Coronary Artery DiseaseGUT-ACSNCT04605627
The Role of Gut Leakage Markers and Microbiota Signature in Coronary Artery Disease.
An observational study of Coronary Artery Disease and Intestinal Disease, run by Oslo University Hospital at 1 site in Norway.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Intestinal Disease
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 8 Oct 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 20-75 years with coronary artery disease.
Who may be able to join
- Coronary heart disease verified by coronary angiography
Who cannot join
- Current infection requiring intravenous antibiotics
- Inflammatory bowel disease
- Renal failure with creatinine > 200µmol/L
- Hepatic impairment
- Pregnancy
- Previous bariatric surgery
- Colostomy
- Active malignant disease
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Department of Cardiology, Oslo University Hospital Ullevål
Oslo, N-0852
Geir Ø Andersen, Md PhD, 004791502770, g.o.andersen@medisin.uio.no
Aasmund Norheim, 004795525854, aasmund.norheim@gmail.com
About this study
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).
Read the 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.
- Conditions
- Coronary Artery Disease, Intestinal Disease
- Keywords
- Gut leakage, Microbiota, Coronary artery disease, STEMI, NSTEMI, Chronic coronary syndrome
- Medical subject headings
- Coronary Artery Disease, Intestinal Diseases, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Microbiota alpha diversity in myocardial infarction measured as Chao1 Index.
fecal-sample. 16srRNA (Miseq) will be used for sequencing.
Measured: Within 7 days from inclusion.
Microbiota alpha diversity in myocardial infarction measured as Chao1 Index
fecal-sample. 16srRNA (Miseq) will be used for sequencing.
Measured: At 3 months follow-up.
Lipopolysaccharide binding protein (LBP) in myocardial infarction
Blood sample. Analyses will be performed with ELISA.
Measured: At inclusion
Lipopolysaccharide binding protein (LBP) in myocardial infarction
Blood sample. Analyses will be performed with ELISA.
Measured: Change from inclusion to 3 months follow-up.
Soluble cluster of difference-14 in myocardial infarction
Blood sample. Analyses will be performed with ELISA.
Measured: At inclusion
Soluble cluster of difference-14 in myocardial infarction
Blood sample. Analyses will be performed with ELISA.
Measured: Change from inclusion to 3 months follow-up.
Intestinal fatty acid binding protein-1 in myocardial infarction
Blood sample. Analyses will be performed with ELISA.
Measured: At inclusion
Intestinal fatty acid binding protein-1 in myocardial infarction
Blood sample. Analyses will be performed with ELISA.
Measured: Change from inclusion to 3 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start8 Oct 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Principal investigator, Geir Øystein Andersen, Oslo University Hospital
- Investigators
- Marius Trøseid, Md Ass.prof, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605627
- Sponsor's protocol ID
- Oslo University Hospital
- Acronym
- GUT-ACS
- Status last verified
- Oct 2020
- First submitted
- 30 Sep 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, informed consent form (in Norwegian) and clinical study report will be shared by request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Gut Leakage Markers and Microbiota Signature in Coronary Artery Disease.
- ClinicalTrials.gov ID
- NCT04605627
- Acronym / sponsor ID
- GUT-ACS / Oslo University Hospital
- Conditions
- Coronary Artery Disease, Intestinal Disease
- Keywords
- Gut leakage, Microbiota, Coronary artery disease, STEMI, NSTEMI, Chronic coronary syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 20-75 years with coronary artery disease.
Key inclusion criteria (1 listed)
- Coronary heart disease verified by coronary angiography
Key exclusion criteria (8 listed)
- Current infection requiring intravenous antibiotics
- Inflammatory bowel disease
- Renal failure with creatinine > 200µmol/L
- Hepatic impairment
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Lipopolysaccharide binding protein (LBP) in myocardial infarction
Time frame: At inclusion
Blood sample. Analyses will be performed with ELISA.
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.
Soluble cluster of difference-14 in myocardial infarction
Time frame: At inclusion
Blood sample. Analyses will be performed with ELISA.
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.
Intestinal fatty acid binding protein-1 in myocardial infarction
Time frame: At inclusion
Blood sample. Analyses will be performed with ELISA.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Individual participant dataSharing planned: Yes. Study protocol, informed consent form (in Norwegian) and clinical study report will be shared by request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marius Trøseid, Md Ass.prof principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Intestinal Disease, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geir Ø Andersen, MD.PhD (+4791502770, g.o.andersen@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota alpha diversity in myocardial infarction measured as Chao1 Index. (time frame: Within 7 days from inclusion.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.