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临床试验/NCT03956017
NCT03956017Unknown早期 1 期

Anti-oxidant Therapy and Postoperative Cardiac Events (ACE) Trial, Preoperative Intervention in Vascular Surgery

Minneapolis Veterans Affairs Medical Center1 个研究点 分布在 1 个国家目标入组 341 人开始时间: 2013年8月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
发起方
入组人数
341
试验地点
1
主要终点
Change in Troponin levels from baseline to peak

研究概览

简要总结

N Terminal (NT)-Pro b-type natriuretic peptide (BNP) levels provide incremental value in perioperative risk assessment prior to major non-cardiac surgery. The investigators will test whether pharmacologically lowering this biomarker with daily administration of CoQ10 for 3 days prior to elective vascular surgery will reduce adverse outcomes following the operation.

详细描述

Patients will be screened during their preoperative evaluation. Inclusion criteria include patients in need of an elective vascular operation. Exclusion criteria include urgent operation, known allergic reactions to CoQ10 and participation in another research study. Suitable participants will be randomly assigned to receive either CoQ10 (400 mg per day) versus Placebo for 3 days prior to surgery. A randomized, double blind trial will be used and a research pharmacist will guide the randomization process, blinded to clinical information. The primary end-point measures are BNP levels at 24 and 48 hours following the operation as well as the incidence of myocardial injury, defined by an elevated post-operative high-sensitivity troponin following high risk surgery. Secondary outcome measures include the magnitude of the troponin level, which is the change in the level compared with preoperative baseline troponin levels and adverse clinical cardiac outcomes during the hospitalization period, including death, non-fatal myocardial infarction, diagnosed by a cardiologist who is blinded to the treatment strategy and any coronary artery revascularization procedure. The study will be focused on 30-days following the vascular procedure but the investigators may plan to extend secondary outcome measures for 1 year post-randomization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • ELECTIVE HIGH RISK NON-CARDIAC SURGERY

排除标准

  • REACTION TO COQ10

研究组 & 干预措施

Ubiquinone

Experimental

Take oral tablets as directed (2x200 mg for 3 days prior to surgery)

干预措施: Ubiquinone (Drug)

Placebo

Placebo Comparator

Take oral tablets as directed (2x200 mg for 3 days prior to surgery)

干预措施: Placebo (Drug)

结局指标

主要结局

Change in Troponin levels from baseline to peak

时间窗: 48 hours

Change from baseline to peak

Cardiac Troponin levels following surgery

时间窗: 48 hours

Peak values

BNP levels following surgery

时间窗: 48 hours

Peak values

Number of participants with adverse cardiac outcomes following surgery

时间窗: 48 hours

Myocardial Infarction (MI) and death

次要结局

  • Number of participants who died(30 days)
  • Number of participants with new onset Atrial Fibrillation (A-Fib)(30 days)
  • Rate of readmission at 1 year following discharge(1 year)
  • Number of participants requiring coronary revascularization(30 days)
  • Number of participants with new heart failure(30 days)
  • Number of participants with infection(30 days)
  • Number of participants with a surgical graft failure(30 days)
  • Length of stay(30 days)

研究者

发起方
Minneapolis Veterans Affairs Medical Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Edward McFalls

CARDIOLOGIST

Minneapolis Veterans Affairs Medical Center

研究点 (1)

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