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Clinical Trials/NCT02760914
NCT02760914
Active, not recruiting
Not Applicable

Inflammatory Activity in Various Compartments of Adipose Tissue in Patients With Coronary Heart Disease

Oslo University Hospital1 site in 1 country50 target enrollmentJune 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Heart Disease
Sponsor
Oslo University Hospital
Enrollment
50
Locations
1
Primary Endpoint
Inflammasome-related proteins
Status
Active, not recruiting
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
December 2029
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Svein Solheim

MD, PhD

Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with coronary heart disease undergoing coronary artery bypass surgery

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Study Sites (1)

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