NCT02760914

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
42mo left

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jun 2016Dec 2029

First Submitted

Initial submission to the registry

May 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
28 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
13.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

13.5 years

First QC Date

May 2, 2016

Last Update Submit

February 23, 2021

Conditions

Keywords

adipose tissueinflammatory mediatorsgene expression

Outcome Measures

Primary Outcomes (1)

  • 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.

    At inclusion

Study Arms (1)

Coronary heart disease

Patients with coronary heart disease undergoing planned coronary artery bypass surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients with coronary heart disease undergoing coronary artery bypass surgery

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Svein Solheim

Oslo, 0407, Norway

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

adipose tissue, whole blood

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Ingebjørg Seljeflot, Professor

    Oslo University Hospital, Ullevål, Oslo, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 4, 2016

Study Start

June 1, 2016

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

February 26, 2021

Record last verified: 2021-02

Locations