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| Sponsor: | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Collaborator: |
National Center for Complementary and Alternative Medicine (NCCAM) |
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00044213 |
Purpose
The purpose of this study is to determine the safety and effectiveness of ethylene diamine tetra-acetic (EDTA) chelation therapy in individuals with coronary artery disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: EDTA chelation therapy Drug: Placebo infusions |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Trial to Assess Chelation Therapy (TACT) |
| Estimated Enrollment: | 1700 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Participants will receive 40 infusions of standard chelation solution.
|
Drug: EDTA chelation therapy
Participants will receive 40 infusions of standard chelation solution.
|
|
2: Placebo Comparator
Participants will receive 40 infusions of placebo.
|
Drug: Placebo infusions
Participants will receive 40 infusions of placebo.
|
EDTA chelation therapy involves repeated administrations of a synthetic amino acid to reduce atherosclerotic plaque and other mineral deposits throughout the cardiovascular system.
Participants will be randomly assigned to receive 40 infusions of either the standard chelation solution or placebo. The primary endpoint of this trial will be a composite of all cause mortality, myocardial infarction, stroke, hospitalization for angina and hospitalization for congestive heart failure.
The results of TACT will provide either a significant positive result or an informative null result upon which rational clinical decision-making and health policy can be based.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria for Participants:
Exclusion Criteria for Participants:
Contacts and Locations| Contact: NCCAM Clearinghouse | 1-888-644-6226 |
Hide Study Locations| United States, Alaska | |
| Alaska Cardiovascular Research Foundation | Active, not recruiting |
| Anchorage, Alaska, United States, 99508 | |
| United States, Arkansas | |
| Central Arkansas Veterans Healthcare System | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Patrick A. Golden | Recruiting |
| Fresno, California, United States, 93720 | |
| Phoenix Wellness Group | Recruiting |
| Napa, California, United States, 94558 | |
| Scripps Center for Integrative Medicine | Recruiting |
| La Jolla, California, United States, 92037 | |
| Mt Holistic Health Center | Recruiting |
| Danville, California, United States, 94526 | |
| United States, Colorado | |
| Aurora Denver Cardiology Associates | Recruiting |
| Denver, Colorado, United States, 80218 | |
| United States, Florida | |
| Innovative Research of West Florida | Recruiting |
| Largo, Florida, United States, 33770 | |
| Tru Med | Recruiting |
| Melbourne, Florida, United States, 32901 | |
| Mount Sinai Medical Center | Recruiting |
| Miami Beach, Florida, United States, 33140 | |
| Heart and Vascular Center for Research, Inc. | Recruiting |
| Sarasota, Florida, United States, 34239 | |
| Cardiology Consultants of South Florida | Active, not recruiting |
| Tamarac, Florida, United States, 33321 | |
| White-Wilson Medical Center | Recruiting |
| Fort Walton Beach, Florida, United States, 32547 | |
| Florida Cardiovascular Institute | Recruiting |
| Tampa, Florida, United States, 33609 | |
| Integrated Healing Arts | Recruiting |
| Bradenton, Florida, United States, 34210 | |
| Baptist Cardiac & Vascular Institute | Recruiting |
| Miami, Florida, United States, 33176 | |
| Tri-Health Alternative Medical Center | Recruiting |
| Mt. Dora, Florida, United States, 32757 | |
| Wellness Works | Recruiting |
| Brandon, Florida, United States, 33510 | |
| Life Family Practice Center for Complementary and Alternative Medicine | Active, not recruiting |
| The Villages, Florida, United States, 32159 | |
| Florida Medical Clinic, P.A. Clinical Research Division | Recruiting |
| Zephyrhills, Florida, United States, 33542 | |
| Hyperbaric Medicine Inc. | Recruiting |
| Ft. Walton Beach, Florida, United States, 32547 | |
| United States, Georgia | |
| Full Circle Medical Center | Recruiting |
| Fort Oglethorpe, Georgia, United States, 30742 | |
| Emory University School of Medicine | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: Janice Parrott 404-616-4445 jparrot@emory.edu | |
| Contact: Barbara Grant 404-616-4445 bpgrant@emory.edu | |
| United States, Indiana | |
| Crossroads Healing Arts LLC | Recruiting |
| Goshen,, Indiana, United States, 46528 | |
| Northwest Indiana Cardiovascular Physicians Inc. | Recruiting |
| Valparaiso, Indiana, United States, 46383 | |
| Intergrative Medical Center at Schneck Medical Center | Recruiting |
