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

NCT ID: NCT02616939

Last Updated: 2016-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2022-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Cardiac CT scanning (with the SpotLight CT)

Intervention Type OTHER

Cardiac CT scanning

Interventions

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Cardiac CT scanning (with the SpotLight CT)

Cardiac CT scanning

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arineta Ltd.

INDUSTRY

Sponsor Role collaborator

Carmel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronen Rubinshtein, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Locations

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Carmel Medical Center

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ronen Rubinshtein, MD

Role: CONTACT

+972-4-8250153

Mali Azencot, PHD-RN

Role: CONTACT

+972-4-8250844

Facility Contacts

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Ronen Rubinshtein, MD

Role: primary

Mali Aizencot, RN PHD

Role: backup

Other Identifiers

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CMC-14-0127-CTIL

Identifier Type: -

Identifier Source: org_study_id

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