Studies on chelation currently exist in the medical literature. Although these mostly case studies do show improved blood flow, reduction in symptoms, and the overall safety of the procedure, they do not meet scientific criteria as “evidence-based.”

TACT hopes to remedy this situation. As a 5-year, randomized, double-blind, placebo-controlled trial sponsored by NIH including National Institute for Complementary and Alternative Medicine and the National Heart, Blood, & Lung Institute, TACT will meet all evidence-based criteria. This study is being conducted in conjunction with Mt. Sinai Hospital of Miami and Duke University.

The Center is now calling for voluntary participants in this groundbreaking national study. If enough willing participants step forward, the decades old controversy surrounding chelation will end. Proponents and opponents of chelation alike are eager for a well conducted trial such as this, but without a sufficient number of eligible participants, it may never happen.

Who is eligible to participate at no cost? The inclusion criteria are simple and straightforward:
• You are 50 years of age and above
• The study invites both men and women
• You must have suffered a medically documented heart attack at least 6 weeks prior to the start of your involvement in the study

There are factors that may exclude your participation:
• History of having had chelation therapy within 5 years prior to the start of your involvement in this study
• History of allergic reactions to EDTA or any of the therapy’s components
• Coronary or carotid revascularization procedures within 6 months prior to study start or a scheduled revascularization
• History of cigarette smoking within 3 months prior to study start

•Childbearing potential

• History of liver disease
• Having diagnoses of additional medical conditions that could otherwise limit your 5- year survival

Before counting yourself out, please call and discuss these factors with a Center physician.

There are no costs for taking part in the study. You should continue to see your regular doctor. You will need  to maintain your health insurance to cover all medical care not included in the study.

Participation will always be your choice. The study team will work with you to schedule your visits at a time that works best for you. You can leave the study at any time.

Why participate? Help the medical community find new and effective treatments for heart disease. Join a nationwide effort to learn whether chelation therapy works. Know that your
health will be closely monitored (doctor appointment every 3months)while you are enrolled in the study.

TACT participants will be asked to come to The Center for their treatments once a week for 30 weeks. Then, they will have 10 more visits, between 2 weeks and 2 months apart. Each treatment will take at least 3 hours.

In conclusion, chelation is a medical/lifestyle therapy meant to improve circulation. Chelation is safe, under medical supervision. It is legal, cost-effective, and has many “side benefits.”

In the past 50 years, it is estimated that over a million people have undergone chelation. They have done so in spite of medical condemnation of
chelation. They have paid for chelation out of their own pockets because they experienced results. Were they wrong…or were they simply ahead of their time?

Now, with TACT, science can help us answer that question. As the study site’s principle investigator, I invite you to seriously consider being a part of this monumental scientific endeavor. Please help us gain a better understanding of the clinical value of chelation as a treatment for artery disease. Call today. I’ll be happy to call you back and discuss your participation in this historical event.