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Organ DysfunctionEpi-SICCSNCT07865026

Epigenetic Susceptibility to Inflammatory Complications After Cardiac Surgery

An observational study of Organ Dysfunction and Inflammation in Cardiac Surgery, run by University of Glasgow at 1 site in United Kingdom.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to better understand 3 crucial questions: 1. Why do some patients experience more severe complications after heart surgery than others? 2. Are there markers on our genetic makeup (called epigenetic modifications) that can predict complications after major surgery? 3. Read more about this study

Who is it for?
Ages 18 years and older
How many people
30 participants
Where
1 siteUnited Kingdom
Study dates
Sep 2026to Mar 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Elective coronary artery bypass grafting (CABG) surgery with cardiopulmonary bypass at the Golden Jubilee National Hospital (NHS).

Who may be able to join

  • Provision of informed consent
  • Age >18 years
  • Planned elective coronary artery bypass grafting (CABG) surgery with cardiopulmonary bypass

Who cannot join

  • Pregnancy.
  • On-going participation in any investigational research which could undermine the scientific basis of the study.
  • Previous major surgery (as per PQIP procedures list) within three months prior to recruitment, or previous midline sternotomy.
  • Patients receiving immunosuppressive therapies for a chronic inflammatory condition or cancer.
  • Patients with a haematological malignancy.
  • Inadequate comprehension of English resulting in inability to comply with instructions.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ben Shelley, MBChB Dip(Paed) FRCA FFICM MD contact

0141 951 5000

Benjamin.Shelley@glasgow.ac.uk

United Kingdom1 site
  • Golden Jubilee National Hospital, NHS National Waiting Times Centre

    Glasgow, West Dunbartonshire, G81 4HX

Other trials in United Kingdom

About this study

Official title: Epigenetic Susceptibility to Inflammatory Complications After Cardiac Surgery (Epi-SICCS)

This study aims to better understand 3 crucial questions:

  1. Why do some patients experience more severe complications after heart surgery than others?
  2. Are there markers on our genetic makeup (called epigenetic modifications) that can predict complications after major surgery?
  3. How do epigenetic modifications lead to overactive inflammation that causes harm to patients after heart surgery?
Read more

Over 270,000 patients undergo major surgery in Scotland each year. Major surgery is associated with increased risk of complications, particularly in older patients with multiple health conditions. Complications are a leading cause of death, delayed recovery, long-term illness and increased healthcare cost to the NHS. Significant complications occur in up to 57% of patients after heart surgery. In response to major surgery, the body stimulates an inflammatory response as part of a complex repair mechanism, however, in some cases inflammation can become exaggerated, becoming harmful and contributing to the development of complications.

The investigators believe that a patient's risk of overactive inflammation, which can lead to complications after surgery, is heavily influenced by a patient-specific system of biological markers, layered upon their DNA; a scientific field known as epigenetics. Where a patient's DNA (their 'genetics') may be considered as an instruction manual for each cell's molecular processes, these 'epigenetic' markers work as if someone has highlighted sections of the manual to be read (and actioned). The pattern of these markers on immune system cells can therefore dictate the extent of the inflammatory response, especially after a major insult such as surgery. While the DNA itself cannot be modified, epigenetic markers can be modified, through strategies including diet, exercise, and medication.

The aim of this study is to evaluate whether the modifiable epigenetic code of key immune-system cells dictates the extent of post-operative inflammation, contributing to organ damage and complications.

With patients' permission, the investigators will:

  1. Obtain blood samples before and after major heart surgery, to test for epigenetic markers and inflammation.
  2. Observe patients after surgery and collect routine data from laboratory tests and patient observations which assess for organ dysfunction and inflammation.
  3. Conduct patient questionnaires before and after surgery to assess physical fitness and patient-centred quality of life measures.
  4. Analyse patterns between patients who have severe organ dysfunction after surgery and those patients who have minimal organ dysfunction after similar surgery, to better understand which patients are at greatest risk, according to their epigenetic makeup.

