MYocardial DAmage AND MIcrobiota STUDY (MYDA-MI)

San Filippo Neri General Hospital

Status: Unknown

Conditions: Periprocedural Myocardial Damage; Chronic Stable Angina

Treatments: Dietary Supplement: Probiotic; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02908776

v216/6/2014

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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250 participants in 2 patient groups, including a placebo group

Dietary supplement - Probiotics

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

Sachets with inactive substance indistinguishable from Ecoviesel

Treatment:

Other: Placebo