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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
250
Sachets with Streptococcus thermophilus DSM 32245: 70 billion, bifidobacteria (Bifidobacterium lactis DSM 32246, Bifidobacterium lactis DSM 32247) 40 billion, lactobacilli (Lactobacillus acidophilus DSM 32241, Lactobacillus helveticus DSM 29575, Lactobacillus paracasei DSM 32243, Lactobacillus plantarum DSM 32244, Lactobacillus brevis DSM 27961): 90 billion.
Sachets of maltose, flavors and sylicium dioxide, indistinguishable from ecoviesel sachets.
San Filippo Neri General Hospital
Roma, RM, Italy
RECRUITINGIncidence of abnormal c-TnI levels in patients undergoing coronary intervention
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
Time frame: within 24 hours from coronary angioplasty
peak of c-TnI levels in patients undergoing coronary intervention
peak plasma c-TnI concentration in blood samples drawn at 6, 12 a 24 h post-procedure
Time frame: within 24 hours from coronary angioplasty
incidence of contrast-induced renal dysfunction in all patients
Percentage of patients with plasma creatinine\>25% from baseline in least one blood sample among those drawn at 6, 12 a 24 h post-procedure
Time frame: within 24 hours from coronary angioplasty
in-hospital incidence of major adverse cardiac events in patients undergoing coronary intervention
Percentage of patients with in-hospital acute myocardial infarction, death or unplanned revascularisation
Time frame: up to 30 days
changes in hs-CRP in all patients after treatment phases
Change in plasma hs-CRP concentration at any visit
Time frame: within 30 days of the invasive procedure
urine metabolomics in all patients after treatment phases
Change in urine metabolomics at any visit
Time frame: up to 30 days of the invasive procedure
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