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

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ClinicalTrials.gov Identifier: NCT02173470
Recruitment Status : Recruiting
First Posted : June 25, 2014
Last Update Posted : January 11, 2018
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Annemarie den Harder, UMC Utrecht

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiac Defects Disorder; Heart, Functional, Postoperative, Cardiac Surgery Stroke Other: CT scan Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1724 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ultra Low-dose Chest CT With Iterative Reconstructions as an Alternative to Conventional Chest X-ray Prior to Heart Surgery
Study Start Date : July 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Arm Intervention/treatment
No Intervention: Control
Routine clinical care (which includes a conventional chest X-ray).
Experimental: 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).
Other: CT scan
The intervention group receives both standard care (chest x-ray) and an ultra low dose CT thorax without contrast.
Other Name: computed tomography




Primary Outcome Measures :
  1. Postoperative stroke [ Time Frame: 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.


Secondary Outcome Measures :
  1. Altered surgical approach [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02173470


Contacts
Contact: Wiebe Knol, MD w.knol@erasmusmc.nl

Locations
Hungary
Heart and Vascular Center Semmelweis University Recruiting
Budapest, Hungary
Contact: Wiebe G. Knol, MD       w.knol@erasmusmc.nl   
Contact       w.knol@erasmusmc.nl   
Principal Investigator: Pal Maurovich-Horvat, MD, PhD         
Netherlands
Maastricht University Medical Center Active, not recruiting
Maastricht, Netherlands, 6229 HX
Erasmus Medical Center Not yet recruiting
Rotterdam, Netherlands
Contact: Wiebe G. Knol       w.knol@erasmusmc.nl   
Principal Investigator: Ricardo PJ Budde, MD, PhD         
University Medical Center Utrecht Active, not recruiting
Utrecht, Netherlands, 3508GA
Sponsors and Collaborators
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Ricardo PJ Budde, MD, PhD Erasmus MC Rotterdam

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
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.

Responsible Party: Annemarie den Harder, MD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02173470     History of Changes
Other Study ID Numbers: NL47293.041.13
837001403 ( Other Grant/Funding Number: ZonMw )
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018