Vascular CalcificationCALCIFY2DNCT03839732
Observer Variability in Scoring Abdominal Aortic Calcifications and Vertebral Morphometry
An observational study of Vascular Calcification and Vertebral Fracture, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
BACKGROUND In the context of a progressively aging population, monitoring the status of Vascular Calcifications (VC) and Vertebral Fractures (VF) over time would be of primary importance, as VC and VF are recognized to be hallmarks of severe cardiovascular events (hospitalization and/or death) and hip fractures… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Vascular Calcification, Vertebral Fracture
- What is being tested?
- Score of abdominal aorta calcifications
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 28 Nov 2018to 27 Apr 2021
- 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 20 years and older
- All sexes
- Adult, Older adult
Study population: All patients that were included in a previous interventional trial of the sponsor institution aimed to compare the effectiveness of vertebroplastic and kyphoplastic augmentations of the throracolumbar spine. The choice of this population was driven by previous reports on similar populations stating a high prevalence of vascular calcifications.
Who may be able to join
- Patients included in a previous interventional study (VTP vs KYPHO) of the sponsor.
- Availability of diagnostic images (Dorso-lumbar radiographies taken in L-L projection).
- Rx images will be screened for the presence of VC, retaining only those showing VC.
- Informed consent obtained prior to any study analysis-evaluation.
Who cannot join
- Images showing severe artefacts (usually due to presence of metallic devices) that alter the grayscale range and hinder correct identification of VC and vertebral fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Calcify2D: Assessment of Observer Variability of a New Software for the Quantitative Evaluation of Abdominal Aortic Calcifications, Vertebral Morphometry and Their Relationships in Fragile Patients, Compared to Current Visual Scoring Methods
BACKGROUND In the context of a progressively aging population, monitoring the status of Vascular Calcifications (VC) and Vertebral Fractures (VF) over time would be of primary importance, as VC and VF are recognized to be hallmarks of severe cardiovascular events (hospitalization and/or death) and hip fractures respectively, and VF represent an under-diagnosed cause of progressive disability and pain on its own. Moreover, there is an acknowledged relationships between VC and VF.
However, data about the emergence/progression of VC and the emergence/worsening of VF over time are lacking. This is likely due to the absence of monitoring instruments for VC and VF that are both precise and easily accessible/applicable.
Read more
OBJECTIVE This study aims to define the observer variability of a new software developed by the study sponsor and collaborators, called Calcify2D. Calcify2D offers physicians a computer-assisted procedure to simultaneously score vascular calcifications at the abdominal aorta and lumbar vertebral fractures (according to Quantitative Vertebral Morphometry principles) based on a latero-lateral thoracolumbar spine radiography. Secondary aims are the validation of the scores obtained from latero-lateral thoracolumbar spine radiography with more invasive and/or costly gold-standard imaging modalities (Computed Tomography for VC, Magnetic Resonance for VF) that may have been acquired near-simultaneously to radiographs on the patients enrolled for the study.
STUDY DESIGN Not-for-profit monocentric observational study to be conducted on the diagnostic images of the thoracolumbar spine already collected at Istituto Ortopedico Rizzoli (IOR) within a previous interventional study.
Scoring of VC and VF will be performed by four clinicians from four relevant specialties, chosen among those who may often see VC and VF and are already familiar with the traditional scoring systems for both VC and VF (one radiologist and one spine orthopaedics from IOR, one nephrologist from the National Research Council and one internist from University of Padua).
Each clinician will assess all radiographs to score VC and QVM, both via computer assisted procedures and via traditional visual inspection. To avoid bias, an interval of at least one week will be left between the computer assisted and visual scoring. To define intra-observer variability (i.e. repeatability), the whole dataset will be re-assessed three times.
- Conditions
- Vascular Calcification, Vertebral Fracture
- Being tested
- Score of abdominal aorta calcifications
- Keywords
- observer variability, kauppila score, quantitative vertebral morphometry, computer assisted procedure, abdominal aorta, lumbar spine
- Medical subject headings
- Vascular Calcification, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Score of abdominal aorta calcificationsDiagnostic test
Also called Score of lumbar spine vertebral fractures
Radiographs showing VC will be used to assess whether the computer assisted VC scoring (primary objective) and Quantitative Vertebral Morphometry (QVM, limited to lumbar spine, secondary objective n.1) through the Calcify2D software are less variable with respect to the traditional visual scoring of VC and QVM.
| Study group | Role | What they receive |
|---|---|---|
| Vascular Calcification Group | Patients with prevalent vascular calcifications will be analysed to verify the intra- and inter-observer reliability of the score of abdominal aorta calcifications Receives: Diagnostic Test: Score of abdominal aorta calcifications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observer variability in scoring Vascular Calcification at the abdominal aorta
Observer variability (repeatability and reproducibility) in the assessment of vascular calcifications at the abdominal aorta according to a widely adopted scoring system (Kauppila et al., 1997): comparison between computer assisted and visual scoring.
Measured: through study completion, 1 year at maximum
Secondary outcomes (3)
Observer variability in scoring Vertebral Fractures at the lumbar spine
Observer variability (repeatability and reproducibility) in the assessment of vertebral fractures in the lumbar spine according to Quantitative Vertebral Morphometry (Genant et al., 2000): comparison between computer assisted and visual scoring.
