A Case Control Study to Identify the Role of Epigenetic Regulation of Genes Responsible for Energy Metabolism and Mitochondrial Function in the Obesity Paradox in Cardiac Surgery

NCT ID: NCT02908009

Last Updated: 2023-11-14

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

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-09

Study Completion Date

2024-10-07

Brief Summary

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This is a prospective, single-centre case control comparison of expression of target genes responsible for energy utilisation, mitochondrial function and oxidative stress and levels of histone acetylation/ DNA methylation in obese and non-obese adult cardiac surgery patients. The study aims to test several inter-related hypotheses in a consecutive sequence of patients undergoing coronary artery bypass grafting.

Detailed Description

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Conditions

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C.Surgical Procedure; Cardiac

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with pre-existing paroxysmal, persistent or chronic atrial fibrillation,

Exclusion Criteria

* Patients with pre-existing inflammatory state: sepsis undergoing treatment, acute kidney injury within 5 days, chronic inflammatory disease, congestive heart failure.
* Emergency or salvage procedure.
* Ejection fraction \<30 %.
* Patient in a critical preoperative state (Kidney Disease: Improving Global Outcomes (KDIGO) Stage 3 AKI \[20\] or requiring inotropes, ventilation or intra-aortic balloon pump).
* Pregnancy.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leicester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gavin Murphy

Role: PRINCIPAL_INVESTIGATOR

University of Leicester

Filiberto Serraino

Role: PRINCIPAL_INVESTIGATOR

University of Leicester

Locations

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England

Glenfield, Leicestershire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Tracy Kumar

Role: CONTACT

01162583039

References

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ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

Reference Type BACKGROUND
PMID: 22797452 (View on PubMed)

Marshall JC, Cook DJ, Christou NV, Bernard GR, Sprung CL, Sibbald WJ. Multiple organ dysfunction score: a reliable descriptor of a complex clinical outcome. Crit Care Med. 1995 Oct;23(10):1638-52. doi: 10.1097/00003246-199510000-00007.

Reference Type BACKGROUND
PMID: 7587228 (View on PubMed)

Adebayo AS, Roman M, Zakkar M, Yusoff S, Gulston M, Joel-David L, Anthony B, Lai FY, Murgia A, Eagle-Hemming B, Sheikh S, Kumar T, Aujla H, Dott W, Griffin JL, Murphy GJ, Wozniak MJ. Gene and metabolite expression dependence on body mass index in human myocardium. Sci Rep. 2022 Jan 26;12(1):1425. doi: 10.1038/s41598-022-05562-8.

Reference Type DERIVED
PMID: 35082386 (View on PubMed)

Other Identifiers

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0574

Identifier Type: -

Identifier Source: org_study_id

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