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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02173470
Recruitment Status : Terminated (Expected futility in reaching the primary endpoint)
First Posted : June 25, 2014
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Annemarie den Harder, UMC Utrecht

Tracking Information
First Submitted Date  ICMJE June 17, 2014
First Posted Date  ICMJE June 25, 2014
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE September 2014
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chest CT With Iterative Reconstruction as an Alternative to Conventional Chest X-ray Prior to Heart Surgery
Official Title  ICMJE Ultra Low-dose Chest CT With Iterative Reconstructions as an Alternative to Conventional Chest X-ray Prior to Heart Surgery
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Cardiac Defects
  • Disorder; Heart, Functional, Postoperative, Cardiac Surgery
  • Stroke
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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).
    Intervention: Other: CT scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 8, 2020)
866
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2014)
1724
Actual Study Completion Date  ICMJE June 2020
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02173470
Other Study ID Numbers  ICMJE NL47293.041.13
837001403 ( Other Grant/Funding Number: ZonMw )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Annemarie den Harder, UMC Utrecht
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE ZonMw: The Netherlands Organisation for Health Research and Development
Investigators  ICMJE
Principal Investigator: Ricardo PJ Budde, MD, PhD Erasmus MC Rotterdam
PRS Account UMC Utrecht
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP