Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04569903
Status:
RECRUITING
Last Update Posted:
2024-02-12
First Post:
2020-09-24
Brief Title:
Evaluation of a Claims-based Algorithm for the Identification of Transthyretin-mediated Amyloidosis ATTR Amyloidosis in Medical Records
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Evaluation of a Claims-based Algorithm for the Identification of ATTR Amyloidosis in Medical Records
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to evaluate the diagnostic performance of an algorithm in identifying patients with ATTR amyloidosis
Detailed Description:
A screening strategy to identify ATTR in the large background population of patients with one or more common ATTR manifestations would be of significant clinical value
In addition novel ATTR therapies have been recently made available or are currently in development in late-stage clinical trials As early diagnosis and treatment is expected to achieve better outcomes this makes the development and validation of an easily implemented rapid and electronically-enabled diagnostic algorithm especially important
A medical and pharmacy claims-based algorithm was developed to potentially identify patients at risk of having ATTR The goal of this study is to evaluate the ability of the algorithm to identify patients with ATTR by performing diagnostic clinical work up in patients that the algorithm identifies in a large dataset of patients at Yale
The primary objective of this study is to evaluate the diagnostic performance of the algorithm in identifying patients with ATTR amyloidosis
The secondary objective of this study is to estimate the clinical benefit of the algorithm as measured by the added diagnostic value ie the proportion or rate of patients who were previously undiagnosed The total obtained prevalence will be assessed and informally compared to the referral-based prevalence of ATTR amyloidosis patients at Yale
In addition novel ATTR therapies have been recently made available or are currently in development in late-stage clinical trials As early diagnosis and treatment is expected to achieve better outcomes this makes the development and validation of an easily implemented rapid and electronically-enabled diagnostic algorithm especially important
A medical and pharmacy claims-based algorithm was developed to potentially identify patients at risk of having ATTR The goal of this study is to evaluate the ability of the algorithm to identify patients with ATTR by performing diagnostic clinical work up in patients that the algorithm identifies in a large dataset of patients at Yale
The primary objective of this study is to evaluate the diagnostic performance of the algorithm in identifying patients with ATTR amyloidosis
The secondary objective of this study is to estimate the clinical benefit of the algorithm as measured by the added diagnostic value ie the proportion or rate of patients who were previously undiagnosed The total obtained prevalence will be assessed and informally compared to the referral-based prevalence of ATTR amyloidosis patients at Yale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000 | OTHER | CTGTY | None |