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| ID | Type | Description | Link |
|---|---|---|---|
| U01HL092607 | U.S. NIH Grant/Contract | View source | |
| U01AT001156 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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, coronary revascularization, and hospitalization for angina.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDTA + high dose vitamin | Active Comparator | Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins. |
|
| EDTA + high dose vitamin placebo | Placebo Comparator | Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins. |
|
| EDTA placebo + high dose vitamin | Placebo Comparator | Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins. |
|
| EDTA placebo + high dose vitamin placebo | Placebo Comparator | Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDTA | Drug | Participants will receive 40 infusions of standard chelation solution. |
|
| Measure | Description | Time Frame |
|---|---|---|
| A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina. | Number of patients with events (composite of death from any cause, MI, stroke, coronary revascularization or hospitalization for angina) Events were centrally adjudicated where available; otherwise site reported events were used. | Measured over a maximum 5-year follow-up period- 55 month median |
| Measure | Description | Time Frame |
|---|---|---|
| A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke. | Number of patients with events (composite of cardiovascular death, non-fatal MI, non-fatal stroke) Events were centrally adjudicated where available; otherwise site reported events were used. | Measured over a maximum 5-year follow-up period- 55 month median |
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Inclusion Criteria for Participants:
Exclusion Criteria for Participants:
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| Name | Affiliation | Role |
|---|---|---|
| Gervasio A Lamas, M.D. | Icahn School of Medicine at Mount Sinai | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Arkansas Veterans Healthcare System | Little Rock | Arkansas | 72205 | United States | ||
| University of Arkansas for Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32446881 | Derived | Escolar E, Ujueta F, Kim H, Mark DB, Boineau R, Nahin RL, Goertz C, Lee KL, Anstrom KJ, Lamas GA. Possible differential benefits of edetate disodium in post-myocardial infarction patients with diabetes treated with different hypoglycemic strategies in the Trial to Assess Chelation Therapy (TACT). J Diabetes Complications. 2020 Aug;34(8):107616. doi: 10.1016/j.jdiacomp.2020.107616. Epub 2020 May 7. | |
| 24987051 | Derived | Mark DB, Anstrom KJ, Clapp-Channing NE, Knight JD, Boineau R, Goertz C, Rozema TC, Liu DM, Nahin RL, Rosenberg Y, Drisko J, Lee KL, Lamas GA; TACT Investigators. Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial. Circ Cardiovasc Qual Outcomes. 2014 Jul;7(4):508-16. doi: 10.1161/CIRCOUTCOMES.114.000977. |
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The primary analysis of the trial included 1708 patients who had been enrolled from September 2003 through October 2011 (median, 55 months)Participants were recruited at 134 sites in the US and Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | EDTA + High Dose Vitamin | Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins. |
| FG001 | EDTA + High Dose Vitamin Placebo | Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| EDTA Placebo | Drug | Participants will receive 40 infusions of EDTA placebo. |
|
| High Dose Vitamin | Dietary Supplement |
|
| High Dose Vitamin Placebo | Dietary Supplement |
|
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Mt Holistic Health Center | Danville | California | 94526 | United States |
| Patrick A. Golden | Fresno | California | 93720 | United States |
| Scripps Center for Integrative Medicine | La Jolla | California | 92037 | United States |
| Phoenix Wellness Group | Napa | California | 94558 | United States |
| Aurora Denver Cardiology Associates | Denver | Colorado | 80218 | United States |
| The Blend Institute | Bradenton | Florida | 34221 | United States |
| Wellness Works | Brandon | Florida | 33510 | United States |
| Innovative Research of West Florida | Clearwater | Florida | 33756 | United States |
| Hyperbaric Medicine Inc. | Fort Walton Beach | Florida | 32547 | United States |
| White-Wilson Medical Center | Fort Walton Beach | Florida | 32547 | United States |
| Tru Med | Melbourne | Florida | 32901 | United States |
| Baptist Cardiac & Vascular Institute | Miami | Florida | 33176 | United States |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Tri-Health Alternative Medical Center | Mt. Dora | Florida | 32757 | United States |
| Heart and Vascular Center for Research, Inc. | Sarasota | Florida | 34239 | United States |
| Florida Cardiovascular Institute | Tampa | Florida | 33609 | United States |
