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…
ID
Bron
Verkorte titel
Aandoening
heart surgery, complications, computed tomography, stroke, aortic calcifications, iterative reconstruction
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Postoperative in hospital stroke rate
Doel van het onderzoek
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.
Onderzoeksopzet
After completion of inclusion, all data will be analyzed.
Onderzoeksproduct en/of interventie
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).
Publiek
P.O. Box 85500, E01.132
A.M. Harder, den
Utrecht 3508 GA
The Netherlands
A.M.denHarder-4@umcutrecht.nl
Wetenschappelijk
P.O. Box 85500, E01.132
A.M. Harder, den
Utrecht 3508 GA
The Netherlands
A.M.denHarder-4@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 18 years old or older
- Scheduled to undergo heart surgery
- Provide written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4336 |
NTR-old | NTR4533 |
CCMO | NL47293.041.13 |
OMON | NL-OMON45046 |
Samenvatting resultaten
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