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 Type
OBSERVATIONAL
Enrollment
105
AZ Sint-Jan Brugge-Oostende AV
Bruges, Belgium
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
Time frame: 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
Time frame: 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)
Time frame: 12 months after spinal canal surgery
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.