MYocardial DAmage AND MIcrobiota STUDY (MYDA-MI)

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

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 Overview

• Status: Unknown
• Conditions: Chronic Stable Angina; Periprocedural Myocardial Damage
• Intervention / Treatment: Dietary supplement: Probiotic; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Pristipino, MD; Phone Number: +39060633062504; Email: pristipino.c@gmail.com

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00152
      • Recruiting
      • San Filippo Neri General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: San Filippo Neri General Hospital
• Collaborators: MENDES S.A., Lugano, Switzerland; Università degli studi di Bologna, Italy
• Investigators: Principal Investigator: Christian Pristipino, MD, San Filippo Neri General Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: September 17, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable
• Other Study ID Numbers: v216/6/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED