Evaluating a new algorithm to identify ATTR amyloidosis in medical records
Evaluation of a Claims-based Algorithm for the Identification of ATTR Amyloidosis in Medical Records
NA · Yale University · NCT04569903
This study is testing a new way to find people with transthyretin amyloidosis (ATTR) by looking at their medical records to see if it helps identify those who might not know they have it.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University (other) |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT04569903 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of a claims-based algorithm designed to identify patients with transthyretin amyloidosis (ATTR) by analyzing medical records. The algorithm targets a large population of patients who exhibit common symptoms associated with ATTR, facilitating early diagnosis and treatment. By performing diagnostic evaluations on patients flagged by the algorithm, the study seeks to determine its accuracy and clinical utility in identifying previously undiagnosed cases of ATTR. The findings could significantly enhance the early detection of this condition, which is crucial for improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients identified by the algorithm who are managed within the Yale New Haven Health System and may be at risk for ATTR.
Not a fit: Patients who have opted out of research or are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this algorithm could lead to earlier diagnosis and treatment of ATTR amyloidosis, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using algorithms for disease identification, but this specific approach for ATTR amyloidosis is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Identified by the ATTR diagnostic algorithm and matched by Yale's list of potential subjects defined as:
1. subjects within the claims dataset that are predicted to be at risk of having ATTR who are also being managed within YNHHS
2. 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).
Exclusion Criteria:
* 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
Where this trial is running
New Haven, Connecticut
- Yale New Haven Hospital — New Haven, Connecticut, United States (RECRUITING)
Study contacts
- Principal investigator: Edward Miller, MD — Yale University
- Study coordinator: Cinthia S De Freitas, RN, BSN
- Email: cinthia.defreitas@yale.edu
- Phone: (203)785-6315
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Transthyretin Amyloidosis