C.Surgical Procedure; CardiacOb-CardNCT02908009
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
An observational study of C.Surgical Procedure; Cardiac, run by University of Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- C.Surgical Procedure; Cardiac
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Sep 2016to 7 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Patients with pre-existing paroxysmal, persistent or chronic atrial fibrillation,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
England
Glenfield, Leicestershire, LE3 9QP
About this study
Official title: An Observational 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
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.
- Conditions
- C.Surgical Procedure; Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Post surgery inotrope score
inotrope score measured up to 48 hours post-surgery
Measured: inotrope score measured up to 48 hours post-surgery
Secondary outcomes (11)
Changes in expression of target genes
from right atrial biopsies
Measured: Collected at the time of surgery
Changes in epigenetic regulation of target genes from left atrial biopsies.
histone acetylation, DNA methylation
Measured: Collected at the time of surgery
Changes in mitochondrial function
in atrial biopsies and buffy coats of blood samples collected before and after surgery
Measured: before and after sugery (up to 12 hours post surgery)
Myocardial Injury
defined by post cardiac surgery serum Troponin levels
Measured: baseline and 24 hours
Acute kidney injury
defined by serum creatinine level postoperatively, as per the KDIGO criteria
Measured: baseline, and up to 15 days post surgery (discharge)
Perioperative clinical characteristics
Perioperative clinical characteristics
Measured: Collected pre op
Perioperative medications.
Perioperative medications.
Measured: Collected pre op
Data to calculate Multiple Organ Dysfunction (MOD) score.
To calculate the MOD score, the Respiratory Function (calculated as partial pressure of oxygen (PaO2) divided by fraction of inspired oxygen (FiO2)), Cardiovascular (Pressure adjusted heart rate (PAR) ), Renal (Serum Creatinine), Hepatic (serum bilirubi
Measured: baseline, and up to 96 hours post surgery
Data to capture Acute Respiratory Distress Syndrome (Berlin criteria ARDS).
Acute Lung Injury (ALI) non-ARDS, ARDS. To define these different categories of acute lung injury, the Positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) will be recorded in the CRF at time points: Pre-OP, ICU, 12 hrs post-op,24hrs post-op,48hrs post-op,72hrs post-op and 96hrs post-op. Along with the PaO2/FiO2 ratio, it will then be possible to categorise patients into the above definitions of acute lung injury as follows: ALI non-ARDS (200 mmHg <PaO2/FiO2<300 mmHg, regardless of PEEP),ARDS (PaO2/FiO2<200 mmHg, regardless of PEEP), mild Berlin Definition(200mmHg <PaO2/FiO2<300mmHg with PEEP > 5cm H2O),moderate Berlin Definition(100mmHg <calculated as partial pressure of oxygen divided by fraction of inspired oxygen PaO2/FiO2 < 200mmHg with PEEP > 5cm H2O) and Severe Berlin Definition (PaO2/FiO2 < 100mmHg with PEEP > 5cm H2O)
Measured: baseline, and up to 96 hours post surgery
Data on demographics
Height in cms
Measured: Pre Op
Data on demographics
Weight in kgs
Measured: Pre Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start9 Sep 2016
- Primary completion7 Oct 2024 (estimated)
- Study completion7 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for C.Surgical Procedure; CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gavin Murphy, Principal investigator, University of LeicesterFiliberto Serraino, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908009
- Sponsor's protocol ID
- 0574
- Acronym
- Ob-Card
- Status last verified
- Nov 2023
- First submitted
- 19 Jul 2016
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22797452Marshall 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.
PubMed 7587228Adebayo 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.
PubMed 35082386
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational 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
- ClinicalTrials.gov ID
- NCT02908009
- Acronym / sponsor ID
- Ob-Card / 0574
- Conditions
- C.Surgical Procedure; Cardiac
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 9 Sep 2016 (actual)
- Primary completion
- 7 Oct 2024 (estimated)
- Study completion
- 7 Oct 2024 (estimated)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients with pre-existing paroxysmal, persistent or chronic atrial fibrillation,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post surgery inotrope score
Time frame: inotrope score measured up to 48 hours post-surgery
inotrope score measured up to 48 hours post-surgery
11 secondary outcomes
Changes in expression of target genes
Time frame: Collected at the time of surgery
Changes in epigenetic regulation of target genes from left atrial biopsies.
Time frame: Collected at the time of surgery
Changes in mitochondrial function
Time frame: before and after sugery (up to 12 hours post surgery)
Myocardial Injury
Time frame: baseline and 24 hours
Acute kidney injury
Time frame: baseline, and up to 15 days post surgery (discharge)
Perioperative clinical characteristics
Time frame: Collected pre op
Perioperative medications.
Time frame: Collected pre op
Data to calculate Multiple Organ Dysfunction (MOD) score.
Time frame: baseline, and up to 96 hours post surgery
Data to capture Acute Respiratory Distress Syndrome (Berlin criteria ARDS).
Time frame: baseline, and up to 96 hours post surgery
Data on demographics
Time frame: Pre Op
Data on demographics
Time frame: Pre Op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Background: PubMed 22797452ARDS 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.
- Background: PubMed 7587228Marshall 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.
- Derived from this study: PubMed 35082386Adebayo 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.
- Individual participant dataSharing planned: Undecided
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Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.
C.Surgical Procedure; Cardiac
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gavin Murphy principal investigator
University of Leicester
Filiberto Serraino principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of C.Surgical Procedure; Cardiac, run by University of Leicester 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tracy Kumar (01162583039, tk98@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post surgery inotrope score (time frame: inotrope score measured up to 48 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02908009, which also lists 3 linked publications.
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 14 Nov 2023.