The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Systemic Inflammatory bio-markers
研究概览
简要总结
Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral supplementation will improve will improve systemic inflammation and patency of peripheral vascular intervention (PVI).
详细描述
The OMEGA-PVI trial is a double-blind, randomized (2:1 active:placebo), placebo-controlled trial with 30 patients aged ≥ 40 years with PAD. Eligible patients will be screened according to specified inclusion and exclusion criteria. All patients will be treated per our current practice as reflected in the American Heart Association Practice guidelines on PAD. n-3 PUFA supplementation will be achieved with 4 capsules of Pro-Omega twice daily (Nordic Naturals, Watsonville, California, USA), corresponding to a total of 4.4g/day given prior to and immediately after the operation. Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. The placebo group will take the same number of capsules containing inactive substance (soybean; Nordic Naturals), designed to be the same color and shape as the treatment capsules. Blood draws, questionnaires, and ultrasounds will be done periodically. Specific measurements will include established markers of inflammation and resolution of inflammation, as well as ultrasound measures of PVI patency. The study proposed here has the potential to provide important new insights on the role of nutritional interventions in PAD, as well as to improve outcomes related to surgical revascularization.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disabling claudication or CLI as indication for PVI (Rutherford Class II-V)
- •Objective evidence of PAD e.g. ABI < 0.9, TBI < 0.6 or absent pedal pulses
- •Currently not taking high-dose n-3 PUFA, as defined by >2 g/day
- •Able to provide written informed consent AND
- •Undergoing a PVI (catheter-based therapy) involving the aorto-iliac segment, superficial femoral artery or popliteal artery.
排除标准
- •Age < 40 or > 90 years
- •Undergoing open surgical revascularization
- •Evidence of active infection in limb or foot or osteomyelitis
- •Extensive tissue loss (Rutherford Class VI Disease)
- •Diagnosed hypercoagulable state
- •Non-atherosclerotic/aneurysmal disease as indication for procedure
- •Chronic liver disease or myopathy
- •End-stage renal disease (CKD 5)
- •Poorly controlled diabetes (HbA1C > 8%)
- •Recent other major surgery or illness within 6 weeks
- •Use of immunosuppressives or chronic inflammatory disorders
- •History of organ transplantation
- •Pregnancy or plans to become pregnant
- •Condition in which patient life expectancy is less than one year
结局指标
主要结局
Systemic Inflammatory bio-markers
时间窗: 6 months
Will reduce circulating pro-inflammatory markers (PIMs) and increase pro-resolution mediators (PRMs) assayed using targeted metabolo-lipidomics, increase PRM production within peripheral circulating monocytes.
次要结局
- Safety(6 months)