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Lage dosis CT scan voor een hartoperatie


- candidate number17555
- NTR NumberNTR4533
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-apr-2014
- Secondary IDsNL47293.041.13 (METC) 837001403 (ZonMW)
- Public TitleLage dosis CT scan voor een hartoperatie
- Scientific TitleUltra low-dose chest CT with iterative reconstructions as an alternative to conventional chest x-ray prior to heart surgery’
- ACRONYMCRICKET studie
- hypothesisDuring 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.
- Healt Condition(s) or Problem(s) studiedCardiac surgery, Complications, Computed tomography, Stroke, Aortic calcifications
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-jun-2014
- planned closingdate1-jun-2017
- Target number of participants1724
- InterventionsPatients 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).
- Primary outcomePostoperative in hospital stroke rate
- Secondary outcomeRate of change of surgical approach based on based on information derived from preoperative chest CT in patients undergoing heart surgery
- TimepointsAfter completion of inclusion, all data will be analyzed.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD A.M. Harder, den
- CONTACT for SCIENTIFIC QUERIESMD A.M. Harder, den
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsJ Cardiovasc Comput Tomogr. 2016 Jan 30. pii: S1934-5925(16)30015-6. doi: 10.1016/j.jcct.2016.01.016. [Epub ahead of print] 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
- Brief summary
- Main changes (audit trail)
- RECORD23-apr-2014 - 14-feb-2016


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