Cardiac AmyloidosisCASSNCT04653675
Cardiac Amyloidosis in Spinal Stenosis: the CASS-study
An observational study of Cardiac Amyloidosis, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
Background: A significant portion of cardiac amyloidosis patients have a 5 to 10 years prior history of spinal canal stenosis, reflecting a diagnostic red flag that should raise suspicion for amyloidosis presence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Amyloidosis
- How many people
- 105 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2021to 31 Dec 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cervical or lumbar spinal canal stenosis scheduled for spinal surgery
Who may be able to join
- Cervical or lumbar spinal canal stenosis, scheduled for spinal surgery
- > 18 years old
Who cannot join
- Prior diagnosis of cardiac amyloidosis and evident alternative explanations for troponin and/or NT-proBNP elevation are the main reasons for exclusion.
- known cardiac amyloidosis
- severe valvular regurgitation or stenosis
- Left ventricular ejection fraction (LVEF) < 40%
- Glomerular filtration rate (GFR) ≤ 25 ml/kg/min or dialysis
- recent heart failure admission ≤ 1 month
Show all 12Show fewer
- recent myocarditis ≤ 3 months
- recent acute coronary syndrome ≤ 1 month
- recent percutaneous coronary intervention (PCI) ≤ 1 month
- recent cardiac surgery ≤ 3 months
- active or planned pregnancy
- unwilling to participate or provide signed informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Background: A significant portion of cardiac amyloidosis patients have a 5 to 10 years prior history of spinal canal stenosis, reflecting a diagnostic red flag that should raise suspicion for amyloidosis presence. Mild troponin release and NT-proBNP elevation, both serum cardiac biomarkers, often coincide with cardiac amyloidosis. Early cardiac amyloidosis treatment improves survival, warranting timely diagnosis.
Study aim: to test a prospective screening strategy, based on serum cardiac biomarkers, to increase early detection of cardiac amyloidosis in patients with spinal canal stenosis.
Read more
Design: Single-centre prospective observational non-interventional diagnostic study.
Methods: Consecutive patients during a one-year period in AZ Sint-Jan Bruges, without known cardiac amyloidosis history and scheduled for spinal canal stenosis surgery, will have cardiac evaluation including serum cardiac biomarker (high-sensitive troponin T and NT-proBNP) assessment, electrocardiography and transthoracic echocardiography. During surgery, all patients will undergo ligamentum flavum biopsy to evaluate presence and burden of transthyretin amyloid deposition (Congo-red staining and immune histochemistry). All patients with suspicion for cardiac amyloidosis will undergo further diagnostic testing (including laboratory test and bone scintigraphy). A chronologic cascade screening process will be used starting with abnormal serum cardiac biomarkers (high-sensitive troponin T ≥ 14 ng/ml and/or NT-proBNP > 125 pg/ml), followed by electrocardiography, transthoracic echocardiography and finally ligamentum flavum biopsy results. The diagnostic performance of this biomarker-based strategy will be compared to electrocardiography, echocardiography and ligamentum flavum biopsy.
Conclusion: It is hypothesised that serum cardiac biomarker testing in patients undergoing spinal canal stenosis surgery represents a simple and valuable prospective screening strategy for early detection of cardiac amyloid(osis).
