The National Center for Complementary and Alternative Medicine (NCCAM) and the National Heart, Lung, and Blood Institute (NHLBI), components of the National Institutes of Health (NIH), have launched the first large-scale clinical trial to determine the safety and efficacy of EDTA chelation therapy in individuals with coronary artery disease, the leading cause of death for both men and women in the United States.

The 5-year Trial To Assess Chelation Therapy (TACT) will involve over 2,300 patients at more than 100 research sites across the country.

Over 800,000 patient visits were made for chelation therapy in the United States in 1997. Chelation therapy involves the use of EDTA (ethylene diamine tetra-acetic acid), a synthetic amino acid that is administered intravenously (through the veins). EDTA, which effectively speeds removal of heavy metals and minerals such as lead, iron, copper, and calcium from the blood, 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 artery disease, some physicians and alternative medicine practitioners have recommended EDTA chelation as a way to treat this disorder.

Coronary artery disease (CAD) is a type of heart disease in which the coronary arteries (vessels that supply oxygen-carrying blood to the heart) become blocked by deposits of a fatty substance called plaque. As plaque builds, the arteries become narrower and less oxygen and nutrients are transported to the heart for proper function. CAD can lead to serious health problems such as angina (pain caused by insufficient oxygen-carrying blood reaching the heart), and heart attack.

There are standard and well-proven ways to reduce the risks or complications of CAD. These include stopping smoking and controlling high blood pressure and high blood cholesterol through lifestyle changes and medication. More invasive procedures are used to treat symptomatic CAD including balloon angioplasty (dilation of a blocked artery to open it up) or coronary artery bypass surgery (using arteries or veins from other areas of the body to create detours for blood flow around areas of blockage in the heart artery).