| Seymour, Indiana, United States, 47274 | |
| United States, Kansas | |
| Kansas University Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| The Center for the Improvement of Functioning International | Recruiting |
| Wichita, Kansas, United States, 67219 | |
| Contact: Michelle Barton 319-682-3100 mbarton@brightspot.org | |
| Principal Investigator: Ron Hunninghake, MD | |
| Sub-Investigator: Rebecca Kirby, MD | |
| United States, Louisiana | |
| Complementary Medical Services | Recruiting |
| Mandeville, Louisiana, United States, 70471 | |
| Crescent City Clinical Services | Recruiting |
| New Orleans, Louisiana, United States, 70125 | |
| United States, Maine | |
| Maine Integrative Wellness | Recruiting |
| Portland, Maine, United States, 04103 | |
| United States, Maryland | |
| Johns Hopkins Bayview Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| United States, Massachusetts | |
| Baystate Medical Center | Active, not recruiting |
| Springfield, Massachusetts, United States, 01199 | |
| Marino Center for Progressive Health | Recruiting |
| Cambridge, Massachusetts, United States, 02140 | |
| United States, Michigan | |
| The Preventive Medicine Center | Recruiting |
| Flint, Michigan, United States, 48503 | |
| Born Preventive Health Care Clinic | Recruiting |
| Grand Rapids, Michigan, United States, 49512 | |
| Parchment Family Practice | Recruiting |
| Kalamazoo,, Michigan, United States, 49004 | |
| Henry Ford Health System Preventative Cardiology Clay Ford Center for Athletic Medicine | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Rochester Center for Healthy Living | Recruiting |
| Rochester Hills, Michigan, United States, 48307 | |
| United States, Minnesota | |
| Mayo Clinic and Foundation Cardiovascular Health Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Berman Center for Outcomes and Clinical Research | Active, not recruiting |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, Missouri | |
| University of Missouri Hospital and Clinics | Active, not recruiting |
| Columbia, Missouri, United States, 65201 | |
| Preventive Medicine | Recruiting |
| St. Louis, Missouri, United States, 63146 | |
| United States, New Jersey | |
| Magaziner Center for Wellness | Recruiting |
| Cherry Hill, New Jersey, United States, 08003 | |
| Stockton Family Practice | Recruiting |
| Stockton, New Jersey, United States, 08559 | |
| Deborah Heart and Lung Center | Recruiting |
| Browns Mills, New Jersey, United States, 08015 | |
| Park Professional Building | Recruiting |
| Roselle Park, New Jersey, United States, 07204 | |
| Land Clinical Studies, LLC | Active, not recruiting |
| West Caldwell, New Jersey, United States, 07006 | |
| United States, New York | |
| Bronx-Lebanon Hospital Center | Recruiting |
| Bronx, New York, United States, 10457 | |
| Heart Care Center | Recruiting |
| East Syracuse, New York, United States, 13057 | |
| Schachter Center for Complementary Medicine | Recruiting |
| Suffern, New York, United States, 10901 | |
| Rhinebeck Health Center | Recruiting |
| Rhinebeck, New York, United States, 12572 | |
| NYU School of Medicine | Active, not recruiting |
| New York, New York, United States, 10016 | |
| The Gables Natural Medicines Center & Day Spa Family Health Services | Recruiting |
| Mayville, New York, United States, 14757 | |
| Staten Island Heart | Recruiting |
| Staten Island, New York, United States, 10305 | |
| Linchitz Medical Wellness, PLLC | Recruiting |
| Glen Cove, New York, United States, 11542 | |
| United States, North Carolina | |
| Integrative Medical Associates, PLLC | Recruiting |
| Tryon, North Carolina, United States, 28782 | |
| United States, Ohio | |
| University Hospitals of Cleveland | Active, not recruiting |
| Cleveland, Ohio, United States, 44106 | |
| The Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Celebration of Health Center | Recruiting |
| Bluffton, Ohio, United States, 45817 | |
| Upper Valley Family Care | Recruiting |
| Troy, Ohio, United States, 45373 | |
| Comprehensive Heart Care, Inc. | Recruiting |
| Toledo, Ohio, United States, 43606 | |
| Contact: Debra Braun 419-531-4235 chctoledo@sbcglobal.net | |
| Contact: Joanna Kunckel 419-531-4235 chctoledo@sbcglobal.net | |
| Principal Investigator: James Roberts, MD | |
| United States, Oklahoma | |
| COR Research | Recruiting |
| Oklahoma City, Oklahoma, United States, 73103 | |
| United States, Oregon | |
| Center for Environmental Medicine | Recruiting |
| Portland, Oregon, United States, 97220 | |
| Heart Institute of the Cascades | Active, not recruiting |
| Bend, Oregon, United States, 97701 | |
| United States, Pennsylvania | |
