Cardiac CTNCT05949138
Clinical Data Collection and Evaluation of ECG-Less Cardiac CT
An observational study of Cardiac CT, run by GE Healthcare at 2 sites in United States.
Trial summary
The primary objective of this study is to collect CT scan data without ECG-leads attached to the human subject. This data is intended to represent a typical range of clinical scenarios in which Cardiac CT imaging is used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac CT
- What is being tested?
- ECG-Less Cardiac CT using SmartPhase
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Sep 2023to 3 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subject population will consist of adults that are 18-years of age or older, and who are scheduled for a clinically indicated cardiac CT exam that will include contrast administration.
Who may be able to join
- Subjects may be included in this study if they meet the following criteria:
- Who are 18 year of age or older;
- Able to sign and date the informed consent form; AND
- Who are scheduled for a clinical-indicated Cardiac CT exam that will include contrast administration.
Who cannot join
- Subjects may be excluded from participating in study if they meet any of the following criteria:
- Who are pregnant or lactating;
- Who were previously enrolled in this study;
- Anyone with known or suspected allergy to iodinated contrast agents;
- Anyone with known or suspected renal insufficiency as determined by site medical personnel;
- Who are scheduled for a CT cardiac calcium scoring test;
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- Who are in need of urgent or emergent care;
- Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; AND
- Who are unwilling to have GEHC personnel present for the CT exam.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Chicago
Chicago, Illinois, 60637
University of Washington
Seattle, Washington, 98195
About this study
The primary objective of this study is to collect CT scan data without ECG-leads attached to the human subject. This data is intended to represent a typical range of clinical scenarios in which Cardiac CT imaging is used.
Read the detailed description
Data collected in this study will be used for technology development, scientific evaluation, marketing and education, and regulatory submissions for future products. This is a pre-market, prospective, open-label, non-randomized, single arm data collection clinical study conducted at one site in the United States of America.
- Conditions
- Cardiac CT
- Being tested
- ECG-Less Cardiac CT using SmartPhase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG-Less Cardiac CT using SmartPhaseDevice
Administration of medications and biologic products (such as contrast agent administration, and potentially beta-blockers and other medications) will be given according to standard hospital care.
This is a prospective research study evaluating an investigational workflow on an existing CT device that has regulatory clearance. The investigational workflow includes preforming the CT acquisition according to the hospital's usual care with the exception that the ECG signal which triggers the scan will be coming from an ECG simulator based on an estimate of the patient's heart rate, rather than through ECG leads connected to the subject. Clinically-indicated Cardiac CTs take approximately 30-60 minutes. No additional imaging is needed as part of the study.
| Study group | Role | What they receive |
|---|---|---|
| ECG-Less Cardiac CT | Enrolled subjects will receive a clinically-indicated, diagnostic Cardiac CT with contrast. No ECG leads will be applied. Receives: Device: ECG-Less Cardiac CT using SmartPhase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Collection
Number of Participants with raw investigational cardiac CT scan data
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start11 Sep 2023
- Primary completion1 Nov 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac CTStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Chicago, University of Washington
- Responsible party
- Sponsor
- Investigators
- Kayla Matcheck, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949138
- Sponsor's protocol ID
- 11771729874
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2023
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Data Collection and Evaluation of ECG-Less Cardiac CT
- ClinicalTrials.gov ID
- NCT05949138
- Acronym / sponsor ID
- 11771729874
- Conditions
- Cardiac CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- University of Chicago, University of Washington
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 17 Jul 2023 (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.
The primary objective of this study is to collect CT scan data without ECG-leads attached to the human subject. This data is intended to represent a typical range of clinical scenarios in which Cardiac CT imaging is used.
Detailed description
Data collected in this study will be used for technology development, scientific evaluation, marketing and education, and regulatory submissions for future products. This is a pre-market, prospective, open-label, non-randomized, single arm data collection clinical study conducted at one site in the United States of America.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECG-Less Cardiac CT | – | Device: ECG-Less Cardiac CT using SmartPhaseEnrolled subjects will receive a clinically-indicated, diagnostic Cardiac CT with contrast. No ECG leads will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population will consist of adults that are 18-years of age or older, and who are scheduled for a clinically indicated cardiac CT exam that will include contrast administration.
Key inclusion criteria (4 listed)
- Who are 18 year of age or older;
- Able to sign and date the informed consent form; AND
- Who are scheduled for a clinical-indicated Cardiac CT exam that will include contrast administration.
Key exclusion criteria (9 listed)
- Subjects may be excluded from participating in study if they meet any of the following criteria:
- Who are pregnant or lactating;
- Who were previously enrolled in this study;
- Anyone with known or suspected allergy to iodinated contrast agents;
- Anyone with known or suspected renal insufficiency as determined by site medical personnel;
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 |
|---|---|---|
| ECG-Less Cardiac CT using SmartPhaseAdministration of medications and biologic products (such as contrast agent administration, and potentially beta-blockers and other medications) will be given according to standard hospital care. This is a prospective research study evaluating an investigational workflow on an existing CT device that has regulatory clearance. The investigational workflow includes preforming the CT acquisition according to the hospital's usual care with the exception that the ECG signal which triggers the scan will be coming from an ECG simulator based on an estimate of the patient's heart rate, rather than through ECG leads connected to the subject. Clinically-indicated Cardiac CTs take approximately 30-60 minutes. No additional imaging is needed as part of the study. | Device | ECG-Less Cardiac CT |
Primary outcome
Data Collection
Time frame: Through study completion, an average of 6 months
Number of Participants with raw investigational cardiac CT scan data
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 7 Jun 2024.
- 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.
Kayla Matcheck study director
GE Healthcare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac CT, run by GE Healthcare at 2 sites in United States.
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 4 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 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Data Collection (time frame: Through study completion, an average of 6 months). 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 7 Jun 2024.