Clinical In-hospital Evaluation of the Usefulness of a New Multi-detector Computed Tomography Scanner From Arineta Ltd
Arineta
1 other identifier
observational
400
1 country
1
Brief Summary
Clinical evaluation of a new cardiovascular oriented CT scanner from Arineta Ltd.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
Longer than P75 for all trials
1 active site
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
November 23, 2015
CompletedFirst Posted
Study publicly available on registry
November 30, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedMarch 24, 2016
March 1, 2016
4.8 years
November 23, 2015
March 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Image quality (subjective) of the new SpotLight CT scanner from Arineta Ltd.
Subjective (4 grade scale) image quality assessment of coronary arteries. unassessable studies and unassessable coronary segments will be reported.
2 years
Image quality (objective) of the new SpotLight CT scanner from Arineta Ltd.
Image contrast, image noise, signal to noise ratio and contrast to noise ratio. Those numerical values will be reported to allow comparisons with values previously reported with other CT scanners.
2 years
Secondary Outcomes (3)
Diagnostic accuracy of the new SpotLight CT scanner from Arineta Ltd.
2 years
The effect of cardiac CT results (with SpotLight CT) on patients triage
5 years
The predictive value of cardiac CT results (with SpotLight CT) for patients outcome
5 years
Study Arms (1)
Patients with suspected cardiac disease
Patients eligible for cardiac CT will be included with a focus on symptomatic patients with low-intermediate risk for obstructive coronary artery disease. Patients will undergo Cardiac CT scanning (with the SpotLight CT).
Interventions
Cardiac CT scanning
Eligibility Criteria
Patients with a clinical indication for cardiac CT
You may qualify if:
- Symptomatic patients with a clinical indication for cardiac CT
- Patients with a clinical indication for CT
- Estimated GFR \> 60 mL/min
You may not qualify if:
- No clinical indication for CT scanning
- Contra-indication for CT scanning or for IV contrast administration
- Pregnancy
- Inability to give an informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carmel Medical Centerlead
- Arineta Ltd.collaborator
Study Sites (1)
Carmel Medical Center
Haifa, 34362, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronen Rubinshtein, MD
Carmel Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2015
First Posted
November 30, 2015
Study Start
January 1, 2016
Primary Completion
November 1, 2020
Study Completion
November 1, 2022
Last Updated
March 24, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share