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

Recruiting

Phase N/A Results N/A

Update History

1 Nov '17
The description was updated.
New
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.
Old
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.
The gender criteria for eligibility was updated to "All."
13 Feb '16
A location was updated in Budapest.
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The overall status was updated to "Recruiting" at Heart and Vascular Center Semmelweis University.
A location was updated in Maastricht.
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The overall status was updated to "Recruiting" at Maastricht University Medical Center.
4 Dec '15
The Summary of Purpose was updated.
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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.
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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.
29 May '15
The eligibility criteria were updated.
New
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
Old
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) - 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
4 Sep '14
A location was updated in Utrecht.
New
The overall status was updated to "Recruiting" at University Medical Center Utrecht.
2 Jul '14
Trial name was updated.
New
Chest CT With Iterative Reconstruction as an Alternative to Conventional Chest X-ray Prior to Heart Surgery