Condition category
Circulatory System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
01/07/2010
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 Henry Lindsay

ORCID ID

Contact details

Bradford Cardiology Research Unit
Ward 22
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
+44 (0)1274 364 181
Steven.lindsay@bradfordhospitals.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0050140299

Study information

Scientific title

Acronym

Study hypothesis

Demonstrate a reduction in patient exposure/dose commensurate with no negative impact on diagnosis by removing antiscatter grid.

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

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Coronary artery disease

Intervention

Patients referred for diagnosis of coronary artery disease and with a Body Mass Index of less than 40 will be randomised into two groups. One group will receive the standard technique with grid, the other group will receive the modified (lower skin dose) technique without the grid. Post diagnosis images acquired will be double blindly reviewed for image quality.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Successful diagnosis of disease
2. Lower skin dose to the patient
3. Lower exposure to members of staff monitored during the trial as the employer is required to do by IRR1999 regulation 8(1)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

28/01/2004

Overall trial end date

28/07/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients referred for diagnosis of coronary artery disease by coronary angiography . 100 2. BMI <40

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 recruited locally

Participant exclusion criteria

1. Risk of pregnancy
2. Patients with suspected valve disease
3. BMI ≥ 40

Recruitment start date

28/01/2004

Recruitment end date

28/07/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bradford Cardiology Research Unit
Bradford
BD9 6RJ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Bradford Teaching Hospitals NHS Foundation 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

No publications intended as of 01/07/10

Publication citations

Additional files

Editorial Notes