Henry Ford Health System is recruiting people with diabetes who have had a heart attack to participate in a National Institutes of Health (NIH) sponsored study looking at the benefits of removing toxic metals from the bloodstream.

The study follows another analysis that found a 41% reduction in recurrent heart events by chelation in patients with diabetes who already had sustained a heart attack.

Chelation is a process by which a medication can “grab” and remove toxic metal pollutants like lead or cadmium, which are present in the bloodstream of most people. Cadmium is a metal commonly found in industrial workplaces, including in some industrial paints and battery manufacturing processes. Lead, a soft, heavy metal, is most often ingested through chips and dust from old paint. Both are toxic to humans. Although the chelation process was developed in the 1950’s at Wayne State University for lead poisoning treatment, it is not a treatment for people exposed to high lead levels in their drinking water.

“We’re glad to help definitively answer the questions about the effects of chelation on those with established heart disease and diabetes,” says the new study’s principal investigator, Henry Ford Health System Associate Director of Preventive Cardiology, Jonathan Ehrman, Ph.D. “The first study had such promising results, we’re grateful to be able to continue that research on behalf of patients.”

Henry Ford Health System is currently recruiting patients for participation in the study, particularly African American patients, who are often under-represented in national studies, says Dr. Ehrman. Candidates must be 50 years of age or older, have diabetes and experienced a prior heart attack. Enrollees will receive $15 per visit to cover travel expenses. The study is being conducted at Henry Ford’s Center for Athletic Medicine in Midtown, Detroit; Henry Ford Medical Center-Livonia, and Henry Ford West Bloomfield Hospital.

Henry Ford Health System participated in the original study, a NIH-sponsored multicenter, double-blind safety and efficacy study called TACT. That study took place from 2002- 2012 and was conducted in 134 sites across the United States and Canada. During TACT, 1,708 heart attack patients were randomly assigned to receive 40 infusions of an edetate disodium-based chelation  solution or a placebo (inactive) infusion. Patients also received an oral vitamin and mineral regimen, or an oral placebo.

TACT demonstrated an 18% reduction in recurrent heart events by chelation in patients who already had sustained a heart attack. Recurrent heart events measured in the study were death, heart attack, stroke, heart bypass or stent, and hospitalization for angina (chest pains). In 633 patients with diabetes, there was an even larger benefit with a 41% reduction in recurrent heart events and a 43% reduction in deaths. Based on these results, the Mount Sinai and Duke scientists who conducted the trial felt that a repeat study was important to carry out.

“If TACT2 is positive, it will forever change the way we treat heart attack patients and view toxic metals in the environment,” said Gervasio Lamas, M.D., study chairman and chief of the Columbia Division of Cardiology at Mount Sinai Medical Center in Miami Beach, Florida.

Although not approved by the Food and Drug Administration for treating heart disease, some practitioners have used chelation therapy for nearly 60 years, even in the absence of clinical trial data supporting its use. Because of the lack of data, it has generally been believed by conventional medical practitioners and cardiologists to be without value, although TACT results suggest otherwise.

The National Center for Complementary and Integrative Health (NCCIH) of the National Institutes of Health (NIH) awarded $37 million to initiate the new trial. The trial is also co-funded by the National Heart, Lung and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Environmental Health Sciences.

Patients who are interested in participating in the study may contact the study team through http://www.tact2.org, by calling 313-972-4120, or may contact Heather Golden by email at hgolden1@hfhs.org.

 

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