Condition category
Circulatory System
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
29/01/2015
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 Mohnaraj Sivanathan

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436165538

Study information

Scientific title

Coronary intervention dose reduction & image quality survey

Acronym

Study hypothesis

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

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

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiovascular: Coronary disease

Intervention

Not provided at time of registration

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/03/2005

Overall trial end date

01/03/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300 in total including 150 controls

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/03/2005

Recruitment end date

01/03/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
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

Hospital/treatment centre

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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

Publication citations

Additional files

Editorial Notes