Chronic Stable AnginaMYDA-MINCT02908776
MYocardial DAmage AND MIcrobiota STUDY
A study testing Probiotic in people with Chronic Stable Angina and Periprocedural Myocardial Damage, run by San Filippo Neri General Hospital at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Stable Angina, Periprocedural Myocardial Damage
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2016to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic stable angina scheduled for coronary angiography and possible ad hoc percutaneous coronary intervention
Who cannot join
- Age >75 y.o
- Diabetes requiring treatment
- Abnormal c-TnI level before angiography
- Immunodeficiency status
- Need for oral vitamin K antagonists
- Need for antibiotics
Show all 9Show fewer
- Use of antibiotics or probiotics within 4 weeks of enrollment
- Cancer and diseases affecting 1 year prognosis
- Participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Filippo Neri General Hospital
Roma, RM, 00152
Christian Pristipino, MD, 00390633061, pristipino.c@gmail.com
About this study
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
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.
- Being tested
- Probiotic, Placebo
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called Ecoviesel
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.
PlaceboOther
Sachets of maltose, flavors and sylicium dioxide, indistinguishable from ecoviesel sachets.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Sachets with inactive substance indistinguishable from Ecoviesel Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 24 hours from coronary angioplasty
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: up to 30 days
changes in hs-CRP in all patients after treatment phases
Change in plasma hs-CRP concentration at any visit
Measured: within 30 days of the invasive procedure
urine metabolomics in all patients after treatment phases
Change in urine metabolomics at any visit
Measured: up to 30 days of the invasive procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Filippo Neri General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MENDES S.A., Lugano, Switzerland, Università degli studi di Bologna, Italy
- Responsible party
- Principal investigator, Christian Pristipino, San Filippo Neri General Hospital
- Investigators
- Christian Pristipino, MD, Principal investigator, San Filippo Neri General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908776
- Sponsor's protocol ID
- v216/6/2014
- Acronym
- MYDA-MI
- Status last verified
- Apr 2019
- First submitted
- 9 Feb 2016
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02908776
- Acronym / sponsor ID
- MYDA-MI / v216/6/2014
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- San Filippo Neri General HospitalUniversity, hospital or other
- Collaborators
- MENDES S.A., Lugano, Switzerland, Università degli studi di Bologna, Italy
- Study start
- Sep 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement - Probiotics | Experimental | Dietary Supplement: Probiotic4 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 | Other: PlaceboSachets with inactive substance indistinguishable from Ecoviesel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic stable angina scheduled for coronary angiography and possible ad hoc percutaneous coronary intervention
Key exclusion criteria (9 listed)
- Age >75 y.o
- Diabetes requiring treatment
- Abnormal c-TnI level before angiography
- Immunodeficiency status
- Need for oral vitamin K antagonists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticAlso: EcovieselSachets 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. | Dietary supplement | Dietary supplement - Probiotics |
| PlaceboSachets of maltose, flavors and sylicium dioxide, indistinguishable from ecoviesel sachets. | Other | Placebo |
Primary outcome
Incidence of abnormal c-TnI levels in patients undergoing coronary intervention
Time frame: within 24 hours from coronary angioplasty
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
5 secondary outcomes
peak of c-TnI levels in patients undergoing coronary intervention
Time frame: within 24 hours from coronary angioplasty
incidence of contrast-induced renal dysfunction in all patients
Time frame: within 24 hours from coronary angioplasty
in-hospital incidence of major adverse cardiac events in patients undergoing coronary intervention
Time frame: up to 30 days
changes in hs-CRP in all patients after treatment phases
Time frame: within 30 days of the invasive procedure
urine metabolomics in all patients after treatment phases
Time frame: up to 30 days of the invasive procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Pristipino, MD principal investigator
San Filippo Neri General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Chronic Stable Angina and Periprocedural Myocardial Damage, run by San Filippo Neri General Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Pristipino, MD (+39060633062504, pristipino.c@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of abnormal c-TnI levels in patients undergoing coronary intervention (time frame: within 24 hours from coronary angioplasty). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019; AzTrials last refreshed its copy on 27 Oct 2026.