| Life Family Practice Center for Complementary and Alternative Medicine | The Villages | Florida | 32159 | United States |
| Florida Medical Clinic, P.A. Clinical Research Division | Zephyrhills | Florida | 33542 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30303 | United States |
| Full Circle Medical Center | Fort Oglethorpe | Georgia | 30742 | United States |
| Crossroads Healing Arts LLC | Goshen | Indiana | 46528 | United States |
| Integrative Medical Center at Schneck Medical Center | Seymour | Indiana | 47274 | United States |
| Northwest Indiana Cardiovascular Physicians Inc. | Valparaiso | Indiana | 46383 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| The Center for the Improvement of Functioning International | Wichita | Kansas | 67219 | United States |
| Complementary Medical Services | Mandeville | Louisiana | 70471 | United States |
| Maine Integrative Wellness | Portland | Maine | 04103 | United States |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
| Marino Center for Progressive Health | Cambridge | Massachusetts | 02140 | United States |
| Henry Ford Health System Preventative Cardiology Clay Ford Center for Athletic Medicine | Detroit | Michigan | 48202 | United States |
| The Preventive Medicine Center | Flint | Michigan | 48503 | United States |
| Born Preventive Health Care Clinic | Grand Rapids | Michigan | 49512 | United States |
| Parchment Family Practice | Kalamazoo | Michigan | 49004 | United States |
| Berman Center for Outcomes and Clinical Research | Minneapolis | Minnesota | 55404 | United States |
| Mayo Clinic and Foundation Cardiovascular Health Clinic | Rochester | Minnesota | 55905 | United States |
| University of Missouri Hospital and Clinics | Columbia | Missouri | 65201 | United States |
| Brian Dieterle, MD, PhD | Hollister | Missouri | 65673 | United States |
| Preventive Medicine | St Louis | Missouri | 63146 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Magaziner Center for Wellness | Cherry Hill | New Jersey | 08003 | United States |
| Park Professional Building | Roselle Park | New Jersey | 07204 | United States |
| Stockton Family Practice | Stockton | New Jersey | 08559 | United States |
| Heart Care Center | East Syracuse | New York | 13057 | United States |
| The Gables Natural Medicines Center & Day Spa Family Health Services | Mayville | New York | 14757 | United States |
| NYU School of Medicine | New York | New York | 10016 | United States |
| Rhinebeck Health Center | Rhinebeck | New York | 12572 | United States |
| Staten Island Heart | Staten Island | New York | 10305 | United States |
| Schachter Center for Complementary Medicine | Suffern | New York | 10901 | United States |
| Bronx-Lebanon Hospital Center | The Bronx | New York | 10457 | United States |
| Integrative Medical Associates, PLLC | Tryon | North Carolina | 28782 | United States |
| Celebration of Health Center | Bluffton | Ohio | 45817 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Comprehensive Heart Care, Inc. | Toledo | Ohio | 43606 | United States |
| Upper Valley Family Care | Troy | Ohio | 45373 | United States |
| COR Research | Oklahoma City | Oklahoma | 73103 | United States |
| St. Charles Health System | Bend | Oregon | 97701 | United States |
| Center for Environmental Medicine | Portland | Oregon | 97220 | United States |
| Wholistic Health Center | Greensburg | Pennsylvania | 15601 | United States |
| Woodlands Healing Research Center | Quakertown | Pennsylvania | 18951 | United States |
| Main Line Health Heart Center | Wynnewood | Pennsylvania | 19096 | United States |
| Biogenesis Medical Center | Landrum | South Carolina | 29356 | United States |
| Athens Surgery Clinic | Athens | Tennessee | 37303 | United States |
| The Castle Clinic, PLLC | Johnson City | Tennessee | 37601 | United States |
| Chelation Centers of Texas | Texas City | Texas | 77591 | United States |
| Freedom Center for Advanced Medicine | Provo | Utah | 84604 | United States |
| The Cardiovascular Group | Fairfax | Virginia | 22031 | United States |
| Virginia Beach General Hospital | Virginia Beach | Virginia | 23454 | United States |
| Hope Medical Holistic Clinic | Vancouver | Washington | 98663 | United States |
| Care Foundation Inc. | Wausau | Wisconsin | 54401 | United States |
| Waters Preventive Medical Center, LTD | Wisconsin Dells | Wisconsin | 53965 | United States |
| Cline Medical Centre | Nanaimo | British Columbia | V9R 2M9 | Canada |
| The Wellness Centre | Port Hawkesbury | Nova Scotia | V4P 1B5 | Canada |
| Chelation Center of Barrie, Inc. | Barrie | Ontario | L4N9T6 | Canada |
| Anti-Aging & Family Wellness Clinic | Madoc | Ontario | K0K 2K0 | Canada |
| Markham Integrative Medicine | Markham | Ontario | L3P 1Y8 | Canada |
| North Bay Complementary | North Bay | Ontario | P1B 4B8 | Canada |
| Seekers Centre for Integrative Medicine | Ottawa | Ontario | K2E 1B3 | Canada |
