A Prospective Study to Assess the Utility of CA-4F in a Canadian Cardiology Setting
试验速览
- 阶段
- 不适用
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Clinical utility of CA-4F
研究概览
简要总结
This study will assess whether CA-4F can improve diagnosis of ATTR-CM in a community cardiology setting when used to screen electronic medical record data for patients suitable for follow-up investigations.
详细描述
This is a prospective multicentre observational study to assess whether CA-4F can improve diagnosis of ATTR-CM in a community cardiology setting when used to screen electronic medical record data for patients suitable for follow-up investigations.
The algorithm will be used to screen electronic health records of participating cardiologists for patients suitable for PYP scans to investigate potential ATTR-CM and determine its positive predictive value.
Input parameters to the algorithm will be extracted from the pseudonymized electronic health records of patients who visited participating cardiologists in the 12 months preceding their enrolment.
The records of patients with elevated pre-test likelihood of ATTR-CM will be queried for Canadian Heart Failure Society red flag symptoms to facilitate clinical review. Participating cardiologists will review the red flag symptoms and electronic health records of patients with elevated pre-test likelihoods and document whether further investigation with PYP is clinically justified with supporting rationale.
Patients for which further investigation is clinically justified will be referred for confirmatory testing and the results of additional investigations will be documented. The positive predictive values of "moderate", "high" and "very high" CA-4F Risk Scores will be calculated by determining the percentage of those patients for which further investigations were performed and resulted in diagnosis of ATTR-CM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Licensed cardiologist in the Canadian provinces of Ontario, Saskatchewan or British Columbia
- •Outpatient cardiology practice with ≥1,200 unique patients annually
- •Have used an electronic medical record system for ≥36 months from enrollment
- •Currently subscribed to the Advanced Computing Platform by Ensho Health or using a cloud-hosted electronic medical record system compatible with the Apollo Electronic Data Capture System
- •Experience with the clinical management of ATTR-CM
- •Access to PYP scanning for follow-up investigations
- •Previous participation in clinical studies
排除标准
- •Predominantly hospital-based cardiology practice
- •Have used an electronic medical record system for <36 months from enrollment
- •Electronic medical record system incompatible with the Apollo Electronic Data Capture system
- •No prior experience with the clinical management of ATTR-CM
- •No access to PYP scanning for follow-on investigations
- •No prior participation in clinical studies
结局指标
主要结局
Clinical utility of CA-4F
时间窗: Six months
Positive predictive value of "moderate" or greater CA-4F Risk Score as confirmed by PYP scan
次要结局
- Optimal threshold for clinical use(Six months)