Cardiac Amyloidosis in Spinal Stenosis: the CASS-study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Difference in diagnostic performance of NT-proBNP (pg/ml) and echocardiography, electrocardiography and ligamentum flavum biopsy
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cervical or lumbar spinal canal stenosis, scheduled for spinal surgery
- •> 18 years old
排除标准
- •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
结局指标
主要结局
Difference in diagnostic performance of NT-proBNP (pg/ml) and echocardiography, electrocardiography and ligamentum flavum biopsy
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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 NT-proBNP (pg/ml) 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 hs-Troponin T (ng/L) and echocardiography parameters(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))(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 NT-proBNP (pg/ml) and ligamentum flavum biopsy(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(6 months after spinal canal surgery)
- Difference in diagnostic performance of NT-proBNP (pg/ml) and electrocardiography parameters(12 months after spinal canal surgery)
研究者
Philippe Debonnaire
Principal Investigator
AZ Sint-Jan AV