An observational study in Vascular Calcification and Vertebral Fracture, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-05-24.
Sponsored by Istituto Ortopedico Rizzoli · Observational
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.
82 studies on the registry are indexed under Vascular Calcification; 17 are open to participants now.
This study's enrollment of 44 is below the median of 80 across 23 observational studies indexed under Vascular Calcification.
Browse Vascular Calcification studies →Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with prevalent vascular calcifications will be analysed to verify the intra- and inter-observer reliability of the score of abdominal aorta calcifications
Diagnostic Test: Score of abdominal aorta calcifications
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.
Also known as: Score of lumbar spine vertebral fractures
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.
Time frame: through study completion, 1 year at maximum
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.
Time frame: 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
Time frame: 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
Time frame: through study completion, 1 year at maximum
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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