An interventional study of CT scan in Cardiac Defects, Disorder; Heart, Functional, Postoperative, Cardiac Surgery and Stroke, sponsored by UMC Utrecht. Terminated at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by UMC Utrecht · Not applicable, Interventional, and Diagnostic
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.
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 866 is above the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →UMC Utrecht is the lead sponsor of 363 studies on the registry; 81 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Routine clinical care (which includes a conventional chest X-ray).
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.
Also known as: computed tomography
Postoperative stroke
Percentage of patients suffering from in-hospital postoperative stroke (central neurological defect that either recovers spontaneously or is permanent) after heart surgery.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Altered surgical approach
Percentage of patients in which the surgical approach is altered based on information derived from the preoperative chest CT.
Time frame: The surgery will take place the day after hospital administration.
Ran from Sep 2014 to primary completion in Oct 2019, 61 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.