Coronary Heart DiseaseATICHNCT02760914
Adipose Tissue and Inflammation in Coronary Heart Disease
An observational study of Coronary Heart Disease, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The aims of the present project are to study possible differences in inflammatory gene expression and protein secretion in various compartments of adipose tissue being exposed during open cardiac surgery in patients with coronary heart disease undergoing coronary artery bypass surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2016to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with coronary heart disease undergoing planned coronary artery bypass surgery.
Who may be able to join
- Patients with coronary heart disease undergoing coronary artery bypass surgery
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inflammatory Activity in Various Compartments of Adipose Tissue in Patients With Coronary Heart Disease
The aims of the present project are to study possible differences in inflammatory gene expression and protein secretion in various compartments of adipose tissue being exposed during open cardiac surgery in patients with coronary heart disease undergoing coronary artery bypass surgery.
Read the detailed description
The present study is observational with biochemical end-points to disclose inflammatory mechanisms in various compartments of adipose tissue in patients with coronary heart disease (CHD) compared to patients without significant CHD. Fifty patients with CHD undergoing coronary artery bypass surgery with open chest procedure will be included and 20 patients with valve disease without overt CHD undergoing open valve surgery will serve as a control group. No specific restrictions to inclusion other than lack of consent to participate after written and oral information are listed. In patients undergoing open heart surgery for CHD, representative peri-operative biopsies from epicardial, pericardial and subcutaneous fat will be gathered, carefully processed and deep-frozen to 80 degrees of frost for later analyses on histological/cellular components and on messenger ribonucleic acid for selected inflammatory variables. Simultaneously, blood samples (arterial blood at start of operation) will be collected, processed and deep-frozen at 80 degrees of frost for later analyses of relevant circulating inflammatory variables to correlation analyses with tissue samples, possibly also PaxGene tubes for messenger ribonucleic acid in circulating leukocytes.
The study will be conducted according to the Declaration of Helsinki, and in accordance with approval from the Regional Ethics Committee.
- Conditions
- Coronary Heart Disease
- Keywords
- adipose tissue, inflammatory mediators, gene expression
- Medical subject headings
- Coronary Disease
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 |
|---|---|---|
| Coronary heart disease | Patients with coronary heart disease undergoing planned coronary artery bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammasome-related proteins
Inflammasome-related proteins (IL-18, IL-1b, NLRP3, Caspase, TLR4, IL-6, IL-6R, gp130), markers of remodeling (i.e. MMP-9, TIMP-1, PAI-1, Galectin, EMMPRIN), adipokines (i.e adiponectin, visfatin), other relevant pro-and anti-inflammatory cytokines (like TNF-alpha, IL-8, IL-12, IFN-gamma, MCP-1, IL-4, IL-10, TGF beta.) Relevant laboratory methods; qPCR (mRNA - all compartments + PAXGenetubes (leukocytes); Immunohistochemically; Circulating (where possible) (ELISAs and/or Multiplex). Results will be recorded in a database for further statistical analyses.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svein Solheim, Oslo University Hospital
- Investigators
- Ingebjørg Seljeflot, Professor, Principal investigator, Oslo University Hospital, Ullevål, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760914
- Sponsor's protocol ID
- 2016/441
- Acronym
- ATICH
- Status last verified
- Feb 2021
- First submitted
- 2 May 2016
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Opstad TB, Papotti B, Akra S, Hansen CH, Braathen B, Tonnessen T, Solheim S, Seljeflot I. Sirtuin1, not NAMPT, possesses anti-inflammatory effects in epicardial, pericardial and subcutaneous adipose tissue in patients with CHD. J Transl Med. 2023 Sep 21;21(1):644. doi: 10.1186/s12967-023-04518-4.
PubMed 37730614
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Activity in Various Compartments of Adipose Tissue in Patients With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT02760914
- Acronym / sponsor ID
- ATICH / 2016/441
- Conditions
- Coronary Heart Disease
- Keywords
- adipose tissue, inflammatory mediators, gene expression
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 4 May 2016 (estimated)
- 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.
The aims of the present project are to study possible differences in inflammatory gene expression and protein secretion in various compartments of adipose tissue being exposed during open cardiac surgery in patients with coronary heart disease undergoing coronary artery bypass surgery.
Detailed description
The present study is observational with biochemical end-points to disclose inflammatory mechanisms in various compartments of adipose tissue in patients with coronary heart disease (CHD) compared to patients without significant CHD. Fifty patients with CHD undergoing coronary artery bypass surgery with open chest procedure will be included and 20 patients with valve disease without overt CHD undergoing open valve surgery will serve as a control group. No specific restrictions to inclusion other than lack of consent to participate after written and oral information are listed. In patients undergoing open heart surgery for CHD, representative peri-operative biopsies from epicardial, pericardial and subcutaneous fat will be gathered, carefully processed and deep-frozen to 80 degrees of frost for later analyses on histological/cellular components and on messenger ribonucleic acid for selected inflammatory variables. Simultaneously, blood samples (arterial blood at start of operation) will be collected, processed and deep-frozen at 80 degrees of frost for later analyses of relevant circulating inflammatory variables to correlation analyses with tissue samples, possibly also PaxGene tubes for messenger ribonucleic acid in circulating leukocytes.
The study will be conducted according to the Declaration of Helsinki, and in accordance with approval from the Regional Ethics Committee.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary heart disease | – | –Patients with coronary heart disease undergoing planned coronary artery bypass surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary heart disease undergoing planned coronary artery bypass surgery.
Key inclusion criteria (1 listed)
- Patients with coronary heart disease undergoing coronary artery bypass surgery
Key exclusion criteria (1 listed)
- None
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
Inflammasome-related proteins
Time frame: At inclusion
Inflammasome-related proteins (IL-18, IL-1b, NLRP3, Caspase, TLR4, IL-6, IL-6R, gp130), markers of remodeling (i.e. MMP-9, TIMP-1, PAI-1, Galectin, EMMPRIN), adipokines (i.e adiponectin, visfatin), other relevant pro-and anti-inflammatory cytokines (like TNF-alpha, IL-8, IL-12, IFN-gamma, MCP-1, IL-4, IL-10, TGF beta.) Relevant laboratory methods; qPCR (mRNA - all compartments + PAXGenetubes (leukocytes); Immunohistochemically; Circulating (where possible) (ELISAs and/or Multiplex). Results will be recorded in a database for further statistical analyses.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Derived from this study: PubMed 37730614Opstad TB, Papotti B, Akra S, Hansen CH, Braathen B, Tonnessen T, Solheim S, Seljeflot I. Sirtuin1, not NAMPT, possesses anti-inflammatory effects in epicardial, pericardial and subcutaneous adipose tissue in patients with CHD. J Transl Med. 2023 Sep 21;21(1):644. doi: 10.1186/s12967-023-04518-4.
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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.
Ingebjørg Seljeflot, Professor principal investigator
Oslo University Hospital, Ullevål, Oslo, Norway
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 Heart 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 1 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: under way, not looking for participants, as of the sponsor's last update on 26 Feb 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammasome-related proteins (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02760914, which also lists 1 linked publication.
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 26 Feb 2021.