Adipose Tissue and Inflammation in Coronary Heart Disease

NCT ID: NCT02760914

Last Updated: 2021-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2029-12-31

Brief Summary

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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

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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

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Coronary Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Coronary heart disease

Patients with coronary heart disease undergoing planned coronary artery bypass surgery

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with coronary heart disease undergoing coronary artery bypass surgery

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Svein Solheim

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ingebjørg Seljeflot, Professor

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital, Ullevål, Oslo, Norway

Locations

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Svein Solheim

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 37730614 (View on PubMed)

Other Identifiers

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2016/441

Identifier Type: -

Identifier Source: org_study_id

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