Validation of Different Diagnostic Modalities in the Detection of Cardiac Amyloidosis Among Patients With "Red Flags"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Validation of different diagnostic modalities in the detection of cardiac amyloidosis among patients with "red flags"
研究概览
简要总结
The study aims to test and compare the diagnostic yield of different diagnostic modalities (speckle tracking echocardiography, CMR, serum and urine protein analysis and bone tracer scintigraphy) in the detection of cardiac amyloidosis among patients with "red flags" suspecting cardiac amyloidosis.
详细描述
Cardiac amyloidosis (CA) is a condition that can be caused by rare genetic variants in the hereditary forms or because of acquired conditions. It is one of the serious and progressive infiltrative disease that is caused by the deposition of amyloid fibrils at the cardiac level .
Cardiac amyloidosis causes restrictive cardiomyopathy, and this is caused by extracellular deposition of proteins in the myocardium. The proteins have an unstable structure that causes them to misfold, aggregate, and deposit as amyloid fibrils .
According to the nature of the infiltrating protein, cardiac amyloidosis has two main subtypes, immunoglobulin light chain cardiac amyloidosis (AL-CA), and transthyretin cardiac amyloidosis (ATTR-CA) which is further subdivided according to the presence or absence of a mutation in the transthyretin gene into wild-type (ATTRwt-CA) and variant (ATTRv-CA) .
Despite of being one of the most serious, fetal diseases, and a considerable cause of heart failure with preserved ejection fraction (HFpEF), cardiac amyloidosis is still significantly underdiagnosed, this may be due to its varied presentations and lack of awareness about the nature of the disease. Awareness of "red flags" suggestive of amyloidosis can enhance one's index of appropriate clinical suspicion and enable earlier diagnosis of CA .
Diagnosis of CA:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •"Red flags" include any one of the following:
- •Clinical "Red flags":
- •Bilateral carpal tunnel syndrome (30).
- •"Popeye sign", rupture of long head of the biceps tendon.
- •Lumbar spinal canal stenosis in association with unilateral carpal tunnel syndrome (31).
- •Echocardiographic/imaging "Red Flags"
- •LV wall thickness ≥ 12 mm and heart failure in men > 60 y/ women > 70y.
- •LV wall thickness ≥ 12 mm and AV-Block or pacemaker.
- •Infiltrative phenotype (biventricular hypertrophy, thickening of cardiac valves, pericardial effusion, thickening of the interatrial septum).
- •LV wall thickness ≥ 12 mm and low voltage on ECG.
- •Paradoxical low flow/low gradient aortic stenosis.
排除标准
- •Patient who refuse to give a consent to the following investigations.
- •Patient with any contra-indication to undergo CMR, or bone scintigraphy will be excluded e.g., non compatible implantable cardiac devices, claustrophobic, severe kidney function impairment.
- •Patient with established diagnosis of other infiltrative cardiac disease.
结局指标
主要结局
Validation of different diagnostic modalities in the detection of cardiac amyloidosis among patients with "red flags"
时间窗: Baseline
• Detect the diagnostic yield of different diagnostic modalities for detection of cardiac amyloidosis and compare them.
次要结局
- i. Identification of the percentage of patients who will have a final confirmed diagnosis of cardiac amyloidosis among all included patients with "red flags".(Baseline)
研究者
Alsayed Ali Mahmoud Ahmed
Resident
Assiut University