- Conditions
- Cardiac Amyloidosis
- Medical subject headings
- Amyloid Neuropathies, Familial
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance hs-Troponin T (ng/L) to early diagnose cardiac amyloidosis
Diagnostic performance of a prospective screening strategy, based on elevated hs-Troponin T (ng/L), in patients with spinal canal stenosis undergoing spinal surgery, to early diagnose cardiac amyloidosis
Measured: 12 months after spinal canal surgery
Diagnostic performance of NT-proBNP (pg/ml) to early diagnose cardiac amyloidosis
Diagnostic performance of a prospective screening strategy, based on elevated NT-proBNP (pg/ml), in patients with spinal canal stenosis undergoing spinal surgery, to early diagnose cardiac amyloidosis
Measured: 12 months after spinal canal surgery
Difference in diagnostic performance of NT-proBNP (pg/ml) and echocardiography, electrocardiography and ligamentum flavum biopsy
Difference in diagnostic performance of NT-proBNP (pg/ml) with CA suspicion based on echocardiography (left ventricular wall thickness), electrocardiography (QRS amplitude, presence of atrial fibrillation) and ligamentum flavum biopsy (presence of transthyretin-amyloid deposits)
Measured: 12 months after spinal canal surgery
Secondary outcomes (9)
Difference in diagnostic performance of hs-Troponin T (ng/L) and electrocardiography parameters
Difference in diagnostic performance of hs-Troponin T (ng/L) with CA suspicion based on electrocardiography (QRS amplitude, presence of atrial fibrillation)
Measured: 12 months after spinal canal surgery
Difference in diagnostic performance of hs-Troponin T (ng/L) and echocardiography parameters
Difference in diagnostic performance of hs-Troponin T (ng/L) with CA suspicion based on echocardiography (left ventricular wall thickness)
Measured: 12 months after spinal canal surgery
Difference in diagnostic performance of hs-Troponin T (ng/L) and ligamentum flavum biopsy
Difference in diagnostic performance of hs-Troponin T (ng/L) with CA suspicion based on ligamentum flavum biopsy (presence of transthyretin-amyloid deposits)
Measured: 12 months after spinal canal surgery
Difference in diagnostic performance of NT-proBNP (pg/ml) and echocardiography parameters
Difference in diagnostic performance of NT-proBNP (pg/ml) with CA suspicion based on echocardiography (left ventricular wall thickness)
Measured: 12 months after spinal canal surgery
Difference in diagnostic performance of NT-proBNP (pg/ml) and electrocardiography parameters
Difference in diagnostic performance of NT-proBNP (pg/ml) with CA suspicion based on electrocardiography (QRS amplitude, presence of atrial fibrillation)
Measured: 12 months after spinal canal surgery
Difference in diagnostic performance of NT-proBNP (pg/ml) and ligamentum flavum biopsy
Difference in diagnostic performance of NT-proBNP (pg/ml) with CA suspicion based on ligamentum flavum biopsy (presence of transthyretin-amyloid deposits)
Measured: 12 months after spinal canal surgery
To determine the prevalence of TTR amyloid in both cervical and lumbar spinal canal stenosis patients as function of age and clinical presentation
Measured: 6 months after spinal canal surgery
To correlate TTR amyloid burden on ligamentum flavum biopsy to echocardiographic (e.g. ventricular wall thickness) parameters
Measured: 12 months after spinal canal surgery
To correlate TTR amyloid burden on ligamentum flavum biopsy to cardiac biomarker parameters (e.g. hs-Troponin T (ng/L))
Measured: 12 months after spinal canal surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Jan 2021
- Primary completion30 Jun 2022
- Study completion31 Dec 2025 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Debonnaire, AZ Sint-Jan AV
- Investigators
- Philippe Debonnaire, MD, PhD, Principal investigator, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653675
- Sponsor's protocol ID
- 2741
- Acronym
- CASS
- Status last verified
- Aug 2024
- First submitted
- 19 Nov 2020
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Amyloidosis in Spinal Stenosis: the CASS-study
- ClinicalTrials.gov ID
- NCT04653675
- Acronym / sponsor ID
- CASS / 2741
- Conditions
- Cardiac Amyloidosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Dec 2020 (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.
Background: A significant portion of cardiac amyloidosis patients have a 5 to 10 years prior history of spinal canal stenosis, reflecting a diagnostic red flag that should raise suspicion for amyloidosis presence. Mild troponin release and NT-proBNP elevation, both serum cardiac biomarkers, often coincide with cardiac amyloidosis. Early cardiac amyloidosis treatment improves survival, warranting timely diagnosis.
Study aim: to test a prospective screening strategy, based on serum cardiac biomarkers, to increase early detection of cardiac amyloidosis in patients with spinal canal stenosis.
Design: Single-centre prospective observational non-interventional diagnostic study.
Methods: Consecutive patients during a one-year period in AZ Sint-Jan Bruges, without known cardiac amyloidosis history and scheduled for spinal canal stenosis surgery, will have cardiac evaluation including serum cardiac biomarker (high-sensitive troponin T and NT-proBNP) assessment, electrocardiography and transthoracic echocardiography. During surgery, all patients will undergo ligamentum flavum biopsy to evaluate presence and burden of transthyretin amyloid deposition (Congo-red staining and immune histochemistry). All patients with suspicion for cardiac amyloidosis will undergo further diagnostic testing (including laboratory test and bone scintigraphy). A chronologic cascade screening process will be used starting with abnormal serum cardiac biomarkers (high-sensitive troponin T ≥ 14 ng/ml and/or NT-proBNP > 125 pg/ml), followed by electrocardiography, transthoracic echocardiography and finally ligamentum flavum biopsy results. The diagnostic performance of this biomarker-based strategy will be compared to electrocardiography, echocardiography and ligamentum flavum biopsy.
