No registrations found.
ID
Source
Brief title
Health condition
heart surgery, complications, computed tomography, stroke, aortic calcifications, iterative reconstruction
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative in hospital stroke rate
Secondary outcome
Rate of change of surgical approach based on based on information derived from preoperative chest CT in patients undergoing heart surgery
Study objective
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 design
After completion of inclusion, all data will be analyzed.
Intervention
Patients are randomized to 2 groups: the intervention group undergoes an ultra low-dose non-contrast enhanced chest CT with IR in addition to routine care. The control group undergoes routine care (which includes a chest X-ray).
P.O. Box 85500, E01.132
A.M. Harder, den
Utrecht 3508 GA
The Netherlands
A.M.denHarder-4@umcutrecht.nl
P.O. Box 85500, E01.132
A.M. Harder, den
Utrecht 3508 GA
The Netherlands
A.M.denHarder-4@umcutrecht.nl
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 (since these patients receive a standard preoperative CT)
- 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
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4336 |
| NTR-old | NTR4533 |
| CCMO | NL47293.041.13 |
| OMON | NL-OMON45046 |
Summary results
Ultra low-dose chest ct with iterative reconstructions as an alternative to conventional chest x-ray prior to heart surgery (CRICKET study): Rationale and design of a multicenter randomized trial.
den Harder AM1, de Heer LM2, Maurovich-Horvat P3, Merkely B3, de Jong PA4, Das M5, de Wit GA6, Leiner T4, Budde RP7.
http://www.ncbi.nlm.nih.gov/pubmed/26857421