Gut Flora Modulation for The Prevention of Pci-Related Myocardial Injury - A Randomized, Placebo Controlled, Double Blind, Investigator-Initiated, Single Centre, Preliminary Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Incidence of abnormal c-TnI levels in patients undergoing coronary intervention
研究概览
简要总结
MYDA-MI study is a randomized, placebo controlled, double blind study performed in San Filippo Neri Hospital, Roma, Italy. The planned study duration is 18 months. The objectives are to assess the effects of pre-treatment with probiotic Ecoviesel on the incidence and magnitude of peri-procedural myocardial damage caused by coronary angioplasty in stable patients. 250 patients with chronic stable angina scheduled for a coronary angiography and possible ad hoc angioplasty will be randomized to receive pre-treatment with Ecoviesel sachets (each sachet contains 200 billions bacteria) or Placebo. The pre-treatment dosage will be 4 sachets of probiotic Ecoviesel or placebo for at least 2 weeks before the planned procedure. In patients undergoing angioplasty the same treatment will be continued for 4 weeks after PCI with secondary outcome measures performed at the end of this second stage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic stable angina scheduled for coronary angiography and possible ad hoc percutaneous coronary intervention
排除标准
- •Age >75 y.o
- •Diabetes requiring treatment
- •Abnormal c-TnI level before angiography
- •Immunodeficiency status
- •Need for oral vitamin K antagonists
- •Need for antibiotics
- •Use of antibiotics or probiotics within 4 weeks of enrollment
- •Cancer and diseases affecting 1 year prognosis
- •Participation in other clinical trials
研究组 & 干预措施
Placebo
Sachets with inactive substance indistinguishable from Ecoviesel
干预措施: Placebo (Other)
Dietary supplement - Probiotics
4 sachets of Ecoviesel (probiotics) per day for at least 2 weeks before undergoing a coronary angiography with possible ad hoc angioplasty; and 2 sachets of probiotic per day after angioplasty, if performed.
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Incidence of abnormal c-TnI levels in patients undergoing coronary intervention
时间窗: within 24 hours from coronary angioplasty
Percentage of patients with plasma c-TnI\>99th percentile of normality at least one blood sample among those drawn at 6, 12 a 24 h post-procedure
次要结局
- peak of c-TnI levels in patients undergoing coronary intervention(within 24 hours from coronary angioplasty)
- changes in hs-CRP in all patients after treatment phases(within 30 days of the invasive procedure)
- incidence of contrast-induced renal dysfunction in all patients(within 24 hours from coronary angioplasty)
- urine metabolomics in all patients after treatment phases(up to 30 days of the invasive procedure)
- in-hospital incidence of major adverse cardiac events in patients undergoing coronary intervention(up to 30 days)
研究者
Christian Pristipino
MD
San Filippo Neri General Hospital