Effect of Acute Cardiovascular Disease on Microbiome

NCT05456802 | Completed

• 1 other identifier: MIAMI Trial
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  Sampling will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.

Other Outcomes (5)

• Change of left ventricular global longitudinal strain (GLS) after presentation with ACS/CCS/CLI

  Echocardiography will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.

• Change of inflammatory profile (CRP, PCT, Interleukin panel) after presentation with ACS/CCS/CLI

  Sampling will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.

• Change of blood pressure after presentation with ACS/CCS/CLI

  Blood pressure measurements will be performed within 24 hours of presentation to the clinic and at day 28 (+/- 2 days) after initial presentation.

Study Arms (3)

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.

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.

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.

Other: Standard of care treatment

Interventions

Standard of care treatment OTHER

Standard of care treatment including percutaneous interventions was performed in all participants.

Acute Coronary Syndrome (ACS); Chronic Coronary Syndrome (CCS); Critical limb ischemia (CLI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \>18 years
• patient consent
• CCS, ACS or CLI
• angiographical confirmed peripheral or coronary artery disease

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

University of Essen, Clinic of Cardiology and Angiology

Essen, North Rhine-Westphalia, 45147, Germany

Location

Related Publications (1)

• 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.

  PMID: 40804540 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

stool and blood samples

MeSH Terms

Conditions

Communicable Diseases; Coronary Artery Disease; Myocardial Infarction; Acute Coronary Syndrome; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis; Atherosclerosis; Peripheral Vascular Diseases; Chronic Disease

Study Officials

• Christos Rammos, Prof. Dr.

  University Clinic Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. med.

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 13, 2022
• Study Start: August 12, 2022
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: September 24, 2024

Record last verified: 2024-09

Locations

DE (1)