Chest CT With Iterative Reconstruction as an Alternative to Conventional Chest X-ray Prior to Heart Surgery (CRICKET)
Ultra Low-dose Chest CT With Iterative Reconstructions as an Alternative to Conventional Chest X-ray Prior to Heart Surgery
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
In this multicenter randomized controlled clinical trial the effect of preoperative chest CT on postoperative stroke is investigated. In total 1724 patients will be included of whom 862 patients will receive an additional CT to standard care and 862 patients will receive routine care.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
- Chest or cardiac 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Geen tussenkomst: Control
Routine clinical care (which includes a conventional chest X-ray).
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Experimenteel: CT scan
Routine clinical care, which includes a chest x-ray, with an additional ultra low-dose non contrast enhanced chest CT with IR (performed preoperatively).
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The intervention group receives both standard care (chest x-ray) and an ultra low dose CT thorax without contrast.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Postoperative stroke
Tijdsspanne: Participants will be followed for the duration of hospital stay, an expected average of 5 days
|
Percentage of patients suffering from in-hospital postoperative stroke (central neurological defect that either recovers spontaneously or is permanent) after heart surgery.
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Participants will be followed for the duration of hospital stay, an expected average of 5 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Altered surgical approach
Tijdsspanne: The surgery will take place the day after hospital administration.
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Percentage of patients in which the surgical approach is altered based on information derived from the preoperative chest CT.
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The surgery will take place the day after hospital administration.
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Ricardo PJ Budde, MD, PhD, Erasmus MC Rotterdam
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- NL47293.041.13
- 837001403 (Ander subsidie-/financieringsnummer: ZonMw)
Plan Individuele Deelnemersgegevens (IPD)
Bestudeer gegevens/documenten
-
Leerprotocool
Informatie opmerkingen: 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.
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