Trial to Assess Chelation Therapy 2 (TACT2) DCC Supplemental Bridge Funding

评估螯合疗法 2 (TACT2) DCC 补充过渡资金的试验

基本信息

批准号：
10393120
负责人：
Kevin J Anstrom
金额：
$ 107.56万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-09-30 至 2022-03-10
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10393120
关键词：
Age-Years Blood Canada Cardiac Cardiovascular Diseases Cardiovascular system Cessation of life Chelation Therapy Clinical Clinical Research Complementary Health Coronary Coronary Arteriosclerosis Creatinine DNA Data Analyses Data Coordinating Center Databases Diabetes Mellitus Disease-Free Survival Doctor of Philosophy Dose Enrollment Etiology Event Funding Future Guidelines Hospitalization Infusion procedures Institutes Integrative Medicine Intravenous Laboratories Medical center Metals Multivitamin Multivitamins/Minerals Myocardial Infarction National Center for Complementary and Alternative Medicine National Heart, Lung, and Blood Institute New York City Oral Outcome Patients Placebos Principal Investigator Public Health Public Health Schools Publications Publishing Randomized Recurrence Regimen Relative Risks Reporting Request for Applications Research Institute Risk Reduction Serum Site Stroke Subgroup Telephone Testing Time United States Food and Drug Administration United States National Institutes of Health Universities Urine active method base biobank chelation clinical practice clinically significant design economic evaluation follow-up improved insight mortality novel primary endpoint randomized placebo controlled trial response toxic metal treatment arm treatment effect treatment group treatment strategy trial comparing vitamin therapy

项目摘要

The Trial to Assess Chelation Therapy 2 (TACT2) is an ongoing multicenter US-Canada randomized placebo- controlled trial that has enrolled 1000 post-MI patients with diabetes and is testing, in a factorial design, whether 40 intravenous edetate disodium-based infusions or placebo infusions and high-dose oral multivitamins or oral placebo can significantly reduce recurrent ischemic cardiac events. The study has completed enrollment and seeks funding for 2.5 additional years to complete follow-up, closeout, analysis, and presentations/publications. This TACT2 continuation proposal consists of a single application by the Data Coordinating Center (DCC) at the Duke Clinical Research Institute (DCRI) led by Principal Investigators (PI) Kevin J. Anstrom PhD and Daniel B. Mark MD, with subcontracts to the Clinical Coordinating Center (CCC) at Mount Sinai Medical Center in Miami Beach FL (Gervasio A. Lamas MD, PI) and the Toxic Metals and Biorepository Core Laboratory at the Columbia University Mailman School of Public Health in New York City (Ana Navas-Acien MD PhD, PI). The DCC, and its subcontracts, will coordinate all post-enrollment activities. This competitive renewal of TACT2 is required to support completion of follow-up, database lock, analyses of study hypotheses, reporting, publication, and dissemination of trial results The combined CCC/DCC Specific Aims of TACT2 for this competitive renewal are to: a. Determine if the chelation-based strategy in patients with diabetes and prior MI improves the primary composite endpoint of event-free survival; b. Determine if the chelation-based strategy in patients with diabetes and prior MI reduces all- cause mortality; c. Perform an economic analysis of the TACT2 chelation strategy; d. Determine whether the metal chelation regimen reduces body metal burden in the active treatment group, and to determine whether treatment effect size is larger among those with larger metal burden; e. Assess the effect of OMVM vs. placebo on clinical outcomes; f. Maintain a biorepository including DNA for future scientific questions. TACT2, if positive, will not only result in the acceptance of chelation into clinical practice and clinical guidelines but also will provide important novel insights into the pathobiology and etiology of coronary artery disease.

评估螯合疗法 2 (TACT2) 的试验是一项正在进行的美国-加拿大多中心随机安慰剂试验对照试验招募了 1000 名心梗后糖尿病患者，并通过析因设计进行测试，是否 40 次依地酸二钠静脉输注或安慰剂输注和大剂量口服多种维生素或口服安慰剂可以显着减少复发性缺血性心脏事件。该研究有完成注册并寻求额外 2.5 年的资金以完成后续、收尾、分析和演示/出版物。此 TACT2 延续提案由数据中心的单个申请组成杜克临床研究所 (DCRI) 协调中心 (DCC)，由首席研究员 (PI) 领导 Kevin J. Anstrom 博士和 Daniel B. Mark 医学博士，与临床协调中心 (CCC) 签订了分包合同佛罗里达州迈阿密海滩的西奈山医疗中心（Gervasio A. Lamas MD、PI）以及有毒金属和纽约市哥伦比亚大学梅尔曼公共卫生学院生物样本库核心实验室（Ana Navas-Acien 医学博士、研究员）。 DCC 及其分包合同将协调所有注册后活动。 TACT2 的这种竞争性更新需要支持完成后续工作、数据库锁定、分析研究假设、报告、出版和传播试验结果 TACT2 此次竞争性更新的 CCC/DCC 综合具体目标是：一个。确定对患有糖尿病且既往患有心肌梗死的患者采用基于螯合的策略是否可以改善主要复合终点无事件生存期； b.确定对患有糖尿病和既往心肌梗死的患者采用基于螯合的策略是否可以减少所有- 导致死亡； c.对 TACT2 螯合策略进行经济分析； d.确定金属螯合方案是否可以减少活性物质中的身体金属负担治疗组，并确定治疗效果是否在治疗组中更大金属负荷较大； e.评估 OMVM 与安慰剂对临床结果的影响； f.维护一个包含 DNA 的生物储存库，以解决未来的科学问题。 TACT2，如果呈阳性，不仅会导致螯合被接受到临床实践和临床指南中而且还将为冠状动脉疾病的病理学和病因学提供重要的新见解。