Status:
NOT_YET_RECRUITING
Validation of Different Diagnostic Modalities in the Detection of Cardiac Amyloidosis Among Patients With "Red Flags"
Lead Sponsor:
Assiut University
Conditions:
Cardiac Amyloidosis
Eligibility:
All Genders
Phase:
NA
Brief Summary
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 th...
Detailed Description
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 dis...
Eligibility Criteria
Inclusion
- "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.
Exclusion
- \- 1. Patient who refuse to give a consent to the following investigations. 2. 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.
- 3\. Patient with established diagnosis of other infiltrative cardiac disease.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06175858
Start Date
January 1 2024
End Date
May 1 2027
Last Update
December 19 2023
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