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

This study is currently recruiting participants.
Verified October 2017 by Annemarie den Harder, UMC Utrecht
Sponsor:
ClinicalTrials.gov Identifier:
NCT02173470
First Posted: June 25, 2014
Last Update Posted: October 30, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Annemarie den Harder, UMC Utrecht
  Purpose
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 Intervention
Cardiac Defects Disorder; Heart, Functional, Postoperative, Cardiac Surgery Stroke Other: CT scan

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Annemarie den Harder, UMC Utrecht:

Primary Outcome Measures:
  • 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:
  • 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.


Estimated Enrollment: 1724
Study Start Date: July 2014
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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: Annemarie M. den Harder, MD a.m.denharder@umcutrecht.nl

Locations
Hungary
Heart and Vascular Center Semmelweis University Recruiting
Budapest, Hungary
Contact: Annemarie M den Harder, MD         
Contact: Annemarie M den harder, MD       a.m.denharder@umcutrecht.nl   
Principal Investigator: Pal Maurovich-Horvat, MD, PhD         
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Netherlands, 6229 HX
Contact: Annemarie M. den Harder, MD       a.m.denharder@umcutrecht.nl   
Principal Investigator: Marco Das, MD, PhD         
Erasmus Medical Center Not yet recruiting
Rotterdam, Netherlands
Contact: Annemarie M den Harder, MD       a.m.denharder@umcutrecht.nl   
Principal Investigator: Ricardo PJ Budde, MD, PhD         
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3508GA
Contact: Annemarie M. den Harder, MD       a.m.denharder@umcutrecht.nl   
Principal Investigator: Ricardo PJ Budde, MD, PhD         
Sponsors and Collaborators
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Ricardo PJ Budde, MD, PhD UMC Utrecht
  More Information

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 Submitted: June 17, 2014
First Posted: June 25, 2014
Last Update Posted: October 30, 2017
Last Verified: October 2017