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

• 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
• 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

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）的试验是一个正在进行的多中心美国加拿大随机安慰剂 - 对照试验已经招募了1000名MI后糖尿病患者，并在阶乘设计中测试 是40种静脉内二酸酯基于基于disododium的输注还是安慰剂输注和高剂量口服 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2.5年的资金，以完成后续行动，结束，分析和 演讲/出版物。此TACT2延续建议由数据组成 由首席研究人员（PI）领导的杜克临床研究所（DCRI）的协调中心（DCC） Kevin J. Anstrom PhD和Daniel B. Mark MD，分包合同到临床协调中心（CCC） 位于迈阿密海滩的西奈山医疗中心（Gervasio A. Lamas MD，PI）和有毒金属和 纽约市哥伦比亚大学邮政公共卫生学院的生物官员核心实验室 （ANA NAVAS-ACIEN MD博士，PI）。 DCC及其分包合同将协调所有注册后的活动。 需要这种竞争性续订TACT2才能支持完成后续行动，数据库锁，分析的分析 研究假设，报告，发布和传播试验结果 CCC/DCC组合的TACT2针对此竞争更新的特定目标是： 一个。确定糖尿病患者和先验MI的基于螯合的策略是否改善了 无事件生存的主要复合终点； b。确定糖尿病患者和先前MI的基于螯合策略是否减少 导致死亡率； c。对TACT2螯合策略进行经济分析； d。确定金属螯合方案是否减轻了活动中的体金负担 治疗组，并确定治疗效果的大小是否更大 较大的金属负担； e。评估OMVM与安慰剂对临床结果的影响； f。维护一个生物座席，包括DNA，以解决未来的科学问题。 TACT2如果为正，则不仅会导致螯合成为临床实践和临床指南 但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。