MYocardial DAmage AND MIcrobiota STUDY
Unknown statusNot applicableNCT02908776
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Gut Flora Modulation for The Prevention of Pci-Related Myocardial Injury - A Randomized, Placebo Controlled, Double Blind, Investigator-Initiated, Single Centre, Preliminary Study
- Conditions
- Chronic Stable Angina
- Periprocedural Myocardial Damage
- Interventions
- Dietary supplement: Probiotic
- Other: Placebo
- Sponsor
- San Filippo Neri General Hospital
- Collaborators
- MENDES S.A., Lugano, Switzerland; Università degli studi di Bologna, Italy
- Start date
- 2016-09
- Primary completion
- 2019-09
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02908776