Causes of brain injury during heart surgery
| ISRCTN | ISRCTN66022965 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66022965 |
| Secondary identifying numbers | UKCRN ID: 11702 |
- Submission date
- 27/11/2018
- Registration date
- 28/11/2018
- Last edited
- 06/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Brain injury is a well known risk of heart surgery, but the exact causes are poorly understood. The aim of this study is to detect new brain injuries following heart surgery using an MRI brain scan, and by asking patients to perform a series of puzzles and language tasks assessing memory and brain function. Tests will be performed before and after surgery for comparison with the patients' medical records and type of surgery to help identify the causes of brain injury.
Who can participate?
Patients having heart surgery can join the study if it is safe for them to have an MRI scan, and their level of English is sufficient to complete the language tasks.
What does the study involve?
The study involves having an MRI brain scan lasting around 30 mins, and undergoing a series of puzzles and tests lasting approximately 1 hour. The brain scan and tests are performed twice: before the operation, and then 6-8 weeks afterwards. This will allow the study team to confidently identify new brain injuries. Patients also receive monitoring of brain blood flow during surgery using ultrasound, and we will obtain information about the patient's risk factors and type of surgery from medical records to explore potential causes of brain injury.
What are the possible benefits and risks of participating?
The MRI and ultrasound monitoring methods used in this study are low-risk and not harmful. If the brain MRI scan reveals any unexpected medical problems we will notify the patient's doctor. Otherwise, there are no direct benefits to the patient, although the results of our research may benefit patients in the future.
Where is the study run from?
This study takes place at Leicester Glenfield Hospital.
When is the study starting and how long is it expected to run for?
September 2010 to December 2014
Who is funding the study?
The British Heart Foundation
Who is the main contact?
The main contact is Dr Emma Chung, Lecturer, Department of Cardiovascular Sciences, University of Leicester. emlc1@le.ac.uk
Contact information
Public
RKCSB
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
 ORCID ID |
0000-0003-3723-9085 |
|---|
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN66022965_PIS_v3a_23Aug2011.pdf |
| Scientific title | Brain Injury following Cardiac Interventions (BICI) |
| Study acronym | BICI |
| Study objectives | This observational study investigates brain injury following cardiac surgery involving cardiopulmonary bypass using transcranial Doppler (TCD) ultrasound, MRI, and cognitive testing. |
| Ethics approval(s) | University Hospitals of Leicester NHS Trust and Derbyshire Research Ethics Committee, 18/05/2011, ref: 10/H0401/78 |
| Health condition(s) or problem(s) studied | Cardiac surgery will Cardiopulmonary Bypass |
| Intervention | All eligible participants are invited to take part in the study after their cardiac surgery consultation and provided with a patient information leaflet. Participants interested in taking part in the research study are scheduled in for an MRI scan and a battery of cognitive tests prior to their surgical procedure. All participants undergo intra-operative bi-lateral transcranial ultrasound monitoring of the middle cerebral artery during their cardiac surgery. This ultrasound recording of the blood flow of the cerebral arteries is recorded for the entire procedure. The participants are invited for a follow-up 6 to 8 weeks after surgery, which includes a second MRI scan and the same battery of cognitive tests. On completion, this completes the participants involvement in the study. |
| Intervention type | Mixed |
| Primary outcome measure | Number and size of brain lesions assessed using 3T MRI imaging (including diffusion-weighted imaging, fluid-attenuated inversion recovery, time of flight angiography, susceptible weighted imaging and T1 and T2 volumetric measurements) before surgery and 6-8 weeks post-surgery |
| Secondary outcome measures | 1. Cognitive ability (including speed of information and language processing, attention and psychomotor speed) assessed using WASI test (via Block Design, Pattern Matrices, and Similarities and Vocabulary tests), Trail Making Parts A and B, WMS-III digit span task, SCOLP test and Grooved Pegboard test before surgery and 6-8 weeks post-surgery 2. Interruption to blood flow to the brain and presence of emboli during the surgical procedure assessed using intra-operative transcranial ultrasound monitoring of the middle cerebral artery 3. Presence/absence of risk factors for cognitive decline assessed by reviewing the participant's medical records |
| Overall study start date | 23/09/2010 |
| Completion date | 25/05/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Undergoing cardiac surgery involving cardiopulmonary bypass 2. Native English speaker (for neuropsychological tests) 3. Eligible to undergo MRI scan |
| Key exclusion criteria | Unable to take neuropsychological tests |
| Date of first enrolment | 25/07/2011 |
| Date of final enrolment | 17/12/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leicester
LE1 5WW
United Kingdom
Sponsor information
University/education
Dr Michelle Muessel
Research Governance Manager
Research & Enterprise Division, Research Governance Office
Fielding Johnson Building
University of Leicester
University Road
Leicester
LE1 7RH
England
United Kingdom
| Phone | 0116 252 5308 |
|---|---|
| uolsponsor@le.ac.uk | |
| Website | https://le.ac.uk |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | We plan to publish the results of the study as open-access original research in peer-reviewed journals. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v3 | 23/08/2011 | 28/11/2018 | No | Yes |
| Results article | results | 01/02/2019 | Yes | No | |
| Results article | results | 15/09/2020 | 06/07/2020 | Yes | No |
Additional files
- ISRCTN66022965_PIS_v3a_23Aug2011.pdf
- Uploaded 28/11/2018
Editorial Notes
06/07/2020: Publication reference added.
02/01/2019: Publication reference added.
19/12/2018: Internal review.
28/11/2018: The participant information sheet has been uploaded.
