Study Stopped
Expected futility in reaching the primary endpoint
Chest CT With Iterative Reconstruction as an Alternative to Conventional Chest X-ray Prior to Heart Surgery
CRICKET
Ultra Low-dose Chest CT With Iterative Reconstructions as an Alternative to Conventional Chest X-ray Prior to Heart Surgery
2 other identifiers
interventional
866
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2014
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2014
CompletedFirst Posted
Study publicly available on registry
June 25, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJune 11, 2020
June 1, 2020
5.1 years
June 17, 2014
June 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative stroke
Percentage of patients suffering from in-hospital postoperative stroke (central neurological defect that either recovers spontaneously or is permanent) after heart surgery.
Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary Outcomes (1)
Altered surgical approach
The surgery will take place the day after hospital administration.
Study Arms (2)
Control
NO INTERVENTIONRoutine clinical care (which includes a conventional chest X-ray).
CT scan
EXPERIMENTALRoutine clinical care, which includes a chest x-ray, with an additional ultra low-dose non contrast enhanced chest CT with IR (performed preoperatively).
Interventions
The intervention group receives both standard care (chest x-ray) and an ultra low dose CT thorax without contrast.
Eligibility Criteria
You may qualify if:
- years old or older
- Scheduled to undergo heart surgery
- Provide written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Heart and Vascular Center Semmelweis University
Budapest, Hungary
Erasmus Medical Center
Rotterdam, Netherlands
University Medical Center Utrecht
Utrecht, 3508GA, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ricardo PJ Budde, MD, PhD
Erasmus MC Rotterdam
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 17, 2014
First Posted
June 25, 2014
Study Start
September 1, 2014
Primary Completion
October 1, 2019
Study Completion
June 1, 2020
Last Updated
June 11, 2020
Record last verified: 2020-06