NCT02908009

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 19, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 9, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2024

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

8.1 years

First QC Date

July 19, 2016

Last Update Submit

November 9, 2023

Conditions

C.Surgical Procedure; Cardiac

Outcome Measures

Primary Outcomes (1)

  • Post surgery inotrope score

    inotrope score measured up to 48 hours post-surgery

    inotrope score measured up to 48 hours post-surgery

Secondary Outcomes (11)

  • Changes in expression of target genes

    Collected at the time of surgery

  • Changes in epigenetic regulation of target genes from left atrial biopsies.

    Collected at the time of surgery

  • Changes in mitochondrial function

    before and after sugery (up to 12 hours post surgery)

  • Myocardial Injury

    baseline and 24 hours

  • Acute kidney injury

    baseline, and up to 15 days post surgery (discharge)

  • +6 more secondary outcomes

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study will be carried out at a large tertiary academic cardiac surgery unit in the UK; the University Hospitals of Leicester NHS Trust. This unit performs over 1,200 major cardiac procedures per year, of which 600 are patients undergoing coronary artery bypass grafting

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

England

Glenfield, Leicestershire, LE3 9QP, United Kingdom

RECRUITING

Related Publications (3)

  • 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.

    PMID: 22797452BACKGROUND

  • 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.

    PMID: 7587228BACKGROUND

  • 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.

    PMID: 35082386DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Atrial Biopsy: A 0.5cm x 0.5cm section of the right atrial wall is routinely excised to allow cannulation of the left atrium for connection to the cardiopulmonary bypass machine. This segment is routinely discarded. We propose to collect this specimen immediately after it has been discarded.

Study Officials

  • Gavin Murphy

    University of Leicester

    PRINCIPAL INVESTIGATOR

  • Filiberto Serraino

    University of Leicester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tracy Kumar

CONTACT

01162583039tk98@leicester.ac.uk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2016

First Posted

September 20, 2016

Study Start

September 9, 2016

Primary Completion

October 7, 2024

Study Completion

October 7, 2024

Last Updated

November 14, 2023

Record last verified: 2023-11

Locations

GB(1)