MYocardial DAmage AND MIcrobiota STUDY

Chronic Stable Angina Clinical Trial

— MYDA-MI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02908776
• Other study ID #: v216/6/2014
• Status: Recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: January 2020

Study information

• Verified date: April 2019
• Source: San Filippo Neri General Hospital
• Contact: Christian Pristipino, MD
• Phone: +39060633062504
• Email: pristipino.c[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina, Stable
• Chronic Stable Angina
• Periprocedural Myocardial Damage

Intervention

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

Locations

Country	Name	City	State
Italy	San Filippo Neri General Hospital	Roma	RM

Sponsors (3)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	urine metabolomics in all patients after treatment phases	Change in urine metabolomics at any visit	up to 30 days of the invasive procedure