| Main Line Health Heart Center | Recruiting |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Wholistic Health Center | Recruiting |
| Greensburg, Pennsylvania, United States, 15601 | |
| Woodlands Healing Research Center | Recruiting |
| Quakertown, Pennsylvania, United States, 18951 | |
| United States, South Carolina | |
| Biogenesis Medical Center | Recruiting |
| Landrum, South Carolina, United States, 29356 | |
| United States, Tennessee | |
| The Castle Clinic, PLLC | Active, not recruiting |
| Johnson City, Tennessee, United States, 37601 | |
| Athens Surgery Clinic | Recruiting |
| Athens, Tennessee, United States, 37303 | |
| United States, Texas | |
| Tyler Total Wellness Center, PA | Active, not recruiting |
| Tyler, Texas, United States, 75703 | |
| Chelation Centers of Texas | Active, not recruiting |
| Texas City, Texas, United States, 77591 | |
| United States, Utah | |
| Freedom Center for Advanced Medicine | Recruiting |
| Provo, Utah, United States, 84604 | |
| United States, Virginia | |
| The Cardiovascular Group | Recruiting |
| Fairfax, Virginia, United States, 22031 | |
| Virginia Beach General Hospital | Recruiting |
| Virginia Beach, Virginia, United States, 23454 | |
| United States, Washington | |
| Hope Medical Holistic Clinic | Recruiting |
| Vancouver, Washington, United States, 98663 | |
| United States, Wisconsin | |
| Waters Preventive Medical Center, LTD | Recruiting |
| Wisconsin Dells, Wisconsin, United States, 53965 | |
| Care Foundation Inc. | Active, not recruiting |
| Wausau, Wisconsin, United States, 54401 | |
| Cardiovascular Research Foundation | Active, not recruiting |
| Franklin, Wisconsin, United States, 53132 | |
| Canada, British Columbia | |
| Cline Medical Centre | Recruiting |
| Nanaimo, British Columbia, Canada, V9R 2M9 | |
| Contact: Frank Pluta 250-753-3030 frank@clinemedical.com | |
| Principal Investigator: John C Cline, MD | |
| Canada, Nova Scotia | |
| The Wellness Centre | Recruiting |
| Port Hawkesbury, Nova Scotia, Canada, V4P 1B5 | |
| Contact: Ben Boucher, MD 902-625-3707 bodmanpub@ns.sympatico.ca | |
| Contact: Shelley MacNeil 902-625-3707 foster.macneil@ns.sympatico.ca | |
| Canada, Ontario | |
| Markham Integrative Medicine | Recruiting |
| Markham, Ontario, Canada, L3P 1Y8 | |
| Contact: John Gannage, MD 905-294-2335 mainstmed@on.aibn.com | |
| Contact: Shawna Thornhill 905-294-2335 shawna.mainstmed@on.aibn.com | |
| North Bay Complementary | Recruiting |
| North Bay, Ontario, Canada, P1B 4B8 | |
| Contact: Jean Aubry, MD 705-840-1212 bbrooks@cogeco.net | |
| Contact: Barbara Brooks, BA 705-840-1212 bbrooks@cogeco.net | |
| Chelox | Recruiting |
| Toronto, Ontario, Canada, M6H 3M2 | |
| Contact: Shmuel Bergman, MD 416-652-9862 chelox@rogers.com | |
| Contact: Ilana Bergman, RN 416-500-3240 chelox@rogers.com | |
| Anti-Aging & Family Wellness Clinic | Active, not recruiting |
| Madoc, Ontario, Canada, K0K 2K0 | |
| Chelation and Natural Therapy | Recruiting |
| Toronto, Ontario, Canada, M4W 3T1 | |
| Contact: Fred Hui, MD 416-920-4200 drhui@drhui.com | |
| Contact: Kathy Jafari 416-920-4200 ksjafari@gmail.com | |
| Jaconello Health Centre | Recruiting |
| Toronto, Ontario, Canada, M4K 3T1 | |
| Contact: Paul Jaconello, MD 416-463-2911 paul.jaconello@sympatico.ca | |
| Contact: Hildegard Beath, RN 416-463-2911 robertbeath@sympatico.ca | |
| Dr. C. Minielly | Recruiting |
| Smith Falls, Ontario, Canada, K7A 1C3 | |
| Contact: Clare Minielly, MD 613-283-7703 clareminielly@yahoo.com | |
| Contact: Betty Voteary 613-283-7703 clareminielly@yahoo.com | |
| Seekers Centre for Integrative Medicine | Recruiting |
| Ottawa, Ontario, Canada, K2E 1B3 | |
| Contact: Richard Nahas, MD 613-727-7246 richardnahas@gmail.com | |
| Contact: Shadi Nahas, PhD 613-727-7246 shadi@seekerscentre.com | |
| Chelation Center of Don Valley Inc. | Recruiting |
| Toronto, Ontario, Canada, M3C3F2 | |
| Chelation Center of Barrie, Inc. | Recruiting |
| Barrie, Ontario, Canada, L4N9T6 | |
| Canada, Quebec | |
| Montreal Heart Institute | Active, not recruiting |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Canada, Saskatchewan | |
| Saskatoon Chelation Centre | Recruiting |
| Saskatoon, Saskatchewan, Canada, S7M 5W1 | |
| Contact: Edward Nykiforuk, MD 306-652-2620 saskatoonchelation@shaw.ca | |
| Contact: Val Kalyn 306-931-8434 saskatoonchelation@shaw.ca | |
| Study Director: | Gervasio A Lamas, M.D. | Mount Sinai School of Medicine |
More Information
| Responsible Party: | Mount Sinai Medical Center ( Gervasio A. Lamas, MD ) |
| Study ID Numbers: | 654, U01 HL092607 |
| Study First Received: | August 22, 2002 |
| Last Updated: | August 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00044213 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |
