Adipose Tissue and Inflammation in Coronary Heart Disease (ATICH)

February 23, 2021 updated by: Svein Solheim, Oslo University Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

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

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Svein Solheim

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with coronary heart disease undergoing planned coronary artery bypass surgery.

Description

Inclusion Criteria:

  • Patients with coronary heart disease undergoing coronary artery bypass surgery

Exclusion Criteria:

  • None

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

Cohorts and Interventions

Group / Cohort
Coronary heart disease
Patients with coronary heart disease undergoing planned coronary artery bypass surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At inclusion

Collaborators and Investigators

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

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Ingebjørg Seljeflot, Professor, Oslo University Hospital, Ullevål, Oslo, Norway

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)

June 1, 2016

Primary Completion (Anticipated)

December 1, 2029

Study Completion (Anticipated)

December 1, 2029

Study Registration Dates

First Submitted

May 2, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Actual)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/441

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.

Clinical Trials on Coronary Heart Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe