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

• Conditions: Coronary Artery Disease
• Interventions: Other: Cardiac CT scanning (with the SpotLight CT)

• Registration Number: NCT02616939
• Lead Sponsor: Carmel Medical Center

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.

Study Timeline

• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-11-30
• Study Start: 2016-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-23
• Last Update Posted: 2016-03-24
• Primary Completion: 2020-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with suspected cardiac disease	Cardiac CT scanning (with the SpotLight CT)	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).

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Carmel Medical Center; 🇮🇱 Haifa, Israel