Clinical In-hospital Evaluation of the Usefulness of a New Multi-detector Computed Tomography Scanner From Arineta Ltd

Study Overview
=================
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.

Official Title
-----------------
Clinical In-hospital Evaluation of the Usefulness of a New Multi-detector Computed Tomography Scanner From Arineta Ltd

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: Cardiac CT scanning (with the SpotLight CT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic patients with a clinical indication for cardiac CT Patients with a clinical indication for CT Estimated GFR > 60 mL/min Exclusion Criteria: No clinical indication for CT scanning Contra-indication for CT scanning or for IV contrast administration Pregnancy Inability to give an informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with suspected cardiac disease<br>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). | Other: Cardiac CT scanning (with the SpotLight CT)<br>* Cardiac CT scanning<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of the new SpotLight CT scanner from Arineta Ltd. | Performance characteristics of the new CT scanner for diagnosing obstructive coronary artery disease as compared to other reference standards such as invasive coronary angiography. | 2 years | 
| The effect of cardiac CT results (with SpotLight CT) on patients triage | The effect of cardiac CT results on patients diagnosis and therfore hospitalization or discharge decisions | 5 years | 
| The predictive value of cardiac CT results (with SpotLight CT) for patients outcome | Predictive value of cardiac CT results for adverse outcomes (death/myocardial infarction/revascularization). | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multidetector computed tomography