UAMS, Veterans Health System Seek Participants For National Trial of Heart Attack Prevention Therapy
| LITTLE ROCK – The The Chelation Therapy Study is the largest clinical research study to evaluate the therapy’s effectiveness and safety as a treatment for heart disease. The treatment is a combination of chelation therapy and high-dose vitamin therapy compared with placebo (inactive treatment). UAMS and the Central Arkansas Veterans Healthcare System are among more than 100 medical institutions across the country selected for the Chelation Therapy Study. Chelation (pronounced key-LAY-shun) therapy is an investigational therapy – meaning it has not been approved for this use by the Food and Drug Administration – using a man-made amino acid, called EDTA (ethylene diamine tetra-acetic acid). It is injected into the blood through a vein. “Many people are considering using chelation therapy because of the belief that it may treat heart disease. However, this has not been scientifically proven,” said Y. Wady Aude, M.D., assistant professor of internal medicine in the UAMS College of Medicine, director of UAMS’ coronary care units and the principal investigator at UAMS and the VA for the trial. “Past studies did not show benefit, but may have been too small to be conclusive.” The study, expected to include more than 2,000 participants, 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 coronary arteries, which supply blood to the heart muscle, become hardened and narrowed because of buildup of fatty materials like cholesterol, called plaque, on the inner walls or lining of the arteries. Blood flow to the heart is reduced as plaque narrows the arteries, decreasing 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. “Individuals who join the study will be part of a nationwide effort to help the medical community find new and effective treatments for heart disease,” Aude said. Study participants will be assigned randomly to receive a standardized chelation solution or a placebo (inactive) solution for 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 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. There are some potential side effects to chelation therapy, the most common of which is a burning sensation at the site where the EDTA is delivered into the veins. The health of study participants will be closely monitored while they are enrolled in the study. Those interested in learning more about the study can contact the local trial investigators at 501-257-5843, by pager at 501-395-6911 or visit http://nccam.nih.gov/chelation. UAMS is the state’s only comprehensive academic health center, with five colleges, a graduate school, a medical center, five centers of excellence and a statewide network of regional centers. UAMS has about 2,170 students and 650 residents and is the state’s largest public employer with almost 9,000 employees. UAMS and its affiliates have an economic impact in UAMS centers of excellence are the