MYocardial DAmage AND MIcrobiota STUDY

NCT02908776 | Unknown

• 1 other identifier: v216/6/2014
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stable Angina; Periprocedural Myocardial Damage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• peak of c-TnI levels in patients undergoing coronary intervention

  within 24 hours from coronary angioplasty

• incidence of contrast-induced renal dysfunction in all patients

  within 24 hours from coronary angioplasty

• in-hospital incidence of major adverse cardiac events in patients undergoing coronary intervention

  up to 30 days

• changes in hs-CRP in all patients after treatment phases

  within 30 days of the invasive procedure

• urine metabolomics in all patients after treatment phases

  up to 30 days of the invasive procedure

Study Arms (2)

Dietary supplement - Probiotics

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Sachets with inactive substance indistinguishable from Ecoviesel

Other: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

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.

Also known as: Ecoviesel

Dietary supplement - Probiotics

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic stable angina scheduled for coronary angiography and possible ad hoc percutaneous coronary intervention

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

San Filippo Neri General Hospital

Roma, RM, 00152, Italy

RECRUITING

MeSH Terms

Conditions

Angina, Stable

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Christian Pristipino, MD

  San Filippo Neri General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Pristipino, MD

CONTACT

+39060633062504; pristipino.c@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: September 21, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: January 1, 2020
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

IT (1)