Vascular DiseasesHD-FFRctNCT05524896
Elucidate Vasodilatory Capacity From Histology-Defined Analysis of Coronary CT Angiography
An observational study of Vascular Diseases, run by Elucid Bioimaging Inc..
Trial summary
Coronary CT Angiography (CCTA) may be an ideal modality to fill gaps in understanding the extent and rate of progression coronary artery disease. The investigators have developed an image analysis software ElucidVivo that estimates relevant indices, including fractional flow reserve (FFR) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- ElucidVivo
- Type of treatment
- Medical device
- How many people
- 302 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 13 Jul 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 years and older
- All sexes
- Adult, Older adult
Study population: Subjects for which a CCTA had been taken within 60 days of invasive coronary angiography with FFR measurements.
Who may be able to join
- Subject must have successfully completed at least one (possibly multiple) CCTA for known or suspected coronary artery disease.
- CCTA was no more than 60 days earlier (and not later)
Who cannot join
- Subject has a history of percutaneous coronary intervention (PCI) with stent implantation and/or coronary artery bypass grafting (CABG)
- Subject with insufficient CCTA image quality (defined strictly as documented in the ElucidVivo Reading Manual)
About this study
Coronary CT Angiography (CCTA) may be an ideal modality to fill gaps in understanding the extent and rate of progression coronary artery disease. The investigators have developed an image analysis software ElucidVivo that estimates relevant indices, including fractional flow reserve (FFR) . In this study, the investigators aim to assess the value of ElucidVivo-based plaque morphology characterization for predicting non-invasive FFR in patients with suspected coronary artery disease (CAD) who had undergone clinically indicated coronary CTA and invasive coronary angiography (ICA) for physical FFR measurement.
Read the detailed description
Invasive FFR is a clinically validated measure of lesion-specific ischemia and is preferred over visual estimation of diameter stenosis for clinical decisions regarding coronary revascularization. FFR derived from coronary CTA (FFRct) using computational fluid dynamics (CFD)-based software has been shown to be a reasonably accurate estimate of invasive FFR and is included in contemporary guidelines as a decision-tool for management of patients with intermediate stenosis on coronary CTA. However, other methods have limitations. It is understood that the burden and type of coronary atherosclerosis, in addition to lumen stenosis, significantly impacts the vasodilatory capacity of the vessel walls which may provide a more interpretable analysis and broader clinical acceptance.
- Conditions
- Vascular Diseases
- Being tested
- ElucidVivo
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElucidVivoDevice
Plaque morphology characterization for predicting non-invasive fractional flow reserve (FFR)
| Study group | Role | What they receive |
|---|---|---|
| Low FFR | Invasive FFR value <= 0.8 Receives: Device: ElucidVivo | |
| High FFR | Invasive FFR value > 0.8 Receives: Device: ElucidVivo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
the ability of a test to correctly identify patients with low FFR
Measured: 1 day
Specificity
the ability of a test to correctly identify people without low FFR
Measured: 1 day
Secondary outcomes (1)
Average Error
Difference of noninvasive result - invasive result
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start1 Jan 2017
- Primary completion31 May 2021
- Study completion13 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseasesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elucid Bioimaging Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. Francis Medical Center, New Jersey, The Christ Hospital, Medical University of South Carolina, Mie University
- Responsible party
- Sponsor
- Investigators
- Andrew J Buckler, Principal investigator, Elucid Bioimaging Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524896
- Sponsor's protocol ID
- HD-FFRct
- Acronym
- HD-FFRct
- Status last verified
- Sep 2022
- First submitted
- 30 Aug 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We will not share IPD
Publications
Varga-Szemes A, Schoepf UJ, Maurovich-Horvat P, Wang R, Xu L, Dargis DM, Emrich T, Buckler AJ. Coronary plaque assessment of Vasodilative capacity by CT angiography effectively estimates fractional flow reserve. Int J Cardiol. 2021 May 15;331:307-315. doi: 10.1016/j.ijcard.2021.01.040. Epub 2021 Jan 30.
PubMed 33529657
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidate Vasodilatory Capacity From Histology-Defined Analysis of Coronary CT Angiography
- ClinicalTrials.gov ID
- NCT05524896
- Acronym / sponsor ID
- HD-FFRct / HD-FFRct
- Conditions
- Vascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Elucid Bioimaging Inc.Industry (pharma, biotech, devices)
- Collaborators
- St. Francis Medical Center, New Jersey, The Christ Hospital, Medical University of South Carolina, Mie University
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 1 Sep 2022 (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.
Coronary CT Angiography (CCTA) may be an ideal modality to fill gaps in understanding the extent and rate of progression coronary artery disease. The investigators have developed an image analysis software ElucidVivo that estimates relevant indices, including fractional flow reserve (FFR) . In this study, the investigators aim to assess the value of ElucidVivo-based plaque morphology characterization for predicting non-invasive FFR in patients with suspected coronary artery disease (CAD) who had undergone clinically indicated coronary CTA and invasive coronary angiography (ICA) for physical FFR measurement.
Detailed description
Invasive FFR is a clinically validated measure of lesion-specific ischemia and is preferred over visual estimation of diameter stenosis for clinical decisions regarding coronary revascularization. FFR derived from coronary CTA (FFRct) using computational fluid dynamics (CFD)-based software has been shown to be a reasonably accurate estimate of invasive FFR and is included in contemporary guidelines as a decision-tool for management of patients with intermediate stenosis on coronary CTA. However, other methods have limitations. It is understood that the burden and type of coronary atherosclerosis, in addition to lumen stenosis, significantly impacts the vasodilatory capacity of the vessel walls which may provide a more interpretable analysis and broader clinical acceptance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low FFR | – | Device: ElucidVivoInvasive FFR value <= 0.8 |
| High FFR | – | Device: ElucidVivoInvasive FFR value > 0.8 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects for which a CCTA had been taken within 60 days of invasive coronary angiography with FFR measurements.
Key inclusion criteria (2 listed)
- Subject must have successfully completed at least one (possibly multiple) CCTA for known or suspected coronary artery disease.
- CCTA was no more than 60 days earlier (and not later)
Key exclusion criteria (2 listed)
- Subject has a history of percutaneous coronary intervention (PCI) with stent implantation and/or coronary artery bypass grafting (CABG)
- Subject with insufficient CCTA image quality (defined strictly as documented in the ElucidVivo Reading Manual)
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 |
|---|---|---|
| ElucidVivoPlaque morphology characterization for predicting non-invasive fractional flow reserve (FFR) | Device | High FFR, Low FFR |
Primary outcome
Sensitivity
Time frame: 1 day
the ability of a test to correctly identify patients with low FFR
Specificity
Time frame: 1 day
the ability of a test to correctly identify people without low FFR
1 secondary outcome
Average Error
Time frame: 1 day
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 8 Sep 2022.
- Background: PubMed 33529657Varga-Szemes A, Schoepf UJ, Maurovich-Horvat P, Wang R, Xu L, Dargis DM, Emrich T, Buckler AJ. Coronary plaque assessment of Vasodilative capacity by CT angiography effectively estimates fractional flow reserve. Int J Cardiol. 2021 May 15;331:307-315. doi: 10.1016/j.ijcard.2021.01.040. Epub 2021 Jan 30.
- Individual participant dataSharing planned: No. We will not share IPD
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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.
Andrew J Buckler principal investigator
Elucid Bioimaging Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Diseases, run by Elucid Bioimaging Inc..
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 2 inclusion and 2 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 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Sensitivity (time frame: 1 day). 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?
On the ClinicalTrials.gov record for NCT05524896, which also lists 1 linked publication.
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 8 Sep 2022.