The objective of the study is to assess image quality and diagnostic information of images during coronairy angiography with lower X-ray dose compared to standard dose.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Simultaneous visual comparison of image quality of the two groups by blinded
reviewers. Image quality is assessed by a specific test protocol.
In addition radiation dose will be compared between the two groups.
Secondary outcome
not applicable
Background summary
X-ray radiation is inevitable for diagnosis and/or treatment of coronary
arteries. Procedures with X-ray radiation can lead to radiation damage of
tissue. Therefore reduction of X-ray radiation is important during X-ray
investigation of the heart however image quality is directly related to X-ray
dose used for obtaining these images. In this study we investigate X-ray dose
reduction in combination with image quality.
Study objective
The objective of the study is to assess image quality and diagnostic
information of images during coronairy angiography with lower X-ray dose
compared to standard dose.
Study design
Study design: Patient controlled
Masking: randomised blinded review
Primary purpose: Diagnostic
Study burden and risks
It can be harmful to be exposed to high X-ray intensities. Also being exposed
to X-ray can be harmful if it occurs for a long time.
Furthermore contrast agent can damage kidneys if used in large quantities. The
burden to the patient who participated in this study consists of an additional
contrast injection under X-ray guidance. This will prolong the total procedure
time with 1.5 minute.
The radiation exposure during the additional contrast injection will be
limited, as a low-dose protocol will be used. Additional radiation exposure to
the patient will only occur if the image quality of the low-dose protocol
proves insufficient, and the procedure thus needs to be finished with the
standard dose. If the additional series with the low dose protocol proves to be
sufficient quality, the procedure will be completed with that of low dose
settings. The total radiation dose during the procedure will then be
significantly lower than with the standard treatment.
The additional contrast use will be about 5%-10%
Geert Grooteplein 10
Nijmegen 6525GA
NL
Geert Grooteplein 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
patients older than 18 years of age undergoing coronary angiography
Exclusion criteria
1. patient not willing or unable to give consent to participate
2. patients under the age of 18
3. pregnant women or breastfeeding women
4. patients with severe kidney disease (e-GDFR < 50 by MDRD and/or upon decision by investigator)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44509.091.13 |