To assess if information about aortic calcification obtained from routine preoperative ultra low-dose chest CT reconstructed with IR lowers the postoperative stroke rate in patients undergoing heart surgery by optimizing surgical strategy compared…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Percentage of patients suffering from in-hospital postoperative stroke
(central neurological defect that either recovers spontaneously or is
permanent) after heart surgery.
Secondary outcome
- Percentage of patients in which the surgical approach is altered based on
information derived from the preoperative chest CT.
Background summary
During heart surgery the aorta is clamped to initiate cardiopulmonary bypass.
This may crush aortic calcifications causing them to embolize to the brain
causing a stroke
which is a devastating complication for the patient. A chest X-ray is routinely
performed prior to heart surgery. It provides no information about aortic
calcification. Imaging by a chest computed tomography (CT) scan provides
detailed information on aortic calcification but has higher radiation exposure
and thus is not used routinely. Recently iterative reconstruction (IR)
techniques have become available that allow chest CT to be performed at
markedly reduced dose with retained image quality. Routine use of low dose
chest CT with IR prior to heart surgery may identify patients with a severely
calcified aorta in which the surgery may subsequently adapted to minimize or
avoid aortic manipulation which may reduce stroke rate.
Study objective
To assess if information about aortic calcification obtained from routine
preoperative ultra low-dose chest CT reconstructed with IR lowers the
postoperative stroke rate in patients undergoing heart surgery by optimizing
surgical strategy compared to the normal work-up with a conventional chest
X-ray.
Study design
Multicenter randomized controlled trial.
Study burden and risks
For research purposes an additional low-dose CT-scan of the chest is performed
in the *intervention* group. This scan will require approximately 5 minutes in
total (including patient preparation). The additional radiation dose for
patients in the intervention group will be less than 1 mSv. Because the
low-dose scans are non-contrast enhanced there is no additional risk due to use
of contrast agents. Patients in the control group will have to do nothing
expect sign informed consent.
Patients in the intervention group may benefit directly from participating in
this study (better planning of surgery, potential of less risk of calcific
emboli to the brain). Patients in the control group do not benefit directly
from participating in this study.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- 18 years old or older
- Scheduled to undergo heart surgery
- Provide written informed consent
Exclusion criteria
- Patient not meeting inclusion criteria
- Pregnant women
- Scheduled to undergo transcatheter aortic valve insertion procedure
- Patients that underwent a chest CT in the past three months
- Emergency surgery
- Concomitant or previous participation in a study that prohibits the patient from participating in a study that exposed the patient to radiation
- Unwillingness to be informed about unrequested findings on the CT scan
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL47293.041.13 |
| OMON | NL-OMON26609 |