For years, chelation therapy, an alternative treatment for cardiovascular disease provided by scores of clinics around the country, has been assailed by some mainstream medical doctors as nothing more than a waste of money.

John Beale, Post-Gazette Dr. Ralph Miranda offers chelation therapy at his offices in Greensburg. Click photo for larger image. More information For more information, call the Wholistic Health Center's study coordinator Barbara Cassella at 724-838-7632. You can learn more about the study from the NCCAM Information Clearinghouse at 1-888-644-6226, nccam.nih.gov or www.clinicaltrials.gov. (For either site, type "chelation" in the search field).

Now the National Institutes of Health has launched the first large-scale, $30 million, randomized clinical trial that finally may provide concrete evidence of whether the therapy really works.

"We needed to have a definitive study," said Dr. Ralph Miranda, a staunch supporter who has offered chelation therapy in his practice since the early 1980s.

His Wholistic Health Center in Greensburg is one of more than 100 sites in the country, including three in Pennsylvania, participating in the five-year Trial to Assess Chelation Therapy, or TACT. The study is sponsored by the National Center for Complementary and Alternative Medicine and the National Heart, Lung and Blood Institute.

Miranda, former president of American College for Advancement in Medicine, has fended off critics and tried to clarify misinformation about the therapy that he contends is safe, effective, and far less expensive and invasive than bypass surgery for the 7 million Americans who have cardiovascular disease.

The treatment involves injecting the synthetic amino acid EDTA into the bloodstream that, proponents say, reduces damaging effects of oxygen and removes calcium to break up the plaque that clogs arteries.

The Food and Drug Administration has approved the therapy, pronounced key-LAY-shun, only to treat heavy metal poisoning, such as lead, in which EDTA -- for ethylene diamine tetraacetic acid -- latches onto heavy metals So they can be excreted through the urine.

More than 2,300 participants nationally will be recruited over the next two years (Miranda is hoping to recruit 25 to 30 volunteers). Half will receive a placebo. Because high doses of antioxidant vitamin and mineral supplements often are given during treatment to help repair damage to arteries, low and high doses of this regimen also will be tested.

The study is seeking nonsmoking men and women ages 50 and older who already have had heart attacks. Treatment involves 40 infusions of the standard chelation solution or a placebo given over 28 months. Participants will receive more than $4,000 in free treatments.

Peter Uram, 75, a retired Army lieutenant colonel who lives in Butler, recently signed up at the Greensburg site. He had a heart attack nearly six years ago, followed by quadruple bypass surgery, but lately hasn't been feeling well.

"Just in the last year, I've had shortness of breath. I don't want to do much anymore. I have difficulty cutting the grass, carrying groceries."

Another bypass is not an option, he said, because the veins in his legs cannot be used for the procedure. "If I want to live longer, what option do I have?"

Although he doesn't know whether he's getting the real treatment or the placebo, he said he feels more energized.

The study's eligibility criteria and treatment regimen are rigorous, Miranda said. Study leaders at Mount Sinai Medical Center-Miami Heart Institute must approve the eligibility of all participants.

But in the end, he hopes the study -- 20 times larger than any previous study on chelation therapy -- will be able to show once and for all whether the treatment works, is safe and is cost effective.