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

Coronary Artery Disease Clinical Trial

— Arineta  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02616939
• Other study ID #: CMC-14-0127-CTIL
• Status: Recruiting
• Phase: N/A
• First received: November 23, 2015
• Last updated: March 23, 2016
• Start date: January 2016
• Est. completion date: November 2022

Study information

• Verified date: March 2016
• Source: Carmel Medical Center
• Contact: Ronen Rubinshtein, MD
• Phone: +972-4-8250153
• Email: ronenrub[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Clinical evaluation of a new cardiovascular oriented CT scanner from Arineta Ltd.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 2022
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Cardiac CT scanning (with the SpotLight CT)
Cardiac CT scanning

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Carmel Medical Center	Arineta Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No