Cardiac Defects, Disorder; Heart, Functional, Postoperative, Cardiac Surgery, Stroke
Conditions
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.
Interventions
OTHERCT scan
The intervention group receives both standard care (chest x-ray) and an ultra low dose CT thorax without contrast.
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative stroke | 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
| Measure | Time frame | Description |
|---|---|---|
| Altered surgical approach | 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. |
Countries
Hungary, Netherlands
Outcome results
None listed