Observer Variability in Scoring Abdominal Aortic Calcifications and Vertebral Morphometry (CALCIFY2D)

May 23, 2023 updated by: Istituto Ortopedico Rizzoli

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.

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 Overview

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • BO
      • Bologna, BO, Italy, 40136
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • Score of lumbar spine vertebral fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, 1 year at maximum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observer variability in scoring Vertebral Fractures at the lumbar spine
Time Frame: through study completion, 1 year at maximum
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.
through study completion, 1 year at maximum
Accuracy of computer assisted VC score
Time Frame: through study completion, 1 year at maximum
Accuracy of VC score computed by Calcify2D software will be tested against a gold standard CT-based score
through study completion, 1 year at maximum
Accuracy of computer assisted QVM
Time Frame: through study completion, 1 year at maximum
Accuracy of QVM score computed by Calcify2D software will be tested for the detection of mild vertebral fractures against gold standard Magnetic Resonance imaging
through study completion, 1 year at maximum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Enrico Schileo, Ph.D., Istituto Ortopedico Rizzoli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2018

Primary Completion (Actual)

October 31, 2019

Study Completion (Actual)

April 27, 2021

Study Registration Dates

First Submitted

February 8, 2019

First Submitted That Met QC Criteria

February 11, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vertebral Fracture

Clinical Trials on Score of abdominal aorta calcifications

3
Subscribe