Unmasking the Prevalence of AC in an Unselected Echocardiographic Population

Study Overview
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Brief Summary
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This study will investigate the prevalence of echocardiographic red-flags of amyloid cardiomyopathy (AC) in patients undergoing clinically-indicated echocardiography (observational phase) and the prevalence of AC among AC-suggestive echocardiograms (interventional phase).

Detailed Description
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Prospective multicenter Italian survey consisting of two phases: observational (echocardiographic screening for amyloid cardiomyopathy among patients ≥ 55 years undergoing clinically-indicated echocardiography) and interventional (specific clinical and instrumental work-up to detect the prevalence of amyloid cardiomyopathy among amyloid cardiomyopathy-suggestive echocardiograms).

Official Title
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A National Survey of Prevalence and Accuracy of Echocardiographic Red Flags of Amyloid Cardiomyopathy in Consecutive Patients Undergoing Routine Echocardiography.

Conditions
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Amyloid Cardiomyopathy

Intervention / Treatment
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* Diagnostic Test: Amyloid Cardiomyopathy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the following: Interventricular septum thickness ≥ 13 mm in men and ≥ 12 mm in women; Left ventricular ejection fraction ≥ 50%; Indexed end-diastolic left ventricular volume ≤ 85 mL/m2. AND At least one of the following criteria: Granular sparkling appearance of the myocardium defined granular texture with uniform increased brightness of echo-reflections; Pericardial effusion regardless of severity; Increased interatrial septum thickness (> 5 mm); Restrictive filling pattern (Dec. Time E wave <120 ms or Dec. Time E wave ≤150 ms e E/A ratio ≥2) or increased ventricular filling pressures (E/E'15); Speckle tracking derived global longitudinal strain with apical sparing pattern; Increased thickness (> 5 mm) of mitral and tricuspid valve leaflets. Exclusion Criteria: Patients aged < 55 years or > 100 years Echocardiography performed due to known or suspected amyloid cardiomyopathy; Echocardiography performed due to known hypertrophic cardiomyopathy or phenocopies; Refuse to sign the informed consent to the study

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Amyloid Cardiomyopathy|Echocardiographic red flags of Amyloid Cardiomyopathy to guide the suspicion of disease and to proceed with second level diagnostic work up including cardiac scintigraphy with bone tracers and search of monoclonal component in serum and urine|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of Amyloid Cardiomyopathy | The prevalence of Amyloid Cardiomyopathy in unselected echocardiographic population of patients aged > 55 years | 3 months | 
| The prevalence of echocardiographic red flags of Amyloid Cardiomyopathy | The prevalence of echocardiographic red flags of Amyloid Cardiomyopathy in unselected echocardiographic population of patients aged > 55 years | 6 months | 
| The diagnostic accuracy of echocardiographic red flags of Amyloid Cardiomyopathy | At the end of phase 2 of this study, patients with Amyloid Cardiomyopathy will be diagnosed, thus allowing to measure the diagnostic accuracy of the following echocardiographic red flags of Amyloid Cardiomyopathy: Restrictive filling pattern (E wave deceleration time <120 ms or ≤150 ms in presence of E/A ≥2) and/or E/E'≥15; Granular sparkling appearance of the myocardium; Pericardial effusion of any entity; Interatrial septum thickness >0.5 cm measured in subcostal or four-chamber view; Thickening of the atrio-ventricular (AV) valves (leaflets thickness >0.5 cm); Left ventricular apical sparing pattern at speckle-tracking echocardiography. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiparametric echocardiographic score | Multiparametric echocardiographic score to predict the presence of Amyloid Cardiomyopathy | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amyloid Cardiomyopathy, Echocardiography, Red flags, Epidemiology, Bone tracer cardiac scintigraphy