Microbial ColonizationMIAMINCT05456802
Effect of Acute Cardiovascular Disease on Microbiome
An observational study of Microbial Colonization and Coronary Artery Disease, run by University Hospital, Essen at 1 site in Germany.
Trial summary
Atherosclerotic diseases such as coronary artery disease (CAD) and peripheral arterial disease (PAD) are the leading cause of morbidity and mortality in the industrialized world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microbial Colonization, Coronary Artery Disease, Myocardial Infarction
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 12 Aug 2022to 1 Apr 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 18 years presenting to the clinic with acute coronary syndrome (ACS), chronic coronary syndrome (CCS) or critical limb threatening ischemia (CLI) who can be included into the study within a 24 hours time frame after presentation.
Who may be able to join
- >18 years
- patient consent
- CCS, ACS or CLI
- angiographical confirmed peripheral or coronary artery disease
Who cannot join
- pregnancy/lactation period
- current antibiotic treatment or in the past 3 months
- chronic inflammatory bowel disease
- short bowel syndrome
- artificial bowel outlet
- persistent diarrhea or vomiting in the past 3 months
- simultaneous participation in another interfering nutrition study
- active chemo or radiation therapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Essen, Clinic of Cardiology and Angiology
Essen, North Rhine-Westphalia, 45147
About this study
Official title: The Influence of a Symptomatic Coronary Artery and Peripheral Arterial Disease on the Oral-enteral Microbiome and Downstream Microbiome-dependent Metabolites
Atherosclerotic diseases such as coronary artery disease (CAD) and peripheral arterial disease (PAD) are the leading cause of morbidity and mortality in the industrialized world.
An interaction between the development of atherosclerotic diseases and the oral and enteral microbiome composition has already been demonstrated in the past. The microbiome is a double-edged sword which can convey protective and detrimental cardiovascular effects. While it can promote the development of atherosclerosis through the production of atherogenic metabolites such as trimethylamine N-oxide (TMAO) it can also generate a protective effect through the production of metabolites such as short chain fatty acids (SCFA). Preliminary data suggest that atherosclerotic disease itself can induce a dysbiosis of the microbiome.
Aim of this study is to determine the differences in coronary artery disease and peripheral arterial disease on the oral-enteral microbiome axis and downstream microbiome-dependent metabolites.
- Conditions
- Microbial Colonization, Coronary Artery Disease, Myocardial Infarction, Acute Coronary Syndrome, Peripheral Arterial Disease, Critical Limb Ischemia
- Being tested
- Standard of care treatment
- Medical subject headings
- Communicable Diseases, Coronary Artery Disease, Myocardial Infarction, Acute Coronary Syndrome, Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care treatmentOther
Standard of care treatment including percutaneous interventions was performed in all participants.
| Study group | Role | What they receive |
|---|---|---|
| Acute Coronary Syndrome (ACS) | Patients presenting to the clinic with acute coronary syndrome. This includes: ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI) and unstable angina pectoris (UAP) with confirmed diagnosis of coronary artery disease. Receives: Other: Standard of care treatment | |
| Chronic Coronary Syndrome (CCS) | Patients presenting to the clinic with chronic coronary syndrome and confirmed diagnosis of coronary artery disease. Receives: Other: Standard of care treatment | |
| Critical limb ischemia (CLI) | Patients presenting to the clinic with critical limb ischemia. This includes: Resting limb pain (Fontaine III), ulcerations (Fontaine IV) and Ankle brachial index (ABI) < 0,6 and confirmed diagnosis of peripheral artery disease. Receives: Other: Standard of care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of enteral microbiome composition after presentation with ACS/CCS/CLI
Stool samples are collected at the below mentioned time points. DNA isolation will be performed with consecutive 16S-RNA analysis and cluster analysis.
Measured: Sampling will be performed within 24 hours of presentation to the clinic, at day 3, day 7, day 14 and at day 28 (+/- 2 days) after initial presentation.
Change of oral microbiome composition after presentation with ACS/CCS/CLI
Oral samples are collected at the below mentioned time points. DNA isolation will be performed with consecutive 16S-RNA analysis and cluster analysis.
Measured: Sampling will be performed within 24 hours of presentation to the clinic, at day 3, day 7, day 14 and at day 28 (+/- 2 days) after initial presentation.
Secondary outcomes (2)
Change of TMAO serum levels after presentation with ACS/CCS/CLI
Blood samples are collected at the below mentioned time points. TMAO serum levels will be measured by ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS).
Measured: Sampling will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.
Change of SCFA serum levels after presentation with ACS/CCS/CLI
Blood samples are collected at the below mentioned time points. SCFA serum levels will be measured by high-performance liquid chromatography (HPLC).
Measured: Sampling will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start12 Aug 2022
- Primary completion1 Feb 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chistos Rammos, University Hospital, Essen
- Investigators
- Christos Rammos, Prof. Dr., Principal investigator, University Clinic Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456802
- Sponsor's protocol ID
- MIAMI Trial
- Acronym
- MIAMI
- Status last verified
- Sep 2024
- First submitted
- 30 Jun 2022
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Messiha D, Lange E, Tratnik A, M Westendorf A, Rinke M, Lenz S, Hendgen-Cotta UB, Buer J, Rassaf T, Rammos C. The influence of acute and chronic coronary syndrome on the gut microbiome and downstream microbiome-derived metabolites-Microbiome in acute myocardial infarction-MIAMI-Trial. Basic Res Cardiol. 2025 Oct;120(5):913-924. doi: 10.1007/s00395-025-01134-9. Epub 2025 Aug 13.
