The Role of Gut Leakage Markers and Microbiota Signature in Coronary Artery Disease. (GUT-ACS)

October 21, 2020 updated by: Geir Øystein Andersen, Oslo University Hospital
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).

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Norway
      • Oslo, Norway, N-0852
        • Recruiting
        • Department of Cardiology, Oslo University Hospital Ullevål
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Geir Ø Andersen, MD PhD
        • Principal Investigator:
          • Marius Troseid, MD Ass.Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 20-75 years with coronary artery disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Chronic coronary syndrome
50 patients with chronic coronary disease
Non ST segment-elevation myocardial infarction
75 patients with non ST-elevation myocardial infarction
ST-elevation myocardial infarction
75 patients with ST segment-elevation myocardial infarction

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

The Research Council of Norway

Investigators

  • Principal Investigator: Marius Trøseid, Md Ass.prof, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

September 30, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (Actual)

October 28, 2020

Study Record Updates

Last Update Posted (Actual)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oslo University Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Study protocol, informed consent form (in Norwegian) and clinical study report will be shared by request.

IPD Sharing Time Frame

Data become available 01.06.2022, and will be available until 01.06.2023.

IPD Sharing Access Criteria

Requests by email will be answered.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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