HPC Readers Boost TACT Trial Enrollment

Readers of Holistic Primary Care are giving a big boost to the Trial to Assess Chelation Therapy (TACT), a landmark placebo-controlled study funded by the National Institutes of Health to determine whether chelation therapy can prevent heart attacks.

The Spring edition of Holistic Primary Care contained an article highlighting the importance of this multicenter study, and announcing the trial leaders’ plan to expand the number of participating clinics. (Visit www.holisticprimarycare.net to read the original article: NIH-Sponsored Chelation Trial Seeks Study Sites for Heart Disease Patients.) Within a few weeks of publication, TACT headquarters at Mount Sinai Medical Center, Miami Beach, received 17 calls or emails from physicians who said they’d seen the article and wanted to participate in the trial.

“This article generated a lot of calls and interest from doctors, and will likely lead to several new study sites enrolling patients for TACT around the country,” said Gervasio Lamas, MD, director of cardiovascular research at Mount Sinai, and principal investigator of the study. “I was very excited about this.” Dr. Lamas, who was not previously familiar with the publication, said the surge in calls was a surprising and much-needed shot in the arm for a trial that’s been almost 10 years in the making.

Laura Davila, Dr. Lamas’ assistant, said calls have come in from HPC readers in New York, Nevada, Seattle, Texas, Florida, California and Pennsylvania. She added that eight callers’ clinics are already being evaluated to see if they will meet the study’s criteria.

The TACT trial has a recruitment target of 2,372 post-infarction patients over age 50, who will be randomized to treatment with 40 infusions of either EDTA, the most commonly used chelation agent, or a saline placebo infusion. Patients in each study arm are further randomized to receive high or low-dose vitamin-mineral supplements, since most practitioners who do chelation therapy also incude supplementation as part of the protocol.

The primary endpoint for the TACT study is a composite of all cause mortality, myocardial infarction, stroke, hospitalization for angina, and hospitalization for congestive heart failure.

So far, investigators have enrolled 1,450 patients, many of whom are already in the follow-up phase. It will likely be several years before TACT yields its data, but involvement of HPC physician-readers will very likely help Dr. Lamas’ team move closer to the final enrollment goal, and thus closer to completion of the trial. “It definitely gave the study a needed burst of energy,” said Ms. Davila.

Physicians who do chelation and want to participate in TACT should feel free to contact Ms. Davila at the TACT office: 305-674-2162 and hit option 4, or email tactnih@msmc.com.