NCT06921408

Brief Summary

This study aims to determine the positive predictive value of incidental cardiac uptake on bone scintigraphy for diagnosing transthyretin cardiac amyloidosis, in patients who underwent scintigraphy for reasons other than suspected amyloidosis. The study is an observational, descriptive, multicenter, national study using retrospective data from routine care. Patients with incidental cardiac uptake will be recalled for further diagnostic assessment.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
15mo left

Started Sep 2026

Status
not yet recruiting

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

April 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

April 3, 2025

Last Update Submit

May 14, 2026

Conditions

Cardiac AmyloidosisTransthyretin Amyloidosis

Keywords

Cardiac AmyloidosisBone ScintigraphyDeep learning

Outcome Measures

Primary Outcomes (1)

  • Cardiac amyloidosis diagnosis

    After the reassessment evaluation (one-day evaluation)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent scintigraphy for reasons other than suspected amyloidosis

You may qualify if:

  • Adults (≥ 18 years)
  • Patients who underwent bone scintigraphy with 99mTc-HMDP/DPD/PYP for any indication
  • Incidental cardiac uptake (Perugini grade ≥2) confirmed by a nuclear medicine specialist

You may not qualify if:

  • Patients under legal protection
  • Patients refusing the reuse of their data after individual information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Amyloid Neuropathies, FamilialAmyloidosis, Hereditary, Transthyretin-Related

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesNervous System DiseasesAmyloid NeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmyloidosis, FamilialMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesAmyloidosisProteostasis Deficiencies

Central Study Contacts

Marc-Antoine DELBARRE

CONTACT

+33 3 20 44 59 69marcantoine.delbarre@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2025

First Posted

April 10, 2025

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share