Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
26/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

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.

Publication citations

Additional files

Editorial Notes