Clinical trial NCT02908776: MYocardial DAmage AND MIcrobiota STUDY
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Stable Angina
Periprocedural Myocardial Damage
Lead sponsor: San Filippo Neri General Hospital
Sponsor class: OTHER
Collaborators: name: MENDES S.A., Lugano, Switzerland
name: Università degli studi di Bologna, Italy
First posted: 2016-09-21
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of abnormal c-TnI levels in patients undergoing coronary intervention
timeFrame: within 24 hours from coronary angioplasty
Secondary outcomes:
measure: peak of c-TnI levels in patients undergoing coronary intervention
timeFrame: within 24 hours from coronary angioplasty
measure: incidence of contrast-induced renal dysfunction in all patients
timeFrame: within 24 hours from coronary angioplasty
measure: in-hospital incidence of major adverse cardiac events in patients undergoing coronary intervention
timeFrame: up to 30 days
measure: changes in hs-CRP in all patients after treatment phases
timeFrame: within 30 days of the invasive procedure
measure: urine metabolomics in all patients after treatment phases
timeFrame: up to 30 days of the invasive procedure
Other outcomes:
Locations:
city: Roma
country: Italy
facility: San Filippo Neri General Hospital
state: RM
Study officials:
affiliation: San Filippo Neri General Hospital
name: Christian Pristipino, MD
role: PRINCIPAL_INVESTIGATOR
References: