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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02173470|
Recruitment Status : Recruiting
First Posted : June 25, 2014
Last Update Posted : January 11, 2018
|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)|
|Estimated Enrollment :||1724 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|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
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
|Contact: Wiebe Knol, MDfirstname.lastname@example.org|
|Heart and Vascular Center Semmelweis University||Recruiting|
|Contact: Wiebe G. Knol, MD email@example.com|
|Principal Investigator: Pal Maurovich-Horvat, MD, PhD|
|Maastricht University Medical Center||Active, not recruiting|
|Maastricht, Netherlands, 6229 HX|
|Erasmus Medical Center||Not yet recruiting|
|Contact: Wiebe G. Knol firstname.lastname@example.org|
|Principal Investigator: Ricardo PJ Budde, MD, PhD|
|University Medical Center Utrecht||Active, not recruiting|
|Utrecht, Netherlands, 3508GA|
|Principal Investigator:||Ricardo PJ Budde, MD, PhD||Erasmus MC Rotterdam|