NCT04653675: CASS

Cardiac Amyloidosis in Spinal Stenosis: the CASS-study

Active, enrolled Last updated 7 August 2024

What this trial tests

trial in Cardiac Amyloidosis in 105 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 January 2021

Primary endpoint
30 June 2022

31 December 2025

Quick facts

Lead sponsor	AZ Sint-Jan AV
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	105
Start date	1 January 2021
Primary completion	30 June 2022
Estimated completion	31 December 2025
Sites	1 location across Belgium

Conditions studied

• Cardiac Amyloidosis — all drugs for Cardiac Amyloidosis →

Sponsor

AZ Sint-Jan AV — full company profile →

Who can join

18 and older, any sex, with Cardiac Amyloidosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Prospective Screening for Transthyretin Cardiac Amyloidosis in Spinal Stenosis Surgery Patients: Results of the CASS Study.
   Debonnaire P, Claeys M, De Paepe P, Christiaen E, et al · · 2023 · cited 7× · PMID 38204999 · DOI 10.1016/j.jaccao.2023.05.012