NCT04569903

Brief Summary

The primary objective of this study is to evaluate the diagnostic performance of an algorithm in identifying patients with ATTR amyloidosis.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2022

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
1.8 years until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

September 24, 2020

Last Update Submit

September 12, 2025

Conditions

Transthyretin Amyloidosis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance of algorithm in identifying patients with ATTR amyloidosis

    Potential thresholds for defining diagnostic positivity based on the calculated algorithmic scores will be explored and the corresponding positive predictive value (PPV) will serve as indicator for the diagnostic performance. Negative predictive values (NPV) may be explored if the actual distribution of score data will allow for it.

    2 years

Secondary Outcomes (1)

  • Proportion of diagnosed patients

    2 years

Study Arms (1)

Computer algorithm for ATTR

EXPERIMENTAL

Patients will be evaluated for the identification of ATTR Amyloidosis through a claims-based algorithm

Device: Computer algorithm for ATTR

Interventions

Computer algorithm for ATTRDEVICE

Patients will be evaluated for the identification of ATTR Amyloidosis through a claims-based algorithm

Computer algorithm for ATTR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Identified by the ATTR diagnostic algorithm and matched by Yale's list of potential subjects defined as:
  • subjects within the claims dataset that are predicted to be at risk of having ATTR who are also being managed within YNHHS
  • patients who need to be contacted and offered additional clinical evaluation to determine whether they have a diagnosis of ATTR (non-hereditary or Hereditary ATTR amyloidosis).

You may not qualify if:

  • Patients who have opted out of research in the Epic system will be excluded entirely from the study
  • Patients who are pregnant or who may become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Amyloidosis, Hereditary, Transthyretin-Related

Study Officials

  • Edward Miller, MD

    Yale University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2020

First Posted

September 30, 2020

Study Start

August 1, 2022

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations

US(1)