Carotid AtherosclerosisQ-CAMPNCT02143102
Non-invasive Computer-Aided Phenotyping of Vasculopathy
An observational study of Carotid Atherosclerosis and Peripheral Arterial Disease, run by Elucid Bioimaging Inc. at 2 sites in United States.
Trial summary
The investigators use MRI and/or CT to evaluate the extent, as well as, the structure, composition, and functional aspects of atherosclerotic plaques in human carotid and femoral arteries in patients scheduled to undergo an endarterectomy of the aforementioned vascular beds as part of their routine clinical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Atherosclerosis, Peripheral Arterial Disease
- How many people
- 125 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to 30 Jun 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Individuals must meet one of the following inclusion criteria in order to be eligible to participate in the study: * Case subjects will be patients with documented carotid atherosclerosis, scheduled for magnetic resonance or CT angiography and subsequent elective endarterectomy with 30 days of enrollment in the study * Case subjects will be patients with peripheral arterial disease (PAD) with clinical symptoms, scheduled for magnetic resonance or CT angiography and indicated endarterectomy of diseased areas of femoral arteries within 30 days of enrollment in the study
Who may be able to join
- Individuals must meet one of the following inclusion criteria in order to be eligible to participate in the study:
- Case subjects will be patients with documented carotid atherosclerosis, scheduled for magnetic resonance or CT angiography and subsequent elective endarterectomy with 30 days of enrollment in the study
- Case subjects will be patients with peripheral arterial disease (PAD) with clinical symptoms, scheduled for magnetic resonance or CT angiography and indicated endarterectomy of diseased areas of femoral arteries within 30 days of enrollment in the study
Who cannot join
- Subjects with claustrophobia or inability to tolerate prior MRI studies.
- Subjects with metal implants that are not MRI compatible (LSU detailed checklist to be attached) including: Subjects with any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.). Subjects with any type of ferromagnetic bio-implant that could potentially be displaced or damaged, such as aneurysm clips, metallic skull plates, etc.
- Subjects with a history of kidney disease or dialysis that are unable to receive intravenous gadolinium contrast material.
- Female subjects. A urine pregnancy test will be required of all female subjects of childbearing potential prior to inclusion in this study. Pregnant or nursing females will be excluded from the study.
- Subjects who cannot adhere to the experimental protocol.
- Subjects allergic to contrast material.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
West Jefferson Medical Center
Marrero, Louisiana, 70072
LSU ILH
New Orleans, Louisiana, 70112
About this study
Official title: vascuCAP: Non-invasive Computer-Aided Phenotyping of Vasculopathy
The investigators use MRI and/or CT to evaluate the extent, as well as, the structure, composition, and functional aspects of atherosclerotic plaques in human carotid and femoral arteries in patients scheduled to undergo an endarterectomy of the aforementioned vascular beds as part of their routine clinical care.
Read the detailed description
The investigators hypothesize that in vivo MRI and/or CT examinations of patients, when suitably acquired and analyzed with the vascuCAP™ analysis software, can provide a sufficiently accurate profile of plaque characteristics to provide an objective basis for patient management. Study subjects include patients undergoing endarterectomies to mitigate their clinical risk or symptoms for conditions including stroke, claudication, and critical limb ischemia. The endarterectomy specimens removed at surgery will allow a direct comparison between the MRI information obtained prior to the surgery and the histopathological analyses of the arterial specimens. The vascuCAP™ measurements of structural and functional features of the arterial wall will be performed in patients undergoing endarterectomy. Measured results will be compared in a blinded fashion with histology to assess performance of plaque profiling and build a pilot prediction model for risk scoring.
- Medical subject headings
- Carotid Artery Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Training set | Data from subjects in the training set will be utilized to further develop the vascuCAPTM classifiers. | |
| Testing set | Data from subjects in the testing set will be used to assess the study endpoints. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement Bias of Calcification Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.
Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)
Measured: Assessed on tissue samples collected within 30 days of non-invasive imaging
Measurement Bias of Lipid-rich Necrotic Core Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.
Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)
Measured: Assessed on tissue samples collected within 30 days of non-invasive imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startJul 2014
- Primary completion14 Mar 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid AtherosclerosisStudies 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
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elucid Bioimaging Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew J. Buckler, M.S., Study director, Elucid Biomaging Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143102
- Sponsor's protocol ID
- 305
- Acronym
- Q-CAMP
- Status last verified
- Nov 2017
- First submitted
- 15 May 2014
- Last updated
- 6 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sheahan M, Ma X, Paik D, Obuchowski NA, St Pierre S, Newman WP 3rd, Rae G, Perlman ES, Rosol M, Keith JC Jr, Buckler AJ. Atherosclerotic Plaque Tissue: Noninvasive Quantitative Assessment of Characteristics with Software-aided Measurements from Conventional CT Angiography. Radiology. 2018 Feb;286(2):622-631. doi: 10.1148/radiol.2017170127. Epub 2017 Aug 31.
