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MYDA-MI: MYocardial DAmage AND MIcrobiota STUDY

Sponsor
San Filippo Neri General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02908776
Collaborator
MENDES S.A., Lugano, Switzerland (Other), Università degli studi di Bologna, Italy (Other)
250
Enrollment
1
Location
2
Arms
40
Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Probiotic
  • Other: Placebo
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2019
Anticipated Study Completion Date :
Jan 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Dietary Supplement: Probiotic
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.
Other Names:
  • Ecoviesel

    		•
    Placebo Comparator: Placebo

    Sachets with inactive substance indistinguishable from Ecoviesel

    Other: Placebo
    Sachets of maltose, flavors and sylicium dioxide, indistinguishable from ecoviesel sachets.

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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

    2. 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

    3. 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

    4. 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

    5. urine metabolomics in all patients after treatment phases [up to 30 days of the invasive procedure]

      Change in urine metabolomics at any visit

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 San Filippo Neri General Hospital Roma RM Italy 00152

    Sponsors and Collaborators

    • San Filippo Neri General Hospital
    • MENDES S.A., Lugano, Switzerland
    • Università degli studi di Bologna, Italy

    Investigators

    • Principal Investigator: Christian Pristipino, MD, San Filippo Neri General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christian Pristipino, MD, San Filippo Neri General Hospital
    ClinicalTrials.gov Identifier:
    NCT02908776
    Other Study ID Numbers:
    • v216/6/2014
    First Posted:
    Sep 21, 2016
    Last Update Posted:
    Apr 4, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Angina, Stable

    Study Results

    No Results Posted as of Apr 4, 2019