Cardiac AmyloidosisRISCANCT06921408
Retrospective Identification of Scintigraphic Cardiac Amyloidosis (RISCA)
An observational study of Cardiac Amyloidosis and Transthyretin Amyloidosis, run by University Hospital, Lille.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Amyloidosis, Transthyretin Amyloidosis
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent scintigraphy for reasons other than suspected amyloidosis
Who may be able to join
- 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
Who cannot join
- Patients under legal protection
- Patients refusing the reuse of their data after individual information
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Retrospective Identification of Scintigraphic Cardiac Amyloidosis Using Deep Learning-based Model
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.
- Conditions
- Cardiac Amyloidosis, Transthyretin Amyloidosis
- Keywords
- Cardiac Amyloidosis, Bone Scintigraphy, Deep learning
- Medical subject headings
- Amyloid Neuropathies, Familial, Amyloidosis, Hereditary, Transthyretin-Related
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac amyloidosis diagnosis
Measured: After the reassessment evaluation (one-day evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921408
- Sponsor's protocol ID
- 2024_0111
- Other IDs
- ID RCB Number
- Acronym
- RISCA
- Status last verified
- May 2026
- First submitted
- 3 Apr 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Identification of Scintigraphic Cardiac Amyloidosis Using Deep Learning-based Model
- ClinicalTrials.gov ID
- NCT06921408
- Acronym / sponsor ID
- RISCA / 2024_0111
- Conditions
- Cardiac Amyloidosis, Transthyretin Amyloidosis
- Keywords
- Cardiac Amyloidosis, Bone Scintigraphy, Deep learning
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent scintigraphy for reasons other than suspected amyloidosis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients under legal protection
- Patients refusing the reuse of their data after individual information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac amyloidosis diagnosis
Time frame: After the reassessment evaluation (one-day evaluation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Amyloidosis and Transthyretin Amyloidosis, run by University Hospital, Lille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc-Antoine DELBARRE (+33 3 20 44 59 69, marcantoine.delbarre@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac amyloidosis diagnosis (time frame: After the reassessment evaluation (one-day evaluation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.