| Dr. C. Minielly | Smith Falls | Ontario | K7A 1C3 | Canada |
| Chelation Center of Don Valley Inc. | Toronto | Ontario | M3C3F2 | Canada |
| Jaconello Health Centre | Toronto | Ontario | M4K 3T1 | Canada |
| Chelation and Natural Therapy | Toronto | Ontario | M4W 3T1 | Canada |
| Chelox | Toronto | Ontario | M6H 3M2 | Canada |
| Saskatoon Chelation Centre | Saskatoon | Saskatchewan | S7M 5W1 | Canada |
| 24490264 | Derived | Lamas GA, Boineau R, Goertz C, Mark DB, Rosenberg Y, Stylianou M, Rozema T, Nahin RL, Lindblad L, Lewis EF, Drisko J, Lee KL; TACT (Trial to Assess Chelation Therapy) Investigators. Oral high-dose multivitamins and minerals after myocardial infarction: a randomized trial. Ann Intern Med. 2013 Dec 17;159(12):797-805. doi: 10.7326/0003-4819-159-12-201312170-00004. |
| 24254885 | Derived | Escolar E, Lamas GA, Mark DB, Boineau R, Goertz C, Rosenberg Y, Nahin RL, Ouyang P, Rozema T, Magaziner A, Nahas R, Lewis EF, Lindblad L, Lee KL. The effect of an EDTA-based chelation regimen on patients with diabetes mellitus and prior myocardial infarction in the Trial to Assess Chelation Therapy (TACT). Circ Cardiovasc Qual Outcomes. 2014 Jan;7(1):15-24. doi: 10.1161/CIRCOUTCOMES.113.000663. Epub 2013 Nov 19. |
| 23532240 | Derived | Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Lindblad L, Lewis EF, Drisko J, Lee KL; TACT Investigators. Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: the TACT randomized trial. JAMA. 2013 Mar 27;309(12):1241-50. doi: 10.1001/jama.2013.2107. |
| 22172430 | Derived | Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Drisko JA, Lee KL. Design of the Trial to Assess Chelation Therapy (TACT). Am Heart J. 2012 Jan;163(1):7-12. doi: 10.1016/j.ahj.2011.10.002. |
| FG002 | EDTA Placebo + High Dose Vitamin | Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins. |
| FG003 | EDTA Placebo + High Dose Vitamin Placebo | Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EDTA + High Dose Vitamin | Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins. |
| BG001 | EDTA + High Dose Vitamin Placebo | Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins. |
| BG002 | EDTA Placebo + High Dose Vitamin | Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins. |
| BG003 | EDTA Placebo + High Dose Vitamin Placebo | Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina. | Number of patients with events (composite of death from any cause, MI, stroke, coronary revascularization or hospitalization for angina) Events were centrally adjudicated where available; otherwise site reported events were used. | Posted | Number | participants | Measured over a maximum 5-year follow-up period- 55 month median |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke. | Number of patients with events (composite of cardiovascular death, non-fatal MI, non-fatal stroke) Events were centrally adjudicated where available; otherwise site reported events were used. | Posted | Number | participants | Measured over a maximum 5-year follow-up period- 55 month median |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EDTA + High Dose Vitamin | Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins. | 2 | 421 | 168 | 421 | ||
| EG001 | EDTA + High Dose Vitamin Placebo | Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins. | 0 | 418 | 201 | 418 | ||
| EG002 | EDTA Placebo + High Dose Vitamin | Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins. | 0 | 432 | 164 | 432 | ||
| EG003 | EDTA Placebo + High Dose Vitamin Placebo | Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins. | 2 | 437 | 185 | 437 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malaise | General disorders |
| |||
| Cardio-respiratory arrest | Cardiac disorders |
| |||
| Cardiac Failure Congestive | Cardiac disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| White Blood Cell Count Decreased | Investigations |
| |||
| Hypocalcaemia | Metabolism and nutrition disorders |
| |||
| Hypoglycaemia | Metabolism and nutrition disorders |
| |||
| Proteinuria | Renal and urinary disorders |
|
Enrolling Centers must abide by all TACT and NIH conflict of interest policies. Decisions about authorship on all multi-center publications resulting from research under this agreement will be made by the TACT Publica¬tions Committee prior to publication. No publications or other public disclosure shall be made until the TACT results are unblinded and results from all sites have been received and analyzed or TACT has been abandoned at all sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gervasio A. Lamas, M.D. | Mount Sinai Medical Center | 305-674-2162 | Gervasio.Lamas@msmc.com |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D004492 | Edetic Acid |
| D014815 | Vitamins |
| ID | Term |
|---|---|
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000078622 | Nutrients |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Male |
|
|
|