PubMed 28858564
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- vascuCAP: Non-invasive Computer-Aided Phenotyping of Vasculopathy
- ClinicalTrials.gov ID
- NCT02143102
- Acronym / sponsor ID
- Q-CAMP / 305
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Elucid Bioimaging Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- 14 Mar 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Posted 6 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators use MRI and/or CT to evaluate the extent, as well as, the structure, composition, and functional aspects of atherosclerotic plaques in human carotid and femoral arteries in patients scheduled to undergo an endarterectomy of the aforementioned vascular beds as part of their routine clinical care.
Detailed description
The investigators hypothesize that in vivo MRI and/or CT examinations of patients, when suitably acquired and analyzed with the vascuCAP™ analysis software, can provide a sufficiently accurate profile of plaque characteristics to provide an objective basis for patient management. Study subjects include patients undergoing endarterectomies to mitigate their clinical risk or symptoms for conditions including stroke, claudication, and critical limb ischemia. The endarterectomy specimens removed at surgery will allow a direct comparison between the MRI information obtained prior to the surgery and the histopathological analyses of the arterial specimens. The vascuCAP™ measurements of structural and functional features of the arterial wall will be performed in patients undergoing endarterectomy. Measured results will be compared in a blinded fashion with histology to assess performance of plaque profiling and build a pilot prediction model for risk scoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training set | – | –Data from subjects in the training set will be utilized to further develop the vascuCAPTM classifiers. |
| Testing set | – | –Data from subjects in the testing set will be used to assess the study endpoints. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals must meet one of the following inclusion criteria in order to be eligible to participate in the study: * Case subjects will be patients with documented carotid atherosclerosis, scheduled for magnetic resonance or CT angiography and subsequent elective endarterectomy with 30 days of enrollment in the study * Case subjects will be patients with peripheral arterial disease (PAD) with clinical symptoms, scheduled for magnetic resonance or CT angiography and indicated endarterectomy of diseased areas of femoral arteries within 30 days of enrollment in the study
Key inclusion criteria (3 listed)
- Individuals must meet one of the following inclusion criteria in order to be eligible to participate in the study:
- Case subjects will be patients with documented carotid atherosclerosis, scheduled for magnetic resonance or CT angiography and subsequent elective endarterectomy with 30 days of enrollment in the study
- Case subjects will be patients with peripheral arterial disease (PAD) with clinical symptoms, scheduled for magnetic resonance or CT angiography and indicated endarterectomy of diseased areas of femoral arteries within 30 days of enrollment in the study
Key exclusion criteria (6 listed)
- Subjects with claustrophobia or inability to tolerate prior MRI studies.
- Subjects with metal implants that are not MRI compatible (LSU detailed checklist to be attached) including: Subjects with any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.). Subjects with any type of ferromagnetic bio-implant that could potentially be displaced or damaged, such as aneurysm clips, metallic skull plates, etc.
- Subjects with a history of kidney disease or dialysis that are unable to receive intravenous gadolinium contrast material.
- Female subjects. A urine pregnancy test will be required of all female subjects of childbearing potential prior to inclusion in this study. Pregnant or nursing females will be excluded from the study.
- Subjects who cannot adhere to the experimental protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement Bias of Calcification Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.
Time frame: Assessed on tissue samples collected within 30 days of non-invasive imaging
Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)
Measurement Bias of Lipid-rich Necrotic Core Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.
Time frame: Assessed on tissue samples collected within 30 days of non-invasive imaging
Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28858564Sheahan M, Ma X, Paik D, Obuchowski NA, St Pierre S, Newman WP 3rd, Rae G, Perlman ES, Rosol M, Keith JC Jr, Buckler AJ. Atherosclerotic Plaque Tissue: Noninvasive Quantitative Assessment of Characteristics with Software-aided Measurements from Conventional CT Angiography. Radiology. 2018 Feb;286(2):622-631. doi: 10.1148/radiol.2017170127. Epub 2017 Aug 31.
- 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.
Andrew J. Buckler, M.S. study director
Elucid Biomaging Inc.
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 Carotid Atherosclerosis and Peripheral Arterial Disease, run by Elucid Bioimaging Inc. 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 3 inclusion and 6 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 6 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 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?
Yes. Results are posted in the registry (first posted 6 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measurement Bias of Calcification Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth. (time frame: Assessed on tissue samples collected within 30 days of non-invasive imaging). 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 NCT02143102, 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 6 Aug 2018.