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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

866 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2020-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cardiac Defects Disorder; Heart, Functional, Postoperative, Cardiac Surgery Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Control

Routine clinical care (which includes a conventional chest X-ray).

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

CT scan

Intervention Type OTHER

The intervention group receives both standard care (chest x-ray) and an ultra low dose CT thorax without contrast.

Interventions

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CT scan

The intervention group receives both standard care (chest x-ray) and an ultra low dose CT thorax without contrast.

Intervention Type OTHER

Other Intervention Names

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computed tomography

Eligibility Criteria

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Inclusion Criteria

* 18 years old or older
* Scheduled to undergo heart surgery
* Provide written informed consent

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Annemarie den Harder

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ricardo PJ Budde, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus MC Rotterdam

Locations

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Heart and Vascular Center Semmelweis University

Budapest, , Hungary

Site Status

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status

Countries

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Hungary Netherlands

Study Documents

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Document Type: Study Protocol

Ultra low-dose chest ct with iterative reconstructions as an alternative to conventional chest x-ray prior to heart surgery (CRICKET study): Rationale and design of a multicenter randomized trial.

View Document