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| Name | Class |
|---|---|
| MENDES S.A., Lugano, Switzerland | UNKNOWN |
| Università degli studi di Bologna, Italy | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | Sachets with inactive substance indistinguishable from Ecoviesel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Pristipino, MD | Contact | +39060633062504 | pristipino.c@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Christian Pristipino, MD | San Filippo Neri General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Filippo Neri General Hospital | Recruiting | Roma | RM | 00152 | Italy |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
|
| Placebo | Other | Sachets of maltose, flavors and sylicium dioxide, indistinguishable from ecoviesel sachets. |
|
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 |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |