Unmasking the Prevalence of AC in an Unselected Echocardiographic Population

• Conditions: Amyloid Cardiomyopathy

• Registration Number: NCT04738266
• Lead Sponsor: University of Trieste

Brief Summary

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

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).

Study Timeline

• Study Start: 2020-11-20
• Primary Completion: 2021-01-20
• Study First Submitted: 2021-01-28
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-03
• Last Update Submitted: 2021-02-03
• Study First Posted: 2021-02-04
• Last Update Posted: 2021-02-04
• Study Completion: 2021-07-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 381

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prevalence of Amyloid Cardiomyopathy	3 months	The prevalence of Amyloid Cardiomyopathy in unselected echocardiographic population of patients aged \> 55 years
The prevalence of echocardiographic red flags of Amyloid Cardiomyopathy	6 months	The prevalence of echocardiographic red flags of Amyloid Cardiomyopathy in unselected echocardiographic population of patients aged \> 55 years
The diagnostic accuracy of echocardiographic red flags of Amyloid Cardiomyopathy	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Multiparametric echocardiographic score	6 months	Multiparametric echocardiographic score to predict the presence of Amyloid Cardiomyopathy

Trial Locations

Locations (16)

Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara; 🇮🇹 Ferrara, Italy

Cardiovascular Unit, Department of Internal Medicine, University of Genova; 🇮🇹 Genova, Italy

Istituto di Scienze della Vita, Scuola Superiore Sant'Anna; 🇮🇹 Pisa, Italy

Cardiology, Department of Medical and Surgical Specialities, Radiological Sciences and Public Health - University of Brescia; 🇮🇹 Brescia, Italy

Department of Clinical and Molecular Medicine, Faculty of Medicine and Psychology, Sapienza University; 🇮🇹 Roma, Italy

Cardiovascular Department, Policlinico Sant'Orsola; 🇮🇹 Bologna, Italy

Centre for Diagnosis and Treatment of Cardiomyopathies, Cardiovascular Department, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI); 🇮🇹 Trieste, Italy

Emergency Department and Amyloid Research and Treatment Center, IRCCS Policlinico San Matteo Foundation, Department of Internal Medicine, University of Pavia; 🇮🇹 Pavia, Milano, Italy

Department of Translational Medical Sciences, Inherited and Rare Heart Disease, Vanvitelli Cardiology, University of Campania Luigi Vanvitelli; 🇮🇹 Napoli, Italy

University Cardiology A.O.U., Città della Salute e della Scienza di Torino; 🇮🇹 Torino, Italy

Department of medicine and surgery, University Milano-Bicocca; 🇮🇹 Milano, Italy

Cardiomyopathy Unit, Careggi University Hospital; 🇮🇹 Firenze, Italy

Division of Cardiology, University of Siena; 🇮🇹 Siena, Italy

Department of Cardiology, University of Messina; 🇮🇹 Messina, Italy

Department of Cardiovascular, Neural and Metabolic Sciences - Istituto Auxologico Italiano; 🇮🇹 Milano, Italy

Cardiology Unit, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro; 🇮🇹 Bari, Italy