Cardiac Amyloidosis in Spinal Stenosis: the CASS-study
- Conditions
- Cardiac Amyloidosis
- Registration Number
- NCT04653675
- Lead Sponsor
- AZ Sint-Jan AV
- Brief 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. 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 105
- Cervical or lumbar spinal canal stenosis, scheduled for spinal surgery
- > 18 years old
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in diagnostic performance of NT-proBNP (pg/ml) and echocardiography, electrocardiography and ligamentum flavum biopsy 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)
Diagnostic performance of NT-proBNP (pg/ml) to early diagnose cardiac amyloidosis 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
Diagnostic performance hs-Troponin T (ng/L) to early diagnose cardiac amyloidosis 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
- Secondary Outcome Measures
Name Time Method Difference in diagnostic performance of NT-proBNP (pg/ml) and echocardiography parameters 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)
To correlate TTR amyloid burden on ligamentum flavum biopsy to echocardiographic (e.g. ventricular wall thickness) parameters 12 months after spinal canal surgery Difference in diagnostic performance of hs-Troponin T (ng/L) and ligamentum flavum biopsy 12 months after spinal canal surgery Difference in diagnostic performance of hs-Troponin T (ng/L) with CA suspicion based on ligamentum flavum biopsy (presence of transthyretin-amyloid deposits)
Difference in diagnostic performance of hs-Troponin T (ng/L) and echocardiography parameters 12 months after spinal canal surgery Difference in diagnostic performance of hs-Troponin T (ng/L) with CA suspicion based on echocardiography (left ventricular wall thickness)
To correlate TTR amyloid burden on ligamentum flavum biopsy to cardiac biomarker parameters (e.g. hs-Troponin T (ng/L)) 12 months after spinal canal surgery Difference in diagnostic performance of hs-Troponin T (ng/L) and electrocardiography parameters 12 months after spinal canal surgery Difference in diagnostic performance of hs-Troponin T (ng/L) with CA suspicion based on electrocardiography (QRS amplitude, presence of atrial fibrillation)
Difference in diagnostic performance of NT-proBNP (pg/ml) and ligamentum flavum biopsy 12 months after spinal canal surgery Difference in diagnostic performance of NT-proBNP (pg/ml) with CA suspicion based on ligamentum flavum biopsy (presence of transthyretin-amyloid deposits)
To determine the prevalence of TTR amyloid in both cervical and lumbar spinal canal stenosis patients as function of age and clinical presentation 6 months after spinal canal surgery Difference in diagnostic performance of NT-proBNP (pg/ml) and electrocardiography parameters 12 months after spinal canal surgery Difference in diagnostic performance of NT-proBNP (pg/ml) with CA suspicion based on electrocardiography (QRS amplitude, presence of atrial fibrillation)
Trial Locations
- Locations (1)
AZ Sint-Jan Brugge-Oostende AV
🇧🇪Brugge, Belgium