The Role of Gut Leakage Markers and Microbiota Signature in Coronary Artery Disease.

• Conditions: Coronary Artery Disease; Intestinal Disease

• Registration Number: NCT04605627
• Lead Sponsor: Oslo University Hospital

Brief Summary

Define a signature of gut microbiota composition and related metabolites in patients with ST-elevation myocardial infarction, non ST-elevation myocardial infarction and chronic coronary disease (CAD).

Detailed Description

A total of 200 patients, allocated to 50 patients with chronic coronary syndrome, 75 patients with non-ST elevation myocardial infarction and 75 patients with ST- elevation myocardial infarction will be included. Clinical information, blood samples and fecal samples will be collected. Fecal and blood samples will be collected once in patients With chronic disease and in patients with acute coronary syndrome; in the acute phase and after 3 months.

Study Timeline

• Study First Submitted: 2020-09-30
• Status Verified: 2020-10
• Study Start: 2020-10-08
• Study First Submitted QC: 2020-10-21
• Last Update Submitted: 2020-10-21
• Study First Posted: 2020-10-28
• Last Update Posted: 2020-10-28
• Primary Completion: 2021-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Coronary heart disease verified by coronary angiography

Exclusion Criteria

• Current infection requiring intravenous antibiotics
• Inflammatory bowel disease
• Renal failure with creatinine > 200µmol/L
• Hepatic impairment
• Pregnancy
• Previous bariatric surgery
• Colostomy
• Active malignant disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lipopolysaccharide binding protein (LBP) in myocardial infarction	Change from inclusion to 3 months follow-up.	Blood sample. Analyses will be performed with ELISA.
Microbiota alpha diversity in myocardial infarction measured as Chao1 Index	At 3 months follow-up.	fecal-sample. 16srRNA (Miseq) will be used for sequencing.
Microbiota alpha diversity in myocardial infarction measured as Chao1 Index.	Within 7 days from inclusion.	fecal-sample. 16srRNA (Miseq) will be used for sequencing.
Soluble cluster of difference-14 in myocardial infarction	Change from inclusion to 3 months follow-up.	Blood sample. Analyses will be performed with ELISA.
Intestinal fatty acid binding protein-1 in myocardial infarction	Change from inclusion to 3 months follow-up.	Blood sample. Analyses will be performed with ELISA.

Trial Locations

Locations (1)

Department of Cardiology, Oslo University Hospital Ullevål; 🇳🇴 Oslo, Norway