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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04605627

Acronym

GUT-ACS

Enrollment

200

Registered

2020-10-28

Start date

2020-10-08

Completion date

2023-12-31

Last updated

2020-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Intestinal Disease

Keywords

Gut leakage, Microbiota, Coronary artery disease, STEMI, NSTEMI, Chronic coronary syndrome

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Norway

Contacts

Primary ContactGeir Ø Andersen, MD.PhD

g.o.andersen@medisin.uio.no+4791502770

Outcome results