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

March 23, 2016 updated by: Carmel Medical Center
Clinical evaluation of a new cardiovascular oriented CT scanner from Arineta Ltd.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a clinical indication for cardiac CT

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Other: Cardiac CT scanning (with the SpotLight CT)
Cardiac CT scanning

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.
Time Frame: 2 years
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.
Time Frame: 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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of the new SpotLight CT scanner from Arineta Ltd.
Time Frame: 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.
2 years
The effect of cardiac CT results (with SpotLight CT) on patients triage
Time Frame: 5 years
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
Time Frame: 5 years
Predictive value of cardiac CT results for adverse outcomes (death/myocardial infarction/revascularization).
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Collaborators

Arineta Ltd.

Investigators

  • Principal Investigator: Ronen Rubinshtein, MD, Carmel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

November 23, 2015

First Submitted That Met QC Criteria

November 25, 2015

First Posted (Estimate)

November 30, 2015

Study Record Updates

Last Update Posted (Estimate)

March 24, 2016

Last Update Submitted That Met QC Criteria

March 23, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC-14-0127-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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