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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Emma Chung
Public

RKCSB
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom

ORCiD logoORCID ID 0000-0003-3723-9085

Study information

Study designObservational cross-sectional study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet ISRCTN66022965_PIS_v3a_23Aug2011.pdf
Scientific titleBrain Injury following Cardiac Interventions (BICI)
Study acronymBICI
Study objectivesThis 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) studiedCardiac surgery will Cardiopulmonary Bypass
InterventionAll 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 typeMixed
Primary outcome measureNumber 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 measures1. 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 date23/09/2010
Completion date25/05/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100
Key inclusion criteria1. Undergoing cardiac surgery involving cardiopulmonary bypass
2. Native English speaker (for neuropsychological tests)
3. Eligible to undergo MRI scan
Key exclusion criteriaUnable to take neuropsychological tests
Date of first enrolment25/07/2011
Date of final enrolment17/12/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University Hospitals of Leicester NHS Trust
Glenfield Hospital
Leicester
LE1 5WW
United Kingdom

Sponsor information

University of Leicester
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
Email uolsponsor@le.ac.uk
Website https://le.ac.uk
ROR logo "ROR" https://ror.org/04h699437

Funders

Funder type

Charity

British Heart Foundation
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 date01/01/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planWe plan to publish the results of the study as open-access original research in peer-reviewed journals.
IPD sharing planThe 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.