Contact information
Type
Scientific
Primary contact
Dr Andrew Iversen
ORCID ID
Contact details
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
+44 01273 696955
andrew.iversen@bsuh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0051117057
Study information
Scientific title
Acronym
Study hypothesis
1. That using portable ultrasound to identify carotid atheroma in patients attending a hospital lipid clinic is feasible and acceptable to patients
2. That images of carotid atheroma motivate patients to engage in behaviours to reduce the risk of cardiovascular disease
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Cardiovascular: Carotid atheroma
Intervention
A between subjects design in which 200 patients will be randomly allocated to one of two groups: (1) scanned (2) not scanned. Assuming that ultrasound will detect plaque in 50% of patients, this sample gives sufficient power to detect a medium effect size. Between group comparisons will be of cognitions known to precede behaviour change (ie prescriptions of severity of cardiovascular disease, risk and response efficacy (ie giving up smoking will reduce risk), understanding of the results of the scan, acceptability of the scan and fear. Prevalence of carotid atheroma and recruitment rates will be recorded.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
If successful the results in this study will be used to develop a randomised controlled trial of the impact of imaging carotid atheroma to motivate cardiovascular risk reducing behaviour change.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2002
Overall trial end date
01/09/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
200 patients attending a routine lipid clinic.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
200
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2002
Recruitment end date
01/09/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Brighton and Sussex University Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2004 results in:
Carotid ultrasound examination as a diagnostic and motivational tool in vascular risk factor clinics. Wijeratne S, Iversen A, Hall S, Hall S. Atherosclerosis 2004;5:158-9.