Cardiovascular DiseasesNCT05171764
Dual Energy Cardiac CT Data Collection and Evaluation
An observational study of Cardiovascular Diseases, run by GE Healthcare at 1 site in Switzerland.
Trial summary
This study is intended to collect clinical feasibility data using this prototype research mode for the purposes of understanding potential clinical impact, potential limitations and strengths, and to further develop the technique through development of image reconstruction and processing approaches or identification… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Additional Gemstone Spectral Imaging (GSI) cardiac scan
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Nov 2022to 13 Oct 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be enrolled that will be undergoing a routine cardiac CT imaging scan. Subjects will be representative of the general population expected to undergo cardiac CT imaging as standard of care clinical practice.
Who may be able to join
- Patients > 50 years old undergoing routine cardiac CT imaging exam;
- Patients that within last 12 months did not undergo medical procedures involving ionizing radiation;
- Signed informed consent.
Who cannot join
- Contradictions to contrast;
- Contraindications for beta blocker;
- BMI >30;
- High heart rate ≥75 BPM;
- Atrial Fibrillation;
- Arrythmia or irregular heartbeats;
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- Pregnant women;
- Patients lacking capacity in providing informed consent
- Patients who did participate in prior research studies with ionizing radiation in the last 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Data Collection of Dual Energy Cardiac CT on a Wide Coverage System
This study is intended to collect clinical feasibility data using this prototype research mode for the purposes of understanding potential clinical impact, potential limitations and strengths, and to further develop the technique through development of image reconstruction and processing approaches or identification of other areas of development required.
Read the detailed description
Up to 38 subjects may be enrolled to achieve the target number of 30 evaluable subjects. Withdrawn or discontinued subjects who are enrolled and received the investigational scan, may be replaced. Subject participation will be deemed complete once the diagnostic and investigational scans are completed. A subject is considered evaluable when images and raw data from the diagnostic single energy cardiac CT scan and raw data from the investigational dual energy cardiac CT scan have been collected successfully and demonstrate a diagnostic interpretation.
- Conditions
- Cardiovascular Diseases
- Being tested
- Additional Gemstone Spectral Imaging (GSI) cardiac scan
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional Gemstone Spectral Imaging (GSI) cardiac scanDevice
After the subject undergoes the clinically prescribed cardiac Computed Tomography (CT) scan for their diagnostic purposes, the investigational Gemstone Spectral Imaging (GSI) scan will be conducted following the diagnostic CT scan utilizing the same contrast administration.
| Study group | Role | What they receive |
|---|---|---|
| Coronary CTA | After the subject undergoes the standard of care, clinically indicated cardiac CT scan for diagnostic purposes, the investigational scan using the GSI Cardiac Scan Mode will be conducted utilizing the same contrast administration. Receives: Device: Additional Gemstone Spectral Imaging (GSI) cardiac scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect Data
Data will be collected from the scanner for future post-processing and engineering development. There is no analysis planned at this time for the data, simply data collection.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Evaluation- Likert Scale
Complete an image evaluation using a 5 point Likert Scale (1 - Non-Diagnostic to 5 - Excellent Image Quality), done by a qualified cardiac imaging expert.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start14 Nov 2022
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Zürich
- Responsible party
- Sponsor
- Investigators
- Melissa Challman, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171764
- Sponsor's protocol ID
- 219693723
- Status last verified
- Dec 2023
- First submitted
- 25 Nov 2021
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Data Collection of Dual Energy Cardiac CT on a Wide Coverage System
- ClinicalTrials.gov ID
- NCT05171764
- Acronym / sponsor ID
- 219693723
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Zürich
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 29 Dec 2021 (actual)
- 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.
This study is intended to collect clinical feasibility data using this prototype research mode for the purposes of understanding potential clinical impact, potential limitations and strengths, and to further develop the technique through development of image reconstruction and processing approaches or identification of other areas of development required.
Detailed description
Up to 38 subjects may be enrolled to achieve the target number of 30 evaluable subjects. Withdrawn or discontinued subjects who are enrolled and received the investigational scan, may be replaced. Subject participation will be deemed complete once the diagnostic and investigational scans are completed. A subject is considered evaluable when images and raw data from the diagnostic single energy cardiac CT scan and raw data from the investigational dual energy cardiac CT scan have been collected successfully and demonstrate a diagnostic interpretation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary CTA | – | Device: Additional Gemstone Spectral Imaging (GSI) cardiac scanAfter the subject undergoes the standard of care, clinically indicated cardiac CT scan for diagnostic purposes, the investigational scan using the GSI Cardiac Scan Mode will be conducted utilizing the same contrast administration. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be enrolled that will be undergoing a routine cardiac CT imaging scan. Subjects will be representative of the general population expected to undergo cardiac CT imaging as standard of care clinical practice.
Key inclusion criteria (3 listed)
- Patients > 50 years old undergoing routine cardiac CT imaging exam;
- Patients that within last 12 months did not undergo medical procedures involving ionizing radiation;
- Signed informed consent.
Key exclusion criteria (9 listed)
- Contradictions to contrast;
- Contraindications for beta blocker;
- BMI >30;
- High heart rate ≥75 BPM;
- Atrial Fibrillation;
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 |
|---|---|---|
| Additional Gemstone Spectral Imaging (GSI) cardiac scanAfter the subject undergoes the clinically prescribed cardiac Computed Tomography (CT) scan for their diagnostic purposes, the investigational Gemstone Spectral Imaging (GSI) scan will be conducted following the diagnostic CT scan utilizing the same contrast administration. | Device | Coronary CTA |
Primary outcome
Collect Data
Time frame: through study completion, an average of 1 year
Data will be collected from the scanner for future post-processing and engineering development. There is no analysis planned at this time for the data, simply data collection.
1 secondary outcome
Evaluation- Likert Scale
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
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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.
Melissa Challman study director
GE Healthcare
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 Cardiovascular Diseases, run by GE Healthcare at 1 site in Switzerland.
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 9 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: finished, as of the sponsor's last update on 18 Dec 2023. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect Data (time frame: through study completion, an average of 1 year). 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 18 Dec 2023.