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

Coronary Artery Disease Clinical Trial

— GUT-ACS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04605627
• Other study ID #: Oslo University Hospital
• Status: Recruiting
• Start date: October 8, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2020
• Source: Oslo University Hospital
• Contact: Geir Ø Andersen, MD.PhD
• Phone: +4791502770
• Email: g.o.andersen[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Intestinal Disease
• Intestinal Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
Norway	Department of Cardiology, Oslo University Hospital Ullevål	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

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