Cardiac disease/coronary artery bypass grafting Circulatory System
Conditions
Interventions
Patients who consent will be required to undergo two functional MRI scans and neuro-cognitive assessments. Patients will have the first scan and neuro-cognitive assessments pre-surgery (1- 8 weeks bef
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 60-75 years 2. Electively referred for isolated coronary artery bypass grafting
Exclusion criteria
Exclusion criteria: 1. Prisoners and adults lacking capacity to consent 2. Contraindications to MR (implanted electronic devices, metallic foreign bodies, claustrophobia, body weight >140 kg or waist perimeter exceeding manufacturer's recommendations and others according to manufacturer’s recommendations and generally accepted guidelines) 3. Patients with a neurological disorder (e.g. epilepsy, Alzheimer’s, dementia and Parkinson’s disease) 4. Patients with a diagnosed psychiatric disorder (e.g. schizophrenia, psychosis), drug or alcohol addiction 5. Patients with an already identified as having cognitive impairment (e.g. memory and/or attentional deficits) as defined by psychometric assessment or a preoperative Mini-mental State Examination score < 24. The Mini-mental State Examination will be adminstered after consent but prior to any of the cognitive assessements or fMRI scan 6. Patients who have previously sustained a stroke, intra-cerebral haemorrhage, acquired brain injury 7. Patients unable to complete the cognitive assessments required for the trial e.g. due to language difficulties, visual or hearing impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in default mode network connectivity in the brain post cardiac surgery as assessed by resting state fMRI performed 5-10 weeks post operatively | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in cognitive ability as assessed by standard neurocognitive tests administered 5- 10 weeks post operatively 2. Length of intensive care unit (ICU)/high dependency unit (HDU) stay. This outcome is assessed during the patient’s hospital stay after their surgery. 3. All-cause mortality within 30 days of surgery 4. Clinical outcomes (assessed from surgery until follow up visit 5- 10 weeks post-surgery), defined as: 4.1. Infectious complications i.e. sepsis (defined antibiotic treatment for suspected infection, and the presence of SIRS1 within 24 hours prior to start of antibiotic treatment) or wound infection (ASEPSIS score >20; sternum, leg and arm (if applicable); wounds will be assessed at least once during a participant’s hospital stay 4.2. Stroke (validated by CT scanning); assessment of brain imaging (CT or MRI), in association with new onset focal or generalised neurological deficit (defined as deficit in motor, sensory or co-ordination functions) 4.3. ST elevation myocardial infarction accompanied by troponin > 5 ng / ml 4.4. Post-operative acute kidney injury (defined as AKIN criteria stage 1, 2 or 3) 4.5. Respiratory complications i.e. re-intubation, ventilation The study will also assess the relationship between cognitive decline assessed by the neurocognitive tests (secondary outcome 1) and changes in resting state network connectivity assessed by fMRI (primary outcome). | — |
Countries
England, United Kingdom
Contacts
Public ContactJonathan Evans
Outcome results
None listed