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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Control
Routine clinical care (which includes a conventional chest X-ray).
|
|
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Eksperimentell: 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).
|
The intervention group receives both standard care (chest x-ray) and an ultra low dose CT thorax without contrast.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative stroke
Tidsramme: 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.
|
Participants will be followed for the duration of hospital stay, an expected average of 5 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Altered surgical approach
Tidsramme: The surgery will take place the day after hospital administration.
|
Percentage of patients in which the surgical approach is altered based on information derived from the preoperative chest CT.
|
The surgery will take place the day after hospital administration.
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ricardo PJ Budde, MD, PhD, Erasmus MC Rotterdam
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- NL47293.041.13
- 837001403 (Annet stipend/finansieringsnummer: ZonMw)
Plan for individuelle deltakerdata (IPD)
Studiedata/dokumenter
-
Studieprotokoll
Informasjonskommentarer: 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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