PubMed 40804540
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of a Symptomatic Coronary Artery and Peripheral Arterial Disease on the Oral-enteral Microbiome and Downstream Microbiome-dependent Metabolites
- ClinicalTrials.gov ID
- NCT05456802
- Acronym / sponsor ID
- MIAMI / MIAMI Trial
- Conditions
- Microbial Colonization, Coronary Artery Disease, Myocardial Infarction, Acute Coronary Syndrome, Peripheral Arterial Disease, Critical Limb Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 13 Jul 2022 (actual)
- 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.
Atherosclerotic diseases such as coronary artery disease (CAD) and peripheral arterial disease (PAD) are the leading cause of morbidity and mortality in the industrialized world.
An interaction between the development of atherosclerotic diseases and the oral and enteral microbiome composition has already been demonstrated in the past. The microbiome is a double-edged sword which can convey protective and detrimental cardiovascular effects. While it can promote the development of atherosclerosis through the production of atherogenic metabolites such as trimethylamine N-oxide (TMAO) it can also generate a protective effect through the production of metabolites such as short chain fatty acids (SCFA). Preliminary data suggest that atherosclerotic disease itself can induce a dysbiosis of the microbiome.
Aim of this study is to determine the differences in coronary artery disease and peripheral arterial disease on the oral-enteral microbiome axis and downstream microbiome-dependent metabolites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute Coronary Syndrome (ACS) | – | Other: Standard of care treatmentPatients presenting to the clinic with acute coronary syndrome. This includes: ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI) and unstable angina pectoris (UAP) with confirmed diagnosis of coronary artery disease. |
| Chronic Coronary Syndrome (CCS) | – | Other: Standard of care treatmentPatients presenting to the clinic with chronic coronary syndrome and confirmed diagnosis of coronary artery disease. |
| Critical limb ischemia (CLI) | – | Other: Standard of care treatmentPatients presenting to the clinic with critical limb ischemia. This includes: Resting limb pain (Fontaine III), ulcerations (Fontaine IV) and Ankle brachial index (ABI) < 0,6 and confirmed diagnosis of peripheral artery disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years presenting to the clinic with acute coronary syndrome (ACS), chronic coronary syndrome (CCS) or critical limb threatening ischemia (CLI) who can be included into the study within a 24 hours time frame after presentation.
Key inclusion criteria (4 listed)
- >18 years
- patient consent
- CCS, ACS or CLI
- angiographical confirmed peripheral or coronary artery disease
Key exclusion criteria (8 listed)
- pregnancy/lactation period
- current antibiotic treatment or in the past 3 months
- chronic inflammatory bowel disease
- short bowel syndrome
- artificial bowel outlet
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 |
|---|---|---|
| Standard of care treatmentStandard of care treatment including percutaneous interventions was performed in all participants. | Other | Acute Coronary Syndrome (ACS), Chronic Coronary Syndrome (CCS), Critical limb ischemia (CLI) |
Primary outcome
Change of enteral microbiome composition after presentation with ACS/CCS/CLI
Time frame: Sampling will be performed within 24 hours of presentation to the clinic, at day 3, day 7, day 14 and at day 28 (+/- 2 days) after initial presentation.
Stool samples are collected at the below mentioned time points. DNA isolation will be performed with consecutive 16S-RNA analysis and cluster analysis.
Change of oral microbiome composition after presentation with ACS/CCS/CLI
Time frame: Sampling will be performed within 24 hours of presentation to the clinic, at day 3, day 7, day 14 and at day 28 (+/- 2 days) after initial presentation.
Oral samples are collected at the below mentioned time points. DNA isolation will be performed with consecutive 16S-RNA analysis and cluster analysis.
2 secondary outcomes
Change of TMAO serum levels after presentation with ACS/CCS/CLI
Time frame: Sampling will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.
Change of SCFA serum levels after presentation with ACS/CCS/CLI
Time frame: Sampling will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Derived from this study: PubMed 40804540Messiha D, Lange E, Tratnik A, M Westendorf A, Rinke M, Lenz S, Hendgen-Cotta UB, Buer J, Rassaf T, Rammos C. The influence of acute and chronic coronary syndrome on the gut microbiome and downstream microbiome-derived metabolites-Microbiome in acute myocardial infarction-MIAMI-Trial. Basic Res Cardiol. 2025 Oct;120(5):913-924. doi: 10.1007/s00395-025-01134-9. Epub 2025 Aug 13.
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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.
Christos Rammos, Prof. Dr. principal investigator
University Clinic Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbial Colonization and Coronary Artery Disease, run by University Hospital, Essen at 1 site in Germany.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 24 Sep 2024. 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 Germany. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of enteral microbiome composition after presentation with ACS/CCS/CLI (time frame: Sampling will be performed within 24 hours of presentation to the clinic, at day 3, day 7, day 14 and at day 28 (+/- 2 days) after initial presentation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05456802, which also lists 1 linked publication.
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 24 Sep 2024.