Measured: through study completion, 1 year at maximum
Accuracy of computer assisted VC score
Accuracy of VC score computed by Calcify2D software will be tested against a gold standard CT-based score
Measured: through study completion, 1 year at maximum
Accuracy of computer assisted QVM
Accuracy of QVM score computed by Calcify2D software will be tested for the detection of mild vertebral fractures against gold standard Magnetic Resonance imaging
Measured: through study completion, 1 year at maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start28 Nov 2018
- Primary completion31 Oct 2019
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular CalcificationStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, University of Padova
- Responsible party
- Sponsor
- Investigators
- Enrico Schileo, Ph.D., Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839732
- Sponsor's protocol ID
- CE AVEC 695/2018/Oss/IOR
- Acronym
- CALCIFY2D
- Status last verified
- May 2023
- First submitted
- 8 Feb 2019
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcify2D: Assessment of Observer Variability of a New Software for the Quantitative Evaluation of Abdominal Aortic Calcifications, Vertebral Morphometry and Their Relationships in Fragile Patients, Compared to Current Visual Scoring Methods
- ClinicalTrials.gov ID
- NCT03839732
- Acronym / sponsor ID
- CALCIFY2D / CE AVEC 695/2018/Oss/IOR
- Conditions
- Vascular Calcification, Vertebral Fracture
- Keywords
- observer variability, kauppila score, quantitative vertebral morphometry, computer assisted procedure, abdominal aorta, lumbar spine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, University of Padova
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 15 Feb 2019 (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.
BACKGROUND In the context of a progressively aging population, monitoring the status of Vascular Calcifications (VC) and Vertebral Fractures (VF) over time would be of primary importance, as VC and VF are recognized to be hallmarks of severe cardiovascular events (hospitalization and/or death) and hip fractures respectively, and VF represent an under-diagnosed cause of progressive disability and pain on its own. Moreover, there is an acknowledged relationships between VC and VF.
However, data about the emergence/progression of VC and the emergence/worsening of VF over time are lacking. This is likely due to the absence of monitoring instruments for VC and VF that are both precise and easily accessible/applicable.
OBJECTIVE This study aims to define the observer variability of a new software developed by the study sponsor and collaborators, called Calcify2D. Calcify2D offers physicians a computer-assisted procedure to simultaneously score vascular calcifications at the abdominal aorta and lumbar vertebral fractures (according to Quantitative Vertebral Morphometry principles) based on a latero-lateral thoracolumbar spine radiography. Secondary aims are the validation of the scores obtained from latero-lateral thoracolumbar spine radiography with more invasive and/or costly gold-standard imaging modalities (Computed Tomography for VC, Magnetic Resonance for VF) that may have been acquired near-simultaneously to radiographs on the patients enrolled for the study.
STUDY DESIGN Not-for-profit monocentric observational study to be conducted on the diagnostic images of the thoracolumbar spine already collected at Istituto Ortopedico Rizzoli (IOR) within a previous interventional study.
Scoring of VC and VF will be performed by four clinicians from four relevant specialties, chosen among those who may often see VC and VF and are already familiar with the traditional scoring systems for both VC and VF (one radiologist and one spine orthopaedics from IOR, one nephrologist from the National Research Council and one internist from University of Padua).
Each clinician will assess all radiographs to score VC and QVM, both via computer assisted procedures and via traditional visual inspection. To avoid bias, an interval of at least one week will be left between the computer assisted and visual scoring. To define intra-observer variability (i.e. repeatability), the whole dataset will be re-assessed three times.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vascular Calcification Group | – | Diagnostic Test: Score of abdominal aorta calcificationsPatients with prevalent vascular calcifications will be analysed to verify the intra- and inter-observer reliability of the score of abdominal aorta calcifications |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients that were included in a previous interventional trial of the sponsor institution aimed to compare the effectiveness of vertebroplastic and kyphoplastic augmentations of the throracolumbar spine. The choice of this population was driven by previous reports on similar populations stating a high prevalence of vascular calcifications.
Key inclusion criteria (4 listed)
- Patients included in a previous interventional study (VTP vs KYPHO) of the sponsor.
- Availability of diagnostic images (Dorso-lumbar radiographies taken in L-L projection).
- Rx images will be screened for the presence of VC, retaining only those showing VC.
- Informed consent obtained prior to any study analysis-evaluation.
Key exclusion criteria (1 listed)
- Images showing severe artefacts (usually due to presence of metallic devices) that alter the grayscale range and hinder correct identification of VC and vertebral fractures
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 |
|---|---|---|
| Score of abdominal aorta calcificationsAlso: Score of lumbar spine vertebral fracturesRadiographs showing VC will be used to assess whether the computer assisted VC scoring (primary objective) and Quantitative Vertebral Morphometry (QVM, limited to lumbar spine, secondary objective n.1) through the Calcify2D software are less variable with respect to the traditional visual scoring of VC and QVM. | Diagnostic test | Vascular Calcification Group |
Primary outcome
Observer variability in scoring Vascular Calcification at the abdominal aorta
Time frame: through study completion, 1 year at maximum
Observer variability (repeatability and reproducibility) in the assessment of vascular calcifications at the abdominal aorta according to a widely adopted scoring system (Kauppila et al., 1997): comparison between computer assisted and visual scoring.
3 secondary outcomes
Observer variability in scoring Vertebral Fractures at the lumbar spine
Time frame: through study completion, 1 year at maximum
Accuracy of computer assisted VC score
Time frame: through study completion, 1 year at maximum
Accuracy of computer assisted QVM
Time frame: through study completion, 1 year at maximum
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 24 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Enrico Schileo, Ph.D. principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Calcification and Vertebral Fracture, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 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: finished, as of the sponsor's last update on 24 May 2023. 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 Italy. 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?
Observer variability in scoring Vascular Calcification at the abdominal aorta (time frame: through study completion, 1 year at maximum). 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 24 May 2023.