ISRCTN ISRCTN96327158
DOI https://doi.org/10.1186/ISRCTN96327158
Protocol serial number N0436165538
Sponsor Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders Leeds Teaching Hospitals NHS Trust (UK), NHS R&D Support Funding
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

Room 170
Cardiology Department
D Floor Jubilee Wing
Great George Street
Leeds
LS1 3EX
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleCoronary intervention dose reduction & image quality survey
Study objectivesTo 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) studiedCardiovascular: Coronary disease
InterventionNot provided at time of registration
Intervention typeOther
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/03/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration300
Key inclusion criteriaAny patient scheduled for coronary intervention is in principal eligible for inclusion as participant in the study, subject to the appropriate consent conditions.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/03/2005
Date of final enrolment01/03/2008

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes