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NCT Number: NCT04653675

Cardiac Amyloidosis in Spinal Stenosis: the CASS-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.

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiac Amyloidosis Amyloid Neuropathies Amyloid Neuropathies, Familial Amyloidosis Amyloidosis, Familial Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Sint-Jan Brugge-Oostende AV

Bruges, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cervical or lumbar spinal canal stenosis, scheduled for spinal surgery
  • > 18 years old

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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)

Secondary outcomes

  1. 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) with CA suspicion based on electrocardiography (QRS amplitude, presence of atrial fibrillation)

  2. 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) with CA suspicion based on echocardiography (left ventricular wall thickness)

  3. 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 hs-Troponin T (ng/L) with CA suspicion based on ligamentum flavum biopsy (presence of transthyretin-amyloid deposits)

  4. 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) with CA suspicion based on echocardiography (left ventricular wall thickness)

  5. 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) with CA suspicion based on electrocardiography (QRS amplitude, presence of atrial fibrillation)

  6. Difference in diagnostic performance of NT-proBNP (pg/ml) 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 ligamentum flavum biopsy (presence of transthyretin-amyloid deposits)

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Registry information

Acronym: CASS

Important dates

Study start
2021
Primary completion
2022
Study completion
2025
First posted
Dec 4, 2020
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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