This study may improve understanding of which patients are likely to suffer organ damage and complications after major surgery, and which patients may have a protective epigenetic makeup which reduces complications. With this knowledge, the investigators aim is that future patients could receive personalised treatment plans before surgery, to modify their epigenetic makeup, reduce harm from complications and improve outcomes for patients. The investigators are not testing any new treatments in this study.

Read the detailed description

Introduction

Hypothesis

  1. Enrichment of the epigenetic markers H3K4me3 and H3K27me3 in CD14+ monocytes increases the incidence and severity of organ dysfunction after major cardiac surgery through an exaggerated postoperative inflammatory response.

To test this hypothesis, a prospective observational study recruiting 30 patients undergoing major cardiac surgery (coronary artery bypass grafting (CABG)) will be conducted to assess for association between abundance of 2 key epigenetic markers within CD14+ monocytes (H3K4me3 and H3K27me3) associated with dysregulated innate immune responses and validated clinical and biochemical measures of organ dysfunction and complications. This study will add knowledge to the recruiting multicentre prospective observational study IMPRoVE (Incidence, impact and Mechanisms of Perioperative Right VEntricular dysfunction), as a sub-study of IMPRoVE assesses epigenetic susceptibility to organ dysfunction, via the same mechanism, in patients undergoing major thoracic and vascular surgery. Epi-SICCS will therefore provide a novel opportunity to extend investigation of patients undergoing major thoracic and vascular surgery (via IMPRoVE) by studying patients undergoing major cardiac surgery (Epi-SICCS).

Background and Rationale Background

Postoperative complications are a major cause of morbidity, mortality and increased health care cost in patients undergoing elective surgery and are particularly prevalent after cardiac (57%) surgery. Further, whilst mortality and significant morbidity are easily recognised sequelae of major surgery, it is increasingly recognised that overt complications are the 'tip of the iceberg' and a significant burden of covert postoperative complications exist and have a significant long-term impact. Seeking to better understand and ameliorate this burden of complications remains a research priority.

The 'stress response' to surgical trauma results from well-choreographed activation of autonomic, neuroendocrine, metabolic, and inflammatory responses which are necessary to maintain host homeostasis and facilitate tissue repair. The hypothesis that dysregulation of this response can lead to a non-specific whole-body response (commonly referred to as systemic inflammatory response syndromes (SIRS)) is not new but its mechanisms and pathogenesis are incompletely understood.

Common to the host response to a wide variety of acute tissue injuries e.g., burns, sepsis and trauma, the concept of a 'genomic storm' occurring within hours of major surgery is increasingly recognised. This initial response affects more than 80% of cellular pathways and dynamically alters the leukocyte transcriptome with upregulation of the innate immune system and down regulation of the adaptive immune response. Whilst such a response in evolutionary terms might be considered adaptive, it can have deleterious effects on capillary permeability, immune function and wound healing and predispose to organ dysfunction.

Though simplistic, 'inflammatory markers' have historically been used to describe the magnitude of the postoperative immune response and are consistently associated with post-operative complications following cardiac, thoracic and vascular surgery. Inflammatory injury can be identified in many organs postoperatively (even those remote from the site of surgery - for example, our work demonstrating cardiac inflammation following thoracic surgery) and the magnitude of the postoperative inflammatory response has been associated with multi-organ morbidities including myocardial injury, lung injury, post operative cognitive dysfunction and kidney injury.

Transcriptomic analyses aid understanding of this 'genomic storm'; in patients undergoing major thoracoabdominal surgery Allen et al demonstrated that 522 genes were differentially expressed (in leucocytes) 24-hours after surgery; 248 (48%) were upregulated (reflecting innate immunity and inflammation) and 274 (52%) were downregulated (reflecting adaptive immunity). In this study, within-patient gene expression change was positively associated with postoperative infection and hospital length of stay; in patients where gene expression was most radically altered postoperatively, outcomes were worse.

