Chronic Stable Angina, Periprocedural Myocardial Damage
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
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.
OTHERPlacebo
Sachets of maltose, flavors and sylicium dioxide, indistinguishable from ecoviesel sachets.
Sponsors
MENDES S.A., Lugano, Switzerland
Università degli studi di Bologna, Italy
San Filippo Neri General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with chronic stable angina scheduled for coronary angiography and possible ad hoc percutaneous coronary intervention
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of abnormal c-TnI levels in patients undergoing coronary intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| peak of c-TnI levels in patients undergoing coronary intervention | within 24 hours from coronary angioplasty | peak plasma c-TnI concentration in blood samples drawn at 6, 12 a 24 h post-procedure |
| incidence of contrast-induced renal dysfunction in all patients | within 24 hours from coronary angioplasty | 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 |
| in-hospital incidence of major adverse cardiac events in patients undergoing coronary intervention | up to 30 days | Percentage of patients with in-hospital acute myocardial infarction, death or unplanned revascularisation |
| changes in hs-CRP in all patients after treatment phases | within 30 days of the invasive procedure | Change in plasma hs-CRP concentration at any visit |
| urine metabolomics in all patients after treatment phases | up to 30 days of the invasive procedure | Change in urine metabolomics at any visit |
Countries
Italy
Contacts
Primary ContactChristian Pristipino, MD
Outcome results
None listed