Conclusion: It is hypothesised that serum cardiac biomarker testing in patients undergoing spinal canal stenosis surgery represents a simple and valuable prospective screening strategy for early detection of cardiac amyloid(osis).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cervical or lumbar spinal canal stenosis scheduled for spinal surgery
Key inclusion criteria (2 listed)
- Cervical or lumbar spinal canal stenosis, scheduled for spinal surgery
- > 18 years old
Key exclusion criteria (12 listed)
- Prior diagnosis of cardiac amyloidosis and evident alternative explanations for troponin and/or NT-proBNP elevation are the main reasons for exclusion.
- known cardiac amyloidosis
- severe valvular regurgitation or stenosis
- Left ventricular ejection fraction (LVEF) < 40%
- Glomerular filtration rate (GFR) ≤ 25 ml/kg/min or dialysis
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
Diagnostic performance hs-Troponin T (ng/L) to early diagnose cardiac amyloidosis
Time frame: 12 months after spinal canal surgery
Diagnostic performance of a prospective screening strategy, based on elevated hs-Troponin T (ng/L), in patients with spinal canal stenosis undergoing spinal surgery, to early diagnose cardiac amyloidosis
Diagnostic performance of NT-proBNP (pg/ml) to early diagnose cardiac amyloidosis
Time frame: 12 months after spinal canal surgery
Diagnostic performance of a prospective screening strategy, based on elevated NT-proBNP (pg/ml), in patients with spinal canal stenosis undergoing spinal surgery, to early diagnose cardiac amyloidosis
Difference in diagnostic performance of NT-proBNP (pg/ml) and echocardiography, electrocardiography and ligamentum flavum biopsy
Time frame: 12 months after spinal canal surgery
Difference in diagnostic performance of NT-proBNP (pg/ml) with CA suspicion based on echocardiography (left ventricular wall thickness), electrocardiography (QRS amplitude, presence of atrial fibrillation) and ligamentum flavum biopsy (presence of transthyretin-amyloid deposits)
9 secondary outcomes
Difference in diagnostic performance of hs-Troponin T (ng/L) and electrocardiography parameters
Time frame: 12 months after spinal canal surgery
Difference in diagnostic performance of hs-Troponin T (ng/L) and echocardiography parameters
Time frame: 12 months after spinal canal surgery
Difference in diagnostic performance of hs-Troponin T (ng/L) and ligamentum flavum biopsy
Time frame: 12 months after spinal canal surgery
Difference in diagnostic performance of NT-proBNP (pg/ml) and echocardiography parameters
Time frame: 12 months after spinal canal surgery
Difference in diagnostic performance of NT-proBNP (pg/ml) and electrocardiography parameters
Time frame: 12 months after spinal canal surgery
Difference in diagnostic performance of NT-proBNP (pg/ml) and ligamentum flavum biopsy
Time frame: 12 months after spinal canal surgery
To determine the prevalence of TTR amyloid in both cervical and lumbar spinal canal stenosis patients as function of age and clinical presentation
Time frame: 6 months after spinal canal surgery
To correlate TTR amyloid burden on ligamentum flavum biopsy to echocardiographic (e.g. ventricular wall thickness) parameters
Time frame: 12 months after spinal canal surgery
To correlate TTR amyloid burden on ligamentum flavum biopsy to cardiac biomarker parameters (e.g. hs-Troponin T (ng/L))
Time frame: 12 months after spinal canal surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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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.
Philippe Debonnaire, MD, PhD principal investigator
AZ Sint-Jan AV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Amyloidosis, run by AZ Sint-Jan AV at 1 site in Belgium.
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 2 inclusion and 12 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 7 Aug 2024. 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 Belgium. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance hs-Troponin T (ng/L) to early diagnose cardiac amyloidosis (time frame: 12 months after spinal canal surgery). The study lists 3 primary outcomes in all. 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 7 Aug 2024.