Host susceptibility to complications

Prediction of perioperative risk is a cornerstone of perioperative medicine. Whilst individual patient and procedural risk factors for complications and mortality exist, and are widely integrated into risk prediction scores, risk prediction remains an imprecise science. Clinicians recognise the heterogeneity in the clinical response to major surgery; apparently similar patients undergoing the same surgical procedure can behave very differently during the post-operative period. This highlights the importance of differing host susceptibility to post-operative organ dysfunction.

The potential for host genomics to impact perioperative outcome has received some study, and whilst it has been possible to identify single nucleotide polymormphisms which might lead to specific perioperative morbidity syndromes (e.g. butyrylcholinesterase deficiency), it is unlikely that any single or combination of polymorphisms is responsible for the wide heterogeneity seen in patient responses to surgery. The potential value of studying genomic susceptibility to complications is further limited by the static nature of the genome; should predictors of outcome be identified, these changes are fixed with no potential for therapeutic manipulation. Because the epigenome is dynamic and as such, may be amenable to therapeutic manipulation or upstream modification, its study provides the potential to not just risk-predict, but risk-modify.

Epigenomics

Epigenomics concerns the study of how cells control gene activity without changing the DNA sequence (i.e. without altering genomic makeup). Cellular DNA is bound in chromatin as a complex of DNA and proteins. Modification of these proteins (classically by DNA methylation or histone modification) will alter the way these proteins interact with DNA and can regulate gene expression changing the way a cell responds to a stimulus.

Classical descriptions of the immune system describe the innate and adaptive responses with only the adaptive immune response being able to build immunological memory. In recent years, the potential for epigenetic reprogramming of innate immune cells in response to stimulation has been recognised. Following an initial challenge (from a pathogen or inflammatory insult), cells return to a non-activated state, but through modification of the epigenome are primed for response to a subsequent stimulus allowing rapid and enhanced recruitment of transcription factors after a secondary challenge. While much of this study has taken place in-vitro, the in-vivo corollary is that an individual's environment - the accumulated effects of aging, prior toxin ingestion, pathogen exposure and the influence of comorbidities - cumulatively influences the epigenome with the potential to fundamentally alter a cells response to a stimulus.

The CD14+ monocyte (the predominant human monocyte sub-species), whose immunological role is to 'sense and respond' is a key player in the innate immune response, reacting early to a host of stimuli. This fundamental role as trigger of the acute inflammatory response makes it a natural cell population for investigation in this setting. Moreover, due to their innate nature (i.e., immediate and prolonged response to stimuli) CD14+ monocytes are unique circulating sensors of physiological state, and thus their epigenome can provide a surrogate readout of how the wider environment has influenced the cellular state.

H3K4me3 and H3K27me3 are modifications to the DNA-packaging histone H3 which have received wide study as two key epigenetic marks accompanying trained immunity. Tri-methylation of H3K4 (the 4th lysine residue of the histone H3 protein) makes the DNA in chromatin more accessible to transcription factors, promoting gene transcription (conferring a so called 'on-state'). Conversely tri-methylation of H3K27 results in downregulation of nearby genes ('off-state'). With simultaneous presence of both H3 marks (known as bivalency), genes are referred to as 'poised'. Such a poised state confers the ability to rapidly become activated in response to a stimulus. Analogously, the engine is revving (H3K4me3), but the hand brake is on (H3K27me3). Release of the 'brake' in response to tissue injury has the potential to result in a rapid and robust immune response. Previous work by our group demonstrates wide variety in the epigenetic signature of circulating CD14+ monocytes in patients with chronic inflammatory diseases.

Whilst on an evolutionary basis, immune training should confer a survival benefit when faced with a potential pathogen, there are examples where such adaptation is deleterious, particularly where it could trigger enhanced tissue damage15. In addition to chronic inflammatory co-morbidities, common indications for cardiac surgery such as ischemic heart disease, alongside patient factors such as cigarette smoking and alcohol consumption, have the potential to serve as primary stimuli for epigenetic modification altering a patient's susceptibility to a secondary response (i.e. surgery).

