Coronary intervention dose reduction & image quality survey
| ISRCTN | ISRCTN96327158 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96327158 |
| Secondary identifying numbers | N0436165538 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 29/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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
Contact information
Dr Mohnaraj Sivanathan
Scientific
Scientific
Room 170
Cardiology Department
D Floor Jubilee Wing
Great George Street
Leeds
LS1 3EX
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Coronary intervention dose reduction & image quality survey |
| Study objectives | To evaluate the potential for reducing staff and patient X-ray dose during interventional coronary procedures (opening up blocked sections of coronary blood vessels) exploiting the improved technical properties of a new design of cardiac x-ray imaging system. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Coronary disease |
| Intervention | Not provided at time of registration |
| Intervention type | Other |
| Primary outcome measure | 1. Measurement of X-ray dose (via average DAP rates) - endpoint to establish the potential radiation dose savings to patients and staff in interventional coronary procedures. 2. Measurements of clinical image quality using a scoring protocol - endpoint to verify that an appropriate level of clinical image quality can be maintained following dose reduction. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/03/2005 |
| Completion date | 01/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 300 in total including 150 controls |
| Key inclusion criteria | Any patient scheduled for coronary intervention is in principal eligible for inclusion as participant in the study, subject to the appropriate consent conditions. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2005 |
| Date of final enrolment | 01/03/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
Leeds Teaching Hospitals NHS Trust (UK)
No information available
NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
