Trial to Assess Chelation Therapy 2 (TACT2) DCC Competing Renewal

评估螯合疗法 2 (TACT2) DCC 竞争更新的试验

• 批准号: 10590584
• 负责人: Kevin J Anstrom
• 金额: $ 212.07万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-30 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10590584
• 关键词: Age Years; Blood; Canada; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Chelation Therapy; Clinical; Clinical Research; Complementary and alternative medicine; 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; Intravenous; Laboratories; Medical center; Metals; Multivitamin; Multivitamins/Minerals; Myocardial Infarction; Myocardial Ischemia; National Center for Complementary and Integrative Health; 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; Vascularization; active method; 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

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（TACT 2）的试验是一项正在进行的多中心美国-加拿大随机安慰剂试验， 一项对照试验，招募了1000名MI后糖尿病患者，并在析因设计中测试， 无论是40次静脉注射依地酸二钠或安慰剂输注， 复合维生素或口服安慰剂可显著降低复发性缺血性心脏事件。该研究 完成入组并寻求额外2.5年的资金以完成随访、关闭、分析， 介绍/出版物。这TACT 2延续提案由数据的单一应用程序组成 由主要研究者（PI）领导的杜克临床研究所（DCRI）协调中心（DCC） Kevin J. Anstrom博士和丹尼尔B。Mark MD，分包给临床协调中心（CCC）， 位于佛罗里达州迈阿密海滩的西奈山医疗中心（Gervasio A.拉马斯医学博士，PI）和有毒金属， 位于纽约市的哥伦比亚大学梅尔曼公共卫生学院的生物储藏核心实验室 (Ana Navas-Acien MD PhD，PI）。DCC及其分包商将协调所有入组后活动。 需要TACT 2的竞争性更新，以支持完成随访、数据库锁定、 研究假设、试验结果的报告、出版和传播 TACT 2的CCC/DCC具体目标是： a.确定糖尿病和既往MI患者中基于螯合的策略是否改善了 无事件生存期的主要复合终点; B.确定糖尿病和既往MI患者中基于螯合的策略是否可减少所有- 造成死亡; C.对TACT 2螯合策略进行经济分析; D.确定金属螯合疗法是否能降低活性物质的体内金属负荷。 治疗组，并确定治疗效果大小是否大于那些 较大的金属负荷; e.评估OMVM与安慰剂对临床结局的影响; F.维持一个生物储存库，包括DNA，用于未来的科学问题。 TACT 2如果阳性，不仅会导致螯合作用被接受进入临床实践和临床指南， 而且将为冠状动脉疾病的病理生物学和病因学提供重要的新见解。