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

Sponsor
UMC Utrecht (Other)
Overall Status
Terminated
CT.gov ID
NCT02173470
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development (Other)
866
Enrollment
3
Locations
2
Arms
69
Actual Duration (Months)
288.7
Patients Per Site
4.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: CT scan
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
866 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Ultra Low-dose Chest CT With Iterative Reconstructions as an Alternative to Conventional Chest X-ray Prior to Heart Surgery
Actual Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Oct 1, 2019
Actual Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

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

Other: CT scan
The intervention group receives both standard care (chest x-ray) and an ultra low dose CT thorax without contrast.
Other Names:
  • computed tomography

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Heart and Vascular Center Semmelweis University Budapest Hungary
    2 Erasmus Medical Center Rotterdam Netherlands
    3 University Medical Center Utrecht Utrecht Netherlands 3508GA

    Sponsors and Collaborators

    • UMC Utrecht
    • ZonMw: The Netherlands Organisation for Health Research and Development

    Investigators

    • Principal Investigator: Ricardo PJ Budde, MD, PhD, Erasmus MC Rotterdam

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Annemarie den Harder, MD, UMC Utrecht
    ClinicalTrials.gov Identifier:
    NCT02173470
    Other Study ID Numbers:
    • NL47293.041.13
    • 837001403
    First Posted:
    Jun 25, 2014
    Last Update Posted:
    Jun 11, 2020
    Last Verified:
    Jun 1, 2020

    Study Results

    No Results Posted as of Jun 11, 2020