Grid removals vs. dose and image quality for diagnostic imaging on a Innova 2000 cardiac system.

ISRCTN	ISRCTN37477515
DOI	https://doi.org/10.1186/ISRCTN37477515
Protocol serial number	N0050140299
Sponsor	Department of Health
Funder	Bradford Teaching Hospitals NHS Foundation Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Henry Lindsay
Scientific

Bradford Cardiology Research Unit
Ward 22
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Phone	+44 (0)1274 364 181
Email	Steven.lindsay@bradfordhospitals.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Demonstrate a reduction in patient exposure/dose commensurate with no negative impact on diagnosis by removing antiscatter grid.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	28/07/2004

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Key inclusion criteria	1. Patients referred for diagnosis of coronary artery disease by coronary angiography . 100 2. BMI <40
Key exclusion criteria	1. Risk of pregnancy 2. Patients with suspected valve disease 3. BMI ≥ 40
Date of first enrolment	28/01/2004
Date of final enrolment	28/07/2004

Bradford Cardiology Research Unit

Bradford
BD9 6RJ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan