Validation of Handheld Ultrasound Devices for Point of Care Use in Rheumatology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Intraarticular synovitis scoring
研究概览
简要总结
The goal of this clinical trial is to test the concurrent validity of the Clarius handheld ultrasound devices versus gold-standard device to detect characteristic features of healthy and rheumatic joints in adults Psoriatic Arthtritis patients (i.e. anatomical structures and vascular flow).
详细描述
This study is a clinical trial testing the concurrent validity of Clarius handheld ultrasound devices against the gold-standard device to detect characteristics (i.e., anatomical structures and vascular flow) of healthy and rheumatic joints in adult Psoriatic Arthritis patients.
The study will be conducted in 3 centers and 10 patients will be included in each center. Study patients will not be randomized to any group.
Both B mode and Doppler images of the participants' predetermined nail, joint, tendon and enthesitis areas will be recorded with both handheld (Clarius Mobile Health Inc, HD3 L15 scanner, HD3 L20 scanner) and the gold standard device (GE LogicE9/E10) at baseline visit.
Two paper CRFs, patient and physician CRFs, will be filled for each patient during the visit and these will be the source document. The CRFs (eCRFs) will be scanned and uploaded to the SharePoint at each center, within 3 days after the visit. In addition, US images of each patient will be uploaded to the SharePoint. The paper CRFs (source documents) will be kept on site. US images and CRFs uploaded from each center will be reviewed by the research assistant at Ottawa Hospital Research Institute (OHRI) center. If there are any missing or erroneous data in the CRF copy, research assistant will contact the site to ensured that the errors and deficiencies are corrected in source document according to Good Documentation Practice. Site should then re-scan the CRF to the SharePoint, ensuring sequential versioning. Any queries will be confirmed with the site within a week of the data entry. Then the analyzed CRFs data will be transferred to Research Electronic Data Capture (REDCap) ( version 12.4.18 - © 2023 Vanderbilt University) by the research assistant at OHRI. Before each analysis (interim and final), all the paper CRFs and REDCap data will be compared for quality assurance.
The scoring of the US images will be done blindly by the principal investigator at OHRI as stated below.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the classification for psoriatic arthritis (CASPAR) criteria
- •Able to provide an informed consent
- •Having peripheral disease phenotype of PsA
- •At least one tender and swollen join on the day of US
排除标准
- •Having isolated axial PsA
- •Being in MDA with no tender and swollen joints
结局指标
主要结局
Intraarticular synovitis scoring
时间窗: 6 months
After the imaging of all patients is completed, intraarticular synovitis scoring will be done based on the OMERACT definitions (scales of 0-3) as follows. Greyscale inflammatory (hypoechoic) synovial hyperplasia: Grade 0: no hypoechoic synovial hyperplasia Grade 1: minimal hypoechoic synovial hyperplasia (filling the angle between the periarticular bones, without bulging over the line linking tops of the bones) Grade 2: hypoechoic synovial hyperplasia bulging over the line linking tops of the periarticular bones but without extension along the bone diaphysis Grade 3: hypoechoic synovial hyperplasia bulging over the line linking tops of the periarticular bones and with extension to at least one of the bone diaphysis
次要结局
- Intraarticular Doppler scoring(6 months)
- Assessment of nail images(6 months)
- Assessment of tendon images(6 months)
- Assessment of entheses images(6 months)
研究者
Sibel Aydin
Professor
Ottawa Hospital Research Institute