Condition category
Circulatory System
Date applied
27/11/2018
Date assigned
28/11/2018
Last edited
28/11/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Emma Chung

ORCID ID

http://orcid.org/0000-0003-3723-9085

Contact details

RKCSB
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UKCRN ID: 11702

Study information

Scientific title

Brain Injury following Cardiac Interventions (BICI)

Acronym

BICI

Study hypothesis

This observational study investigates brain injury following cardiac surgery involving cardiopulmonary bypass using transcranial Doppler (TCD) ultrasound, MRI, and cognitive testing.

Ethics approval

University Hospitals of Leicester NHS Trust and Derbyshire Research Ethics Committee, 18/05/2011, ref: 10/H0401/78

Study design

Observational cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

See additional files

Condition

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

Phase

Drug names

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 trial start date

23/09/2010

Overall trial end date

25/05/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Undergoing cardiac surgery involving cardiopulmonary bypass
2. Native English speaker (for neuropsychological tests)
3. Eligible to undergo MRI scan

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

Unable to take neuropsychological tests

Recruitment start date

25/07/2011

Recruitment end date

17/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University of Leicester

Sponsor details

Dr Michelle Muessel
Research Governance Manager
Research & Enterprise Division
Research Governance Office
Fielding Johnson Building
University of Leicester
University Road
Leicester
LE1 7RH
United Kingdom
0116 252 5308
uolsponsor@le.ac.uk

Sponsor type

University/education

Website

https://le.ac.uk

Funders

Funder type

Charity

Funder name

British Heart Foundation

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

We plan to publish the results of the study as open-access original research in peer-reviewed journals.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/01/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

28/11/2018: The participant information sheet has been uploaded.