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Chest CT With Iterative Reconstruction as an Alternative to Conventional Chest X-ray Prior to Heart Surgery (CRICKET)

8. juni 2020 opdateret af: Annemarie den Harder, UMC Utrecht

Ultra Low-dose Chest CT With Iterative Reconstructions as an Alternative to Conventional Chest X-ray Prior to Heart Surgery

To assess if information about aortic calcification obtained from routine preoperative ultra low-dose chest CT lowers the postoperative stroke rate in patients undergoing heart surgery by optimizing surgical strategy compared to the normal work-up with a conventional chest X-ray.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

866

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Holland
      • Rotterdam, Holland
        • Erasmus Medical Center
      • Utrecht, Holland, 3508GA
        • University Medical Center Utrecht
  • Ungarn
      • Budapest, Ungarn
        • Heart and Vascular Center Semmelweis University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control
Routine clinical care (which includes a conventional chest X-ray).
Eksperimentel: 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).
Andet: CT scan
The intervention group receives both standard care (chest x-ray) and an ultra low dose CT thorax without contrast.
Andre navne:
  • computertomografi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

UMC Utrecht

Samarbejdspartnere

ZonMw: The Netherlands Organisation for Health Research and Development

Efterforskere

  • Ledende efterforsker: Ricardo PJ Budde, MD, PhD, Erasmus MC Rotterdam

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2014

Primær færdiggørelse (Faktiske)

1. oktober 2019

Studieafslutning (Faktiske)

1. juni 2020

Datoer for studieregistrering

Først indsendt

17. juni 2014

Først indsendt, der opfyldte QC-kriterier

24. juni 2014

Først opslået (Skøn)

25. juni 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2020

Sidst verificeret

1. juni 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • NL47293.041.13
  • 837001403 (Andet bevillings-/finansieringsnummer: ZonMw)

Plan for individuelle deltagerdata (IPD)

Studiedata/dokumenter

  1. Studieprotokol
    Oplysningskommentarer: 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.

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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