Atherosclerotic PlaqueNCT04267094
Reduced Radiation Dose and IR-impact on Coronary Calcium Quantification
A study testing Iterative reconstruction at reduced radiation dose in people with Atherosclerotic Plaque, run by University of Pennsylvania at 1 site in United States.
Trial summary
Evaluation of reduced radiation dose iterative reconstruction reconstructions for calcium scoring compared to full dose filtered back projection reconstructions Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atherosclerotic Plaque
- What is being tested?
- Iterative reconstruction at reduced radiation dose
- Type of treatment
- Medical device
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 7 Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing routine calcium scoring CT at facilities at the University of Pennsylvania
Who cannot join
- Patients found to have no coronary calcium on full dose FBP reconstructions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Single-center, Multi-scanner, Observational Study to Investigate the Impact of Reduced Radiation Dose and Iterative Reconstruction Algorithms on Coronary Calcium Score in Comparison to the Standard Normal Radiation Dose -Filtered Back Projection Method
Evaluation of reduced radiation dose iterative reconstruction reconstructions for calcium scoring compared to full dose filtered back projection reconstructions
- Conditions
- Atherosclerotic Plaque
- Being tested
- Iterative reconstruction at reduced radiation dose
- Medical subject headings
- Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iterative reconstruction at reduced radiation doseDevice
Evaluating Agatston coronary calcium score using reduced dose acquisitions reconstructed using iterative reconstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium score
Calcium score compared to FBP full dose recon
Measured: immediate
Secondary outcomes (1)
Risk stratification
Cardiovascular risk stratification group of reduced dose IR vs. full dose FBP
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Jul 2017
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Why it stopped: Science has changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic PlaqueStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harold Litt, MD, PhD, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267094
- Sponsor's protocol ID
- 824735
- Status last verified
- Mar 2024
- First submitted
- 10 Feb 2020
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Multi-scanner, Observational Study to Investigate the Impact of Reduced Radiation Dose and Iterative Reconstruction Algorithms on Coronary Calcium Score in Comparison to the Standard Normal Radiation Dose -Filtered Back Projection Method
- ClinicalTrials.gov ID
- NCT04267094
- Acronym / sponsor ID
- 824735
- Conditions
- Atherosclerotic Plaque
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Science has changed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 12 Feb 2020 (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.
Evaluation of reduced radiation dose iterative reconstruction reconstructions for calcium scoring compared to full dose filtered back projection reconstructions
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing routine calcium scoring CT at facilities at the University of Pennsylvania
Key exclusion criteria (1 listed)
- Patients found to have no coronary calcium on full dose FBP reconstructions
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 |
|---|---|---|
| Iterative reconstruction at reduced radiation doseEvaluating Agatston coronary calcium score using reduced dose acquisitions reconstructed using iterative reconstruction | Device | – |
Primary outcome
Calcium score
Time frame: immediate
Calcium score compared to FBP full dose recon
1 secondary outcome
Risk stratification
Time frame: immediate
Results and safety
The study was stopped early (reason given: Science has changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
Related trials for Atherosclerotic Plaque
RecruitingPhase 3
A Study to See if Lepodisiran Can Reduce Plaque in Coronary Arteries of Adults With Elevated Lp(a) Who Have Had Heart Events or Are at High Risk
Atherosclerosis, Cardiovascular Diseases
RecruitingObservational study
Coronary Myocardial Bridge and Coronary Plaques on MDCT
Myocardial Bridging, Coronary Atherosclerosis
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
Active, not recruitingPhase 4
Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Not yet recruiting
PREventive Invasive Strategy for Obstructive Coronary Artery Disease With Vulnerable Plaque Evaluated by CoroNary Computed Tomography Angiography-2
Coronary Artery Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iterative reconstruction at reduced radiation dose in people with Atherosclerotic Plaque, run by University of Pennsylvania 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 7 Mar 2024. 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 was stopped early (reason given: Science has changed). Results are not available in the source record.
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?
Calcium score (time frame: immediate). 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 Mar 2024.