NIH National Study Testing Chelation Therapy for Heart Disease Under Way at International Medical Clinics (IMC) Atlanta, Georgia

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NIH National Study Testing Chelation Therapy for Heart Disease Under Way at International Medical Clinics (IMC) Atlanta, Georgia for people over 50 with a history of heart attack.

International Medical Clinics (IMC) is seeking men and women age 50 and older who have had a heart attack to join a National Institutes of Health (NIH) study on the effectiveness and safety of an investigational treatment for heart disease. The investigational treatment is a combination of chelation therapy and high-dose vitamin therapy compared with placebo (inactive treatment).

International Medical Clinics (IMC) is one of more than 100 medical institutions across the country selected to take part in the Chelation Therapy Study, the largest clinical research study to evaluate the therapy's effectiveness and safety as a treatment for heart disease.

Chelation (pronounced key-LAY-shun) therapy is an investigational therapy using a man-made amino acid, called EDTA (ethylene diamine tetra-acetic acid). It is added to the blood through a vein. A national research study is now testing whether chelation therapy is safe and effective for treating heart disease.

“Many people are considering using chelation therapy because of the belief that it may treat heart disease. However, this has not been scientifically proven. Past studies did not show benefit, but may have been too small to be conclusive," said Dr.Lisa Merritt. "We are committed to working with the NIH to find the answer to this important public health question."

The study is more than 20 times larger than any previous study of chelation therapy and is designed to be large enough to detect even moderate benefits associated with this therapy.

Coronary artery disease – the most common form of heart disease – is the leading cause of death of Americans, affecting more than 7 million people and killing 500,000 people each year. It occurs when the arteries that supply blood to the heart muscle (coronary arteries) become hardened and narrowed. The arteries harden and become narrow due to the buildup of fatty materials like cholesterol, called plaque, on the inner walls or lining of the arteries (atherosclerosis). Blood flow to the heart is reduced as plaque narrows the coronary arteries. This decreases the oxygen supply to the heart muscle. In a heart attack, a blood clot forms on the plaque and completely blocks flow through the artery.

Study participants will be assigned randomly (by chance, like flipping a coin) to receive a standardized chelation solution or a placebo (inactive) solution over a period of 28 months. Because chelation therapy may also remove important vitamins and minerals the body needs, all study participants will take low-dose vitamin and mineral supplements. In addition, some participants will receive a high-dose vitamin and mineral supplement. The study will also evaluate whether high-dose vitamins and minerals are helpful. Neither the participants nor the researchers administering the treatment will know which of the four treatment combinations is being given. Using this process to assign people to treatment groups means that the groups will be as similar as possible and that the treatments they receive can be compared objectively.

Those who join the study will be part of a nationwide effort to help the medical community find new and effective treatments for heart disease. In addition, their health will be closely monitored while they are enrolled in the study.

There are some potential risks and side effects to chelation therapy. The most common side effect is a burning sensation at the site where the EDTA is delivered into the veins. Rare side effects can include fever, headache, nausea, and vomiting. Even more rare are serious side effects that can include a sudden drop in blood pressure, abnormally low calcium levels in the blood, permanent kidney damage, and bone marrow depression (meaning that blood cell counts fall). Reversible injury to the kidneys, although infrequent, has been reported with EDTA chelation therapy. Other serious side effects can occur if EDTA is not administered by a trained health professional.

Those interested in learning more about the study can call 678-547-0000 or visit http://www.intlmedicalclinics.com

Contact: Lisa Merritt M.D.

International Medical Clinics (IMC)

TEL: (678)547-0000

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