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 : Terminated (Expected futility in reaching the primary endpoint)
First Posted : June 25, 2014
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Defects Disorder; Heart, Functional, Postoperative, Cardiac Surgery Stroke||Other: CT scan||Not Applicable|
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)|
|Actual Enrollment :||866 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ultra Low-dose Chest CT With Iterative Reconstructions as an Alternative to Conventional Chest X-ray Prior to Heart Surgery|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||October 2019|
|Actual Study Completion Date :||June 2020|
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
- 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.
- 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.
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
|Heart and Vascular Center Semmelweis University|
|Erasmus Medical Center|
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3508GA|
|Principal Investigator:||Ricardo PJ Budde, MD, PhD||Erasmus MC Rotterdam|