Cardiac AmyloidosisCASS-INCT05701410
Prevalence of Cardiac Amyloidosis Among Patients With a History of Lumbar Spinal Stenosis.
A study testing DPD scintigraphy in people with Cardiac Amyloidosis and Spinal Stenosis, run by Steen Hvitfeldt Poulsen at 1 site in Denmark.
Trial summary
The study investigates the prevalence of cardiac amyloidosis among patients with a history of lumbar spinal stenosis within the last ten years in the region of central Denmark. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cardiac Amyloidosis, Spinal Stenosis
- What is being tested?
- DPD scintigraphy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of lumbar spinal stenosis.
- Age > 60 years at the time of spinal stenosis surgery.
- Written informed consent.
Who cannot join
- Known amyloidosis
- Myelomatosis
- Monoclonal gammopathy of unknown origin, MGUS
- Morbus Waldenstrøm
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Cardiology, Aarhus University Hospital
Aarhus, 8200
Bertil Ladefoged, 40927245, berlad@rm.dk
About this study
The study investigates the prevalence of cardiac amyloidosis among patients with a history of lumbar spinal stenosis within the last ten years in the region of central Denmark.
- Conditions
- Cardiac Amyloidosis, Spinal Stenosis
- Being tested
- DPD scintigraphy
- Medical subject headings
- Amyloid Neuropathies, Familial, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPD scintigraphyDiagnostic test
Bone tracer scintigraphy, diagnostic for transthyretin amyloidosis.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients with a history of lumbar spinal stenosis. Receives: Diagnostic Test: DPD scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of cardiac amyloidosis
DPD scintigraphy with a Perugini Grade 2 og higher.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Jan 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Apr 2024 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steen Hvitfeldt Poulsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steen Hvitfeldt Poulsen, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701410
- Sponsor's protocol ID
- 1-10-72-117-22
- Acronym
- CASS-I
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 27 Jan 2023
- Results posted
- 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 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Cardiac Amyloidosis Among Patients With a History of Lumbar Spinal Stenosis.
- ClinicalTrials.gov ID
- NCT05701410
- Acronym / sponsor ID
- CASS-I / 1-10-72-117-22
- Conditions
- Cardiac Amyloidosis, Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Steen Hvitfeldt PoulsenUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 27 Jan 2023 (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.
The study investigates the prevalence of cardiac amyloidosis among patients with a history of lumbar spinal stenosis within the last ten years in the region of central Denmark.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Diagnostic Test: DPD scintigraphyPatients with a history of lumbar spinal stenosis. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of lumbar spinal stenosis.
- Age > 60 years at the time of spinal stenosis surgery.
- Written informed consent.
Key exclusion criteria (4 listed)
- Known amyloidosis
- Myelomatosis
- Monoclonal gammopathy of unknown origin, MGUS
- Morbus Waldenstrøm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPD scintigraphyBone tracer scintigraphy, diagnostic for transthyretin amyloidosis. | Diagnostic test | Study group |
Primary outcome
Diagnosis of cardiac amyloidosis
Time frame: 1 year
DPD scintigraphy with a Perugini Grade 2 og higher.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DPD scintigraphy in people with Cardiac Amyloidosis and Spinal Stenosis, run by Steen Hvitfeldt Poulsen at 1 site in Denmark.
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 4 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: status not confirmed, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bertil Ladefoged, MD (+45 40927245, berlad@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of cardiac amyloidosis (time frame: 1 year). 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 27 Jan 2023.