Effect of Acute Cardiovascular Disease on Microbiome

Recruiting

• Conditions: Microbial Colonization; Peripheral Arterial Disease; Coronary Artery Disease; Critical Limb Ischemia; Myocardial Infarction; Acute Coronary Syndrome
• Interventions: Other: Standard of care treatment

• Registration Number: NCT05456802
• Lead Sponsor: University Hospital, Essen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-30
• Study First Submitted QC: 2022-07-09
• Study First Posted: 2022-07-13
• Study Start: 2022-08-12
• Status Verified: 2023-12
• Primary Completion: 2023-12-01
• Last Update Submitted: 2023-12-02
• Last Update Posted: 2023-12-05
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute Coronary Syndrome (ACS)	Standard of care treatment	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.
Chronic Coronary Syndrome (CCS)	Standard of care treatment	Patients presenting to the clinic with chronic coronary syndrome and confirmed diagnosis of coronary artery disease.
Critical limb ischemia (CLI)	Standard of care treatment	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.

Primary Outcome Measures

Name	Time	Method
Change of enteral microbiome composition after presentation with ACS/CCS/CLI	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	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.

Secondary Outcome Measures

Name	Time	Method
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.	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).
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.	Blood samples are collected at the below mentioned time points. SCFA serum levels will be measured by high-performance liquid chromatography (HPLC).

Trial Locations

Locations (1)

University of Essen, Clinic of Cardiology and Angiology; 🇩🇪 Essen, NRW, Germany