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

Not Applicable

Terminated

• Conditions: Cardiac Defects; Disorder; Heart, Functional, Postoperative, Cardiac Surgery; Stroke
• Interventions: Other: CT scan

• Registration Number: NCT02173470
• Lead Sponsor: UMC Utrecht

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.

Study Timeline

• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-25
• Study Start: 2014-09
• Primary Completion: 2019-10
• Status Verified: 2020-06
• Study Completion: 2020-06
• Last Update Submitted: 2020-06-08
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 866

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT scan	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Heart and Vascular Center Semmelweis University; 🇭🇺 Budapest, Hungary

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands