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

NCT ID: NCT04605627

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-08

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Intestinal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic coronary syndrome

50 patients with chronic coronary disease

No interventions assigned to this group

Non ST segment-elevation myocardial infarction

75 patients with non ST-elevation myocardial infarction

No interventions assigned to this group

ST-elevation myocardial infarction

75 patients with ST segment-elevation myocardial infarction

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Research Council of Norway

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Geir Øystein Andersen

MD, PhD, Senior Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marius Trøseid, Md Ass.prof

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Department of Cardiology, Oslo University Hospital Ullevål

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Geir Ø Andersen, MD.PhD

Role: CONTACT

+4791502770

Facility Contacts

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Geir Ø Andersen, Md PhD

Role: primary

004791502770

Aasmund Norheim

Role: backup

004795525854

Other Identifiers

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Oslo University Hospital

Identifier Type: -

Identifier Source: org_study_id