Cardiac Amyloidosis in Spinal Stenosis: the CASS-study

NCT04653675 | Active Not Recruiting

• 1 other identifier: 2741
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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)

  12 months after spinal canal surgery

Secondary Outcomes (9)

• 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) and echocardiography 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 NT-proBNP (pg/ml) and echocardiography parameters

  12 months after spinal canal surgery

• Difference in diagnostic performance of NT-proBNP (pg/ml) and electrocardiography parameters

  12 months after spinal canal surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with cervical or lumbar spinal canal stenosis scheduled for spinal surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

AZ Sint-Jan Brugge-Oostende AV

Bruges, Belgium

Location

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

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

Study Officials

• Philippe Debonnaire, MD, PhD

  AZ Sint-Jan AV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 4, 2020
• Study Start: January 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

BE (1)