Radiation Dose ReductionNCT02855528
Tin Filter Calcium Scoring
A study testing Tin Filter in people with Radiation Dose Reduction, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The aim of this study is to prospectively investigate the diagnostic performance and potential radiation dose reduction in coronary artery calcium scoring using the new tin filter system of the 3rd generation DSCT scanner. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Radiation Dose Reduction
- What is being tested?
- Tin Filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 14 Nov 2017
- Phase
- Interventional
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be between 19-90 years of age.
- Subject must have been referred for a clinically indicated coronary artery calcium scan and/or coronary CT angiography or TRO scan with coronary artery calcium scoring.
- Subject must provide written informed consent prior to any study-related procedures being performed.
- Subject must be willing to comply with all clinical study procedures.
Who cannot join
- Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
- By testing (urine BHCG) within 24 hours before scan, or
- By surgical sterilization, or
- Post menopausal, with minimum one (1) year history without menses.
- Subject has an acute psychiatric disorder or is cognitively impaired.
- Subject is using or is dependent on substances of abuse.
- Subject is unwilling to comply with the requirements of the protocol.
- Subject is in acute unstable condition.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Ultra Low-dose Coronary Artery Calcium Scoring Using Tin Filtration With Dual-source CT
The aim of this study is to prospectively investigate the diagnostic performance and potential radiation dose reduction in coronary artery calcium scoring using the new tin filter system of the 3rd generation DSCT scanner.
- Conditions
- Radiation Dose Reduction
- Being tested
- Tin Filter
- Keywords
- Tin Filter, Coronary Artery Calcium Scoring, Radiation dose reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tin FilterDevice
| Study group | Role | What they receive |
|---|---|---|
| Reduction of radiation dose and diagnostic accuracy | Experimental | Reduction of radiation dose during coronary artery calcium scoring with the use of a tin filter system. Receives: Device: Tin Filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in radiation dose using the new tin-filter system
Measured: 2 years
Diagnostic accuracy of novel ultralow-dose non-enhanced coronary artery calcium scoring performed with the new tin filter system.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startDec 2015
- Primary completion14 Nov 2017
- Study completion14 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation Dose ReductionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph U. Schoepf, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855528
- Sponsor's protocol ID
- Pro00051523
- Status last verified
- Mar 2018
- First submitted
- 28 Jul 2016
- Last updated
- 2 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra Low-dose Coronary Artery Calcium Scoring Using Tin Filtration With Dual-source CT
- ClinicalTrials.gov ID
- NCT02855528
- Acronym / sponsor ID
- Pro00051523
- Conditions
- Radiation Dose Reduction
- Keywords
- Tin Filter, Coronary Artery Calcium Scoring, Radiation dose reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 14 Nov 2017 (actual)
- Study completion
- 14 Nov 2017 (actual)
- First posted
- 4 Aug 2016 (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.
The aim of this study is to prospectively investigate the diagnostic performance and potential radiation dose reduction in coronary artery calcium scoring using the new tin filter system of the 3rd generation DSCT scanner.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reduction of radiation dose and diagnostic accuracy | Experimental | Device: Tin FilterReduction of radiation dose during coronary artery calcium scoring with the use of a tin filter system. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must be between 19-90 years of age.
- Subject must have been referred for a clinically indicated coronary artery calcium scan and/or coronary CT angiography or TRO scan with coronary artery calcium scoring.
- Subject must provide written informed consent prior to any study-related procedures being performed.
- Subject must be willing to comply with all clinical study procedures.
Key exclusion criteria (8 listed)
- Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
- By testing (urine BHCG) within 24 hours before scan, or
- By surgical sterilization, or
- Post menopausal, with minimum one (1) year history without menses.
- Subject has an acute psychiatric disorder or is cognitively impaired.
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 |
|---|---|---|
| Tin Filter | Device | Reduction of radiation dose and diagnostic accuracy |
Primary outcome
Reduction in radiation dose using the new tin-filter system
Time frame: 2 years
Diagnostic accuracy of novel ultralow-dose non-enhanced coronary artery calcium scoring performed with the new tin filter system.
Time frame: 2 years
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 2 Aug 2018.
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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.
Joseph U. Schoepf, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tin Filter in people with Radiation Dose Reduction, run by Medical University of South Carolina at 1 site 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 8 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 2 Aug 2018. 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 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?
Reduction in radiation dose using the new tin-filter system (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 2 Aug 2018.