Retrospective Identification of Scintigraphic Cardiac Amy... | NCT06921408

Studies
Retrospective Identification of Scintigraphic Cardiac Amyloidosis (RISCA)

NCT06921408

Sponsor

University Hospital, Lille

Status

Not yet recruiting

Last Update Posted

May 15, 2026Actual

Enrollment

57Estimated

Phase

Not provided

Conditions

Cardiac Amyloidosis
Transthyretin Amyloidosis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ID RCB Number	Other Identifier	2024-A01194-43

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Jul 1, 2027Estimated

Completion Date

Dec 1, 2027Estimated

First Submitted Date

Apr 3, 2025

First Submission Date that Met QC Criteria

Apr 3, 2025

First Posted Date

Apr 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2026

Last Update Posted Date

May 15, 2026Actual

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

57Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiac amyloidosis diagnosis		After the reassessment evaluation (one-day evaluation)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent scintigraphy for reasons other than suspected amyloidosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marc-Antoine DELBARRE	Contact	+33 3 20 44 59 69		marcantoine.delbarre@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D028227	Amyloid Neuropathies, Familial
C567782	Amyloidosis, Hereditary, Transthyretin-Related

Ancestor Terms

ID	Term
D020271	Heredodegenerative Disorders, Nervous System
D019636	Neurodegenerative Diseases
D009422	Nervous System Diseases
D017772	Amyloid Neuropathies

Browse Leaves

Not provided

Browse Branches

Not provided