Coronary Artery DiseaseArinetaNCT02616939
Clinical In-hospital Evaluation of the Usefulness of a New Multi-detector Computed Tomography Scanner From Arineta Ltd
An observational study of Coronary Artery Disease, run by Carmel Medical Center at 1 site in Israel.
Trial summary
Clinical evaluation of a new cardiovascular oriented CT scanner from Arineta Ltd. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cardiac CT scanning (with the SpotLight CT)
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2016to Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a clinical indication for cardiac CT
Who may be able to join
- Symptomatic patients with a clinical indication for cardiac CT
- Patients with a clinical indication for CT
- Estimated GFR > 60 mL/min
Who cannot join
- No clinical indication for CT scanning
- Contra-indication for CT scanning or for IV contrast administration
- Pregnancy
- Inability to give an informed consent
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Carmel Medical Center
Haifa, 34362
Ronen Rubinshtein, MD, ronenrub@clalit.org.il
Mali Aizencot, RN PHD, maliaz@clalit.org.il
About this study
Clinical evaluation of a new cardiovascular oriented CT scanner from Arineta Ltd.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Cardiac CT scanning (with the SpotLight CT)
- Keywords
- Multidetector computed tomography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CT scanning (with the SpotLight CT)Other
Cardiac CT scanning
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Cardiac CT scanning (with the SpotLight CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 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
Measured: 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).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionNov 2020 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Arineta Ltd.
- Responsible party
- Sponsor
- Investigators
- Ronen Rubinshtein, MD, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616939
- Sponsor's protocol ID
- CMC-14-0127-CTIL
- Acronym
- Arineta
- Status last verified
- Mar 2016
- First submitted
- 23 Nov 2015
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical In-hospital Evaluation of the Usefulness of a New Multi-detector Computed Tomography Scanner From Arineta Ltd
- ClinicalTrials.gov ID
- NCT02616939
- Acronym / sponsor ID
- Arineta / CMC-14-0127-CTIL
- Conditions
- Coronary Artery Disease
- Keywords
- Multidetector computed tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Collaborators
- Arineta Ltd.
- Study start
- Jan 2016
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 30 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected cardiac disease | – | Other: 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). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a clinical indication for cardiac CT
Key inclusion criteria (3 listed)
- Symptomatic patients with a clinical indication for cardiac CT
- Patients with a clinical indication for CT
- Estimated GFR > 60 mL/min
Key exclusion criteria (4 listed)
- No clinical indication for CT scanning
- Contra-indication for CT scanning or for IV contrast administration
- Pregnancy
- Inability to give an informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac CT scanning (with the SpotLight CT)Cardiac CT scanning | Other | Patients with suspected cardiac disease |
Primary outcome
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.
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.
3 secondary outcomes
Diagnostic accuracy of the new SpotLight CT scanner from Arineta Ltd.
Time frame: 2 years
The effect of cardiac CT results (with SpotLight CT) on patients triage
Time frame: 5 years
The predictive value of cardiac CT results (with SpotLight CT) for patients outcome
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronen Rubinshtein, MD principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronen Rubinshtein, MD (+972-4-8250153, ronenrub@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality (subjective) of the new SpotLight CT scanner from Arineta Ltd. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.