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

C.Surgical Procedure; Cardiac Clinical Trial

— Ob-Card  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02908009
• Other study ID #: 0574
• Status: Recruiting
• Start date: September 9, 2016
• Est. completion date: October 7, 2024

Study information

• Verified date: November 2023
• Source: University of Leicester
• Contact: Tracy Kumar
• Phone: 01162583039
• Email: tk98[@]leicester.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The study aims to test several inter-related hypotheses in a consecutive sequence of patients undergoing coronary artery bypass grafting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 7, 2024
• Est. primary completion date: October 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• C.Surgical Procedure; Cardiac
• Obesity

Locations

Country	Name	City	State
United Kingdom	England	Glenfield	Leicestershire

Sponsors (1)

Lead Sponsor	Collaborator
University of Leicester

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post surgery inotrope score	inotrope score measured up to 48 hours post-surgery	inotrope score measured up to 48 hours post-surgery
Secondary	Changes in expression of target genes	from right atrial biopsies	Collected at the time of surgery
Secondary	Changes in epigenetic regulation of target genes from left atrial biopsies.	histone acetylation, DNA methylation	Collected at the time of surgery
Secondary	Changes in mitochondrial function	in atrial biopsies and buffy coats of blood samples collected before and after surgery	before and after sugery (up to 12 hours post surgery)
Secondary	Myocardial Injury	defined by post cardiac surgery serum Troponin levels	baseline and 24 hours
Secondary	Acute kidney injury	defined by serum creatinine level postoperatively, as per the KDIGO criteria	baseline, and up to 15 days post surgery (discharge)
Secondary	Perioperative clinical characteristics	Perioperative clinical characteristics	Collected pre op
Secondary	Perioperative medications.	Perioperative medications.	Collected pre op
Secondary	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	baseline, and up to 96 hours post surgery
Secondary	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	baseline, and up to 96 hours post surgery
Secondary	Data on demographics	Height in cms	Pre Op
Secondary	Data on demographics	Weight in kgs	Pre Op