The role of H3K4me3/H3K27me3 modification in the acute inflammatory response has seen limited study and the influence of such immune priming on CD14+ monocytes in the perioperative immune system response has not been explored. What data does exist, predominantly examining the effects of prior pathogen exposure (e.g. P.falciparum malaria) or inflammatory comorbidity (e.g. IHD) on the ex-vivo response to experimental sepsis speaks of a fundamental influence. Bekkering et al for example demonstrated monocytes from patients with severe symptomatic atherosclerosis (i.e. surgical candidates) to have an approximately 2-fold increase in production of pro-inflammatory cytokines upon lipo-polysaccharide stimulation compared to healthy controls, an effect which appears to be mediated by altered H3K4me3 and H3K27me3 levels on the TNFα, Interleukin-6 and -1ß promotors. Sadahiro and colleagues investigated 30 patients undergoing either major colorectal or orthopaedic surgery, performing genome-wide DNA methylation analysis perioperatively on patient peripheral blood mononuclear cells and identified distinct methylation changes associated with inflammatory gene activation triggered by surgery which persist to the day of discharge, correlating with increased inflammation. The authors discuss a limitation of their study is the diverse populations of leukocytes (monocytes, plasmablasts, CD8+ lymphocytes, CD4+ lymphocytes, Natural Killer lymphocytes) present in their analysis and caution that future studies should analyse specific cell populations (as proposed in the Epi-SCCS study) to accurately determine the inflammatory contribution of distinct leukocyte populations to major surgery. They further acknowledge that they have not performed gene expression analysis and therefore the link between DNA methylation patterns and inflammatory protein abundance is not causally explained. Laudanski et al later investigated the presence of free histones H3 and H3K4me3 and H3K27ac at several time-points (including 3-months post-operatively) in serum of 59 patients undergoing a variety of major cardiac surgeries, demonstrating the presence of "smouldering inflammation" present at 3-months after major cardiac surgery.

In summary Major surgery triggers inflammation as part of the physiological response to tissue injury, however, excessive inflammation in the post-operative period is associated with organ dysfunction, complications and morbidity. Epigenetic markers can dictate the magnitude and duration of powerful inflammatory responses. The investigators aim to study monocyte epigenetic expression, determine subsequent inflammatory gene activation/deactivation patterns (transcriptomics) and quantify inflammation (proteomics) to describe the epigenetic regulation of inflammation and its role in perioperative morbidity. Due to the modifiable nature of the epigenome, future intervention trials can then study existing or new therapies prior to surgery, to recondition the epigenome in 'at risk' patient groups as part of perioperative prehabilitation programmes, to reduce the morbidity associated with major surgery.

Keywords
Epigenetic, postoperative complications, inflammation, cardiac surgery, coronary artery bypass graft
Medical subject headings
Postoperative Complications, Inflammation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-operative organ dysfunction quantified by measurement of mean Sequential Organ Failure Assessment (SOFA) score over the first seven postoperative days.

    Measured: The first seven postoperative days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07865026
Sponsor's protocol ID
362096
Other IDs
26/LO/0117
Acronym
Epi-SICCS
Status last verified
Oct 2026
First submitted
21 Sep 2026
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data are available on reasonable request. Requests should be made to the corresponding author. All requests will be considered subject to approval of the sponsor organisation.

Questions about this trial

What is this clinical trial studying?

An observational study of Organ Dysfunction and Inflammation in Cardiac Surgery, run by University of Glasgow at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ben Shelley, MBChB Dip(Paed) FRCA FFICM MD (0141 951 5000, Benjamin.Shelley@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-operative organ dysfunction quantified by measurement of mean Sequential Organ Failure Assessment (SOFA) score over the first seven postoperative days. (time frame: The first seven postoperative days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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