An interventional study of Probiotic and Placebo in Chronic Stable Angina and Periprocedural Myocardial Damage, sponsored by San Filippo Neri General Hospital. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-04-04.
Sponsored by San Filippo Neri General Hospital · Not applicable, Interventional, and Prevention
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Among 23 studies in Angina, Stable with a site in Italy — 3 open to participants now, 4 under way, none of them phase 3. Angina, Stable · Italy.
Among the 23 studies in Angina, Stable with a site in Italy, this one is the 10th largest by planned enrollment of the 17 interventional ones that give a count, is one of 3 that started in 2016, is one of 10 with no phase, and was the 14th registered.
343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.
Browse Angina, Stable studies →3 of the 23 studies in Angina, Stable with a site in Italy are open now. Recruiting first, the newest first:
IRCCS Ospedale San Raffaele · Sites in Italy
Ages 18+
Catholic University of the Sacred Heart · Sites in Italy
Ages 18+
GE Healthcare · Sites in Italy
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 39 Angina, Stable studies recruiting now, 33 (85%) set no upper age limit and 2 (5%) stop at 75 or younger; 2 take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 3 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 250 is above the median of 150 across 230 interventional studies indexed under Angina, Stable.
Median enrollment 323 across the 17 interventional studies, 600 across the 6 observational. Of the 11 that completed or were terminated, 1 (9%) have results posted.
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9 of 23 have an industry lead sponsor. The 10 most frequent:
San Filippo Neri General Hospital is the lead sponsor of 10 studies on the registry; none are open to participants now.
San Filippo Neri General Hospital has 3 studies filed under Angina, Stable — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 23 studies in Angina, Stable with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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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Exclusion Criteria:
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
Sachets with inactive substance indistinguishable from Ecoviesel
Other: Placebo
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
Sachets of maltose, flavors and sylicium dioxide, indistinguishable from ecoviesel sachets.
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
Time frame: within 24 hours from coronary angioplasty
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
Time frame: within 24 hours from coronary angioplasty
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
Time frame: 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
Time frame: up to 30 days
changes in hs-CRP in all patients after treatment phases
Change in plasma hs-CRP concentration at any visit
Time frame: within 30 days of the invasive procedure
urine metabolomics in all patients after treatment phases
Change in urine metabolomics at any visit
Time frame: up to 30 days of the invasive procedure
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Sep 2016, a primary completion of Sep 2019 and a completion of Jan 2020. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Probiotic
San Filippo Neri General Hospital