Adipose Tissue and Inflammation in Coronary Heart Disease

Active, not recruiting

• Conditions: Coronary Heart Disease

• Registration Number: NCT02760914
• Lead Sponsor: Oslo University Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-04
• Study Start: 2016-06
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-26
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with coronary heart disease undergoing coronary artery bypass surgery

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inflammasome-related proteins	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.

Trial Locations

Locations (1)

Svein Solheim; 🇳🇴 Oslo, Norway