MYocardial DAmage AND MIcrobiota STUDY

Study Overview
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Brief Summary
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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.

Official Title
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Gut Flora Modulation for The Prevention of Pci-Related Myocardial Injury - A Randomized, Placebo Controlled, Double Blind, Investigator-Initiated, Single Centre, Preliminary Study

Conditions
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Chronic Stable Angina, Periprocedural Myocardial Damage

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary supplement - Probiotics<br>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. | Dietary Supplement: Probiotic<br>* 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.<br>* Other names: Ecoviesel;|
| Placebo Comparator: Placebo<br>Sachets with inactive substance indistinguishable from Ecoviesel | Other: Placebo<br>* Sachets of maltose, flavors and sylicium dioxide, indistinguishable from ecoviesel sachets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence 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 | within 24 hours from coronary angioplasty | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | up to 30 days | 
| changes in hs-CRP in all patients after treatment phases | Change in plasma hs-CRP concentration at any visit | within 30 days of the invasive procedure | 
| urine metabolomics in all patients after treatment phases | Change in urine metabolomics at any visit | up to 30 days of the invasive procedure |