# Metals in the Trial to Assess Chelation Therapy 2 (TACT2M)

> **NIH NIH R01** · MOUNT SINAI MEDICAL CENTER (MIAMI BEACH) · 2020 · $1,000,000

## Abstract

Project Summary/Abstract
The main objectives of the Metals in the Trial to Assess Chelation Therapy 2 (TACT2M) are to evaluate
whether long-term edetate disodium (EDTA)-based chelation infusions can significantly reduce body lead and
cadmium levels and to determine whether this effect explains the reduction in major cardiovascular events
caused by EDTA chelation therapy. TACT2M is a companion study to TACT2 and will be integrated into the
clinical trial platform of TACT2, which will enroll 1200 post-MI patients with diabetes who are at least 50 years
old and have a creatinine of 2.0 mg/dL or less. TACT2, a replication study of TACT (referred to as TACT1), will
be a 2X2 factorial trial, randomizing patients to 4 groups, defined by both active vs placebo infusions and
active vs placebo oral multivitamins and multiminerals (OMVM). NCCIH has funded the UG3 1-year Planning
Phase of TACT2. The co-primary endpoints of TACT2M are: 1] the change in blood lead level from baseline to
infusion 40 or 1 year, whichever is first, and 2] the change in urine cadmium controlled for creatinine (Cd mcg/
gram creatinine) from baseline to infusion 40 or 1 year, whichever is first.
TACT2M has 3 Specific Aims: 1] Compare the change in metal internal dose (blood lead and urine cadmium)
in TACT2 participants, from baseline to infusion 40 or 1 year in the active infusion arm; 2] Evaluate whether
higher baseline metal internal dose (blood lead and urine cadmium) and the extent of depletion of those stores
identifies patients more likely to show benefit from chelation; 3] Collect a biorepository of specimens to support
future mechanistic work. Samples of whole blood and urine will be stored at -80ºC in a secured biorepository to
ensure their availability for the evaluation of future hypotheses that will be guided by the results of the trial.
Moreover, TACT2M represents a unique opportunity to assess the following Exploratory Aims: a] whether post-
infusion urine measurements, alone and in comparison to the corresponding pre-infusion measurements, have
clinical significance; b] whether OMVM interact with edetate disodium-mediated metal excretion; and c]
whether the suite of additional toxic and essential metals measured in blood and urine by the ICPMS analytic
technique used by the metals lab, many of which are not chelated by edetate disodium, have clinical
significance in preliminary testing.
In summary, TACT2M will assess whether metal chelation is a possible mechanism for improved clinical
outcomes in post-MI diabetic patients receiving edetate disodium chelation. The integration of TACT2M into
the existing TACT2 study is an efficient method to inform the treatment of patients with a history of MI and
diabetes.

## Key facts

- **NIH application ID:** 9688920
- **Project number:** 5R01AT009273-04
- **Recipient organization:** MOUNT SINAI MEDICAL CENTER (MIAMI BEACH)
- **Principal Investigator:** GERVASIO A LAMAS
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,000,000
- **Award type:** 5
- **Project period:** 2016-09-30 → 2022-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9688920

## Citation

> US National Institutes of Health, RePORTER application 9688920, Metals in the Trial to Assess Chelation Therapy 2 (TACT2M) (5R01AT009273-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9688920. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*