You will be provided with a reference and some statements. Please determine whether each statement is 'supported', 'unsupported', or 'unknown' with respect to the reference. Please note:
First, assess whether the reference contains any valid content. If the reference contains no valid information, such as a 'page not found' message, then all statements should be considered 'unknown'.
If the reference is valid, for a given statement: if the facts or data it contains can be found entirely or partially within the reference, it is considered 'supported' (data accepts rounding); if all facts and data in the statement cannot be found in the reference, it is considered 'unsupported'.

You should return the result in a JSON list format, where each item in the list contains the statement's index and the judgment result, for example:
[
    {
        "idx": 1,
        "result": "supported"
    },
    {
        "idx": 2,
        "result": "unsupported"
    }
]

Below are the reference and statements:
<reference>
BioLINCC: Trial to Assess Chelation Therapy 2 (TACT2)



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Studies

Trial to Assess Chelation Therapy 2 (TACT2)

Trial to Assess Chelation Therapy 2 (TACT2)

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Accession Number

HLB03062626a

Study Type

Clinical Trial

Collection Type

Open BioLINCC Study

See bottom of this webpage for request information

Study Period

October 2016 – June 2023

NHLBI Division

DCVS

Dataset(s) Last Updated

April 1, 2026

Clinical Trial URLs

NCT02733185

Primary Publication URLs

39141382

Related Studies

TACT

Consent

Commercial Use Data Restrictions

No

Data Restrictions Based On Area Of Research

No

Objectives

To evaluate whether edetate disodium-based chelation therapy reduces cardiovascular events in patients with diabetes and prior myocardial infarction.

Background

In 2013, the Trial to Assess Chelation Therapy (TACT) reported that edetate disodium (EDTA)–based chelation significantly reduced cardiovascular disease (CVD) events by 18% in patients with a prior myocardial infarction (MI). EDTA binds to heavy metals and eliminates them from the body via urinary excretion. Epidemiological studies have linked chronic exposure to heavy metals, especially lead and cadmium, in patients with CVD.

TACT2 was designed to replicate its predecessor study but involving patients with diabetes and prior MI to assess the relationship between the expected prognostic benefits and the depletion of body stores of lead with repeated EDTA infusions.

Participants

Eligible participants were 50 years of age or older, had diabetes, and had experienced an MI at least 6 weeks before recruitment. Exclusion criteria included individuals with baseline serum creatinine >2.0 mg/dL, HbA1C >11%, blood pressure greater than 160/100 mm Hg, or heart failure hospitalization within 6 months.

A total of 1,000 participants were enrolled. 499 patients were randomized to receive active EDTA chelation infusions and 501 were randomized to receive placebo infusions.

Design

TACT2 was a multicenter, double-masked 2 × 2 factorial trial. Participants were randomized to receive either 40 weekly infusions of EDTA or placebo. EDTA infusions consisted of up to 3 g of disodium EDTA, adjusted based on estimated creatinine clearance; 7 g of ascorbic acid; 2 g of magnesium chloride; 100 mg of procaine hydrochloride; 2500 U of unfractionated heparin; 2 mEq of potassium chloride; 840 mg of sodium bicarbonate; 250 mg of pantothenic acid; 100 mg of thiamine; 100 mg of pyridoxine; and sterile water to make up 500 mL of solution. The identical-appearing placebo solution consisted of 500 mL of normal saline and 1.2% dextrose (2.5 g total). During the infusion phase of the trial, all study participants received a daily low-dose vitamin regimen. The randomized oral vitamin regimen, composed of high-dose oral multivitamins and minerals or matching placebo caplets, was administered throughout the 60-month follow-up.

During the infusion period, participants completed physical exams. Participants were contacted to assess interval clinical events at 6 months and 12 months after randomization and continuing every 4 months for 5 years or until the end of the study.

The primary endpoint was a composite of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina.

Conclusions

Despite effectively reducing blood lead levels, EDTA chelation was not effective in reducing cardiovascular events in stable patients with coronary artery disease who have diabetes and a history of myocardial infarction.

Lamas GA, Anstrom KJ, Navas-Acien A, et al. Edetate Disodium-Based Chelation for Patients With a Previous Myocardial Infarction and Diabetes: TACT2 Randomized Clinical Trial. JAMA. 2024;332(10):794-803. doi:10.1001/jama.2024.11463

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</reference>

<statements>
1. The therapeutic hypothesis suggests that modulating these systemic metal concentrations—through dietary modification, oral or parenteral supplementation, pharmacologic chelation, or therapeutic phlebotomy—can reduce endothelial dysfunction, suppress oxidative stress, prevent pathologic calcification, and lower the incidence of adverse cardiovascular events
2. The initial Trial to Assess Chelation Therapy (TACT), published in 2013, evaluated 1,708 post-myocardial infarction patients aged 50 or older randomized to 40 infusions of a multi-component Na2EDTA solution or placebo, alongside high-dose oral multivitamins/minerals or placebo
3. TACT observed an 18% relative risk reduction in the primary composite endpoint of all-cause mortality, recurrent MI, stroke, coronary revascularization, or hospitalization for unstable angina (HR 0.82, 95% CI [0.69, 0.99], p=0.035)
4. To rigorously test this hypothesis, the multicenter Trial to Assess Chelation Therapy 2 (TACT2) was initiated in 2016 and published in 2024
5. TACT2 enrolled 1,000 patients across 88 clinical sites in the United States and Canada, enriching the study population for the subgroup showing the largest benefit in TACT: patients aged 50 or older with diabetes and a history of myocardial infarction
6. Participants were randomized to receive 40 weekly infusions of weight- and renal-adjusted \(\text{Na}_2\text{EDTA}\) chelation solution or matching placebo, combined with the factorial oral multivitamin and mineral regimen
7. However, this metal mobilization produced no discernible clinical benefit
8. Trial Name: **TACT2** (Chelation, 2024)
9. Target Cohort: Post-MI adults with Diabetes
10. Interventions Evaluated: 40 infusions \(\text{Na}_2\text{EDTA}\) vs. Placebo
11. Primary Outcome Endpoint: Composite of all-cause death, MI, stroke, revascularization, angina
12. Furthermore, because EDTA is cleared via glomerular filtration, heavy metal-chelate complexes directly challenge the renal tubular epithelium, risking acute tubular necrosis and necessitating frequent creatinine clearance monitoring and dose titration
13. The neutral results of TACT2 confirm that individual heavy metal extraction does not provide effective secondary prevention for ischemic cardiovascular disease
14. The hypothesis that non-targeted heavy metal chelation prevents macrovascular events in coronary disease has been disproven by the definitive results of TACT2
</statements>

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