학술논문
Baseline characteristics including blood and urine metal levels in the Trial to Assess Chelation Therapy 2 (TACT2).
Document Type
Academic Journal
Author
Navas-Acien A; Department of Environmental Health Sciences Columbia University Mailman School of Public Health New York, NY. Electronic address: an2737@cumc.columbia.edu.; Santella RM; Department of Environmental Health Sciences Columbia University Mailman School of Public Health New York, NY.; Joubert BR; National Institute of Environmental Health Sciences, National Institutes of Health, Durham, NC.; Huang Z; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.; Lokhnygina Y; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC; Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC.; Ujueta F; Department of Medicine at Mount Sinai Medical Center, Miami Beach, FL.; Gurvich I; Department of Environmental Health Sciences Columbia University Mailman School of Public Health New York, NY.; LoIacono NJ; Department of Environmental Health Sciences Columbia University Mailman School of Public Health New York, NY.; Ravalli F; Department of Environmental Health Sciences Columbia University Mailman School of Public Health New York, NY.; Ward CD; Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA.; Jarrett JM; Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA.; Salazar AL; Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA.; Boineau R; National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD.; Jones TLZ; National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.; Mark DB; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.; Newman JD; New York University School of Medicine, New York, NY.; Nathan DM; Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston, MA.; Anstrom KJ; Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.; Lamas GA; Department of Medicine at Mount Sinai Medical Center, Miami Beach, FL; Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL.
Source
Publisher: Mosby Country of Publication: United States NLM ID: 0370465 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6744 (Electronic) Linking ISSN: 00028703 NLM ISO Abbreviation: Am Heart J Subsets: MEDLINE
Subject
Language
English
Abstract
Background: The reduction in cardiovascular disease (CVD) events with edetate disodium (EDTA) in the Trial to Assess Chelation Therapy (TACT) suggested that chelation of toxic metals might provide novel opportunities to reduce CVD in patients with diabetes. Lead and cadmium are vasculotoxic metals chelated by EDTA. We present baseline characteristics for participants in TACT2, a randomized, double-masked, placebo-controlled trial designed as a replication of the TACT trial limited to patients with diabetes.
Methods: TACT2 enrolled 1,000 participants with diabetes and prior myocardial infarction, age 50 years or older between September 2016 and December 2020. Among 959 participants with at least one infusion, 933 had blood and/or urine metals measured at the Centers for Diseases Control and Prevention using the same methodology as in the National Health and Nutrition Examination Survey (NHANES). We compared metal levels in TACT2 to a contemporaneous subset of NHANES participants with CVD, diabetes and other inclusion criteria similar to TACT2's participants.
Results: At baseline, the median (interquartile range, IQR) age was 67 (60, 72) years, 27% were women, 78% reported white race, mean (SD) BMI was 32.7 (6.6) kg/m2 , 4% reported type 1 diabetes, 46.8% were treated with insulin, 22.3% with GLP1-receptor agonists or SGLT-2 inhibitors, 90.2% with aspirin, warfarin or P2Y12 inhibitors, and 86.5% with statins. Blood lead was detectable in all participants; median (IQR) was 9.19 (6.30, 13.9) µg/L. Blood and urine cadmium were detectable in 97% and median (IQR) levels were 0.28 (0.18, 0.43) µg/L and 0.30 (0.18, 0.51) µg/g creatinine, respectively. Metal levels were largely similar to those in the contemporaneous NHANES subset.
Conclusions: TACT2 participants were characterized by high use of medication to treat CVD and diabetes and similar baseline metal levels as in the general US population. TACT2 will determine whether chelation therapy reduces the occurrence of subsequent CVD events in this high-risk population.
Clinical Trials Registration: ClinicalTrials.gov. Identifier: NCT02733185. https://clinicaltrials.gov/study/NCT02733185.
Competing Interests: Conflict of Interest Ana Navas-Acien, Regina M. Santella, Bonnie R. Joubert, Zhen Huang, Yuliya Lokhnygina, Francisco Ujueta, Irina Gurvich, Nancy J. LoIacono, Filippo Ravalli, Cynthia D. Ward, Jeffery M. Jarrett, Alfonsina De Leon Salazar, Robin Boineau, Teresa L.Z. Jones, Jonathan D. Newman, David M. Nathan and Gervasio A. Lamas report no conflicts of interest.Daniel B. Mark reports grants from HeartFlow and NovoNordisc, outside the scope of the submitted work; and consulting fees from Boehringer Ingelheim, Novartis and Celecor outside the scope of the submitted work.Kevin J. Anstrom reports funding from Merck and Bayer, outside the scope of the submitted work.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Methods: TACT2 enrolled 1,000 participants with diabetes and prior myocardial infarction, age 50 years or older between September 2016 and December 2020. Among 959 participants with at least one infusion, 933 had blood and/or urine metals measured at the Centers for Diseases Control and Prevention using the same methodology as in the National Health and Nutrition Examination Survey (NHANES). We compared metal levels in TACT2 to a contemporaneous subset of NHANES participants with CVD, diabetes and other inclusion criteria similar to TACT2's participants.
Results: At baseline, the median (interquartile range, IQR) age was 67 (60, 72) years, 27% were women, 78% reported white race, mean (SD) BMI was 32.7 (6.6) kg/m
Conclusions: TACT2 participants were characterized by high use of medication to treat CVD and diabetes and similar baseline metal levels as in the general US population. TACT2 will determine whether chelation therapy reduces the occurrence of subsequent CVD events in this high-risk population.
Clinical Trials Registration: ClinicalTrials.gov. Identifier: NCT02733185. https://clinicaltrials.gov/study/NCT02733185.
Competing Interests: Conflict of Interest Ana Navas-Acien, Regina M. Santella, Bonnie R. Joubert, Zhen Huang, Yuliya Lokhnygina, Francisco Ujueta, Irina Gurvich, Nancy J. LoIacono, Filippo Ravalli, Cynthia D. Ward, Jeffery M. Jarrett, Alfonsina De Leon Salazar, Robin Boineau, Teresa L.Z. Jones, Jonathan D. Newman, David M. Nathan and Gervasio A. Lamas report no conflicts of interest.Daniel B. Mark reports grants from HeartFlow and NovoNordisc, outside the scope of the submitted work; and consulting fees from Boehringer Ingelheim, Novartis and Celecor outside the scope of the submitted work.Kevin J. Anstrom reports funding from Merck and Bayer, outside the scope of the submitted work.
(Copyright © 2024 Elsevier Inc. All rights reserved.)