Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2022-08-12
2024-04-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Standard of care treatment
Standard of care treatment including percutaneous interventions was performed in all participants.
Chronic Coronary Syndrome (CCS)
Patients presenting to the clinic with chronic coronary syndrome and confirmed diagnosis of coronary artery disease.
Standard of care treatment
Standard of care treatment including percutaneous interventions was performed in all participants.
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.
Standard of care treatment
Standard of care treatment including percutaneous interventions was performed in all participants.
Interventions
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Standard of care treatment
Standard of care treatment including percutaneous interventions was performed in all participants.
Eligibility Criteria
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Inclusion Criteria
* patient consent
* CCS, ACS or CLI
* angiographical confirmed peripheral or coronary artery disease
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Essen
OTHER
Responsible Party
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Chistos Rammos
Professor Dr. med.
Principal Investigators
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Christos Rammos, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Clinic Essen
Locations
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University of Essen, Clinic of Cardiology and Angiology
Essen, North Rhine-Westphalia, Germany
Countries
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References
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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.
Other Identifiers
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MIAMI Trial
Identifier Type: -
Identifier Source: org_study_id
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