Coronary Artery Disease
Conditions
Keywords
Multidetector computed tomography
Brief summary
Clinical evaluation of a new cardiovascular oriented CT scanner from Arineta Ltd.
Detailed description
The study will evaluate a new twin source relatively compact CT scanner with advanced technology which is optimized for cardiovascular imaging. Eligible patients with a clinical indication will undergo coronary or cardiac CT scans using the new SpotLight CT from Arineta Ltd. Image quality and usefulness of the new system will then be evaluated.
Interventions
OTHERCardiac CT scanning (with the SpotLight CT)
Cardiac CT scanning
Sponsors
Arineta Ltd.
Carmel Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Symptomatic patients with a clinical indication for cardiac CT 2. Patients with a clinical indication for CT 3. Estimated GFR \> 60 mL/min
Exclusion criteria
1. No clinical indication for CT scanning 2. Contra-indication for CT scanning or for IV contrast administration 3. Pregnancy 4. Inability to give an informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image quality (subjective) of the new SpotLight CT scanner from Arineta Ltd. | 2 years | Subjective (4 grade scale) image quality assessment of coronary arteries. unassessable studies and unassessable coronary segments will be reported. |
| Image quality (objective) of the new SpotLight CT scanner from Arineta Ltd. | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of the new SpotLight CT scanner from Arineta Ltd. | 2 years | Performance characteristics of the new CT scanner for diagnosing obstructive coronary artery disease as compared to other reference standards such as invasive coronary angiography. |
| The effect of cardiac CT results (with SpotLight CT) on patients triage | 5 years | The effect of cardiac CT results on patients diagnosis and therfore hospitalization or discharge decisions |
| The predictive value of cardiac CT results (with SpotLight CT) for patients outcome | 5 years | Predictive value of cardiac CT results for adverse outcomes (death/myocardial infarction/revascularization). |
Countries
Israel
Contacts
Primary ContactRonen Rubinshtein, MD
Backup ContactMali Azencot, PHD-RN
Outcome results
None listed