Clinical trial NCT04738266: Unmasking the Prevalence of AC in an Unselected Echocardiographic Population
Official title: A National Survey of Prevalence and Accuracy of Echocardiographic Red Flags of Amyloid Cardiomyopathy in Consecutive Patients Undergoing Routine Echocardiography.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amyloid Cardiomyopathy
Keywords: Amyloid Cardiomyopathy
Echocardiography
Red flags
Epidemiology
Bone tracer cardiac scintigraphy
Lead sponsor: University of Trieste
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2021-02-04
Enrollment: 381
Sex: ALL
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive inpatients and outpatients subjects aged ≥55 years undergoing routine, clinically-indicated echocardiography at the laboratories of participating centers.

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).

Eligibility criteria: 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

Primary outcomes:
measure: The prevalence of Amyloid Cardiomyopathy
timeFrame: 3 months
measure: The prevalence of echocardiographic red flags of Amyloid Cardiomyopathy
timeFrame: 6 months
measure: The diagnostic accuracy of echocardiographic red flags of Amyloid Cardiomyopathy
timeFrame: 6 months
Secondary outcomes:
measure: Multiparametric echocardiographic score
timeFrame: 6 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Emergency Department and Amyloid Research and Treatment Center, IRCCS Policlinico San Matteo Foundation, Department of Internal Medicine, University of Pavia
state: Milano
city: Bari
country: Italy
facility: Cardiology Unit, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro
city: Bologna
country: Italy
facility: Cardiovascular Department, Policlinico Sant'Orsola
city: Brescia
country: Italy
facility: Cardiology, Department of Medical and Surgical Specialities, Radiological Sciences and Public Health - University of Brescia
city: Ferrara
country: Italy
facility: Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara
city: Firenze
country: Italy
facility: Cardiomyopathy Unit, Careggi University Hospital
city: Genova
country: Italy
facility: Cardiovascular Unit, Department of Internal Medicine, University of Genova
city: Messina
country: Italy
facility: Department of Cardiology, University of Messina
city: Milano
country: Italy
facility: Department of medicine and surgery, University Milano-Bicocca
city: Milano
country: Italy
facility: Department of Cardiovascular, Neural and Metabolic Sciences - Istituto Auxologico Italiano
city: Napoli
country: Italy
facility: Department of Translational Medical Sciences, Inherited and Rare Heart Disease, Vanvitelli Cardiology, University of Campania Luigi Vanvitelli
city: Pisa
country: Italy
facility: Istituto di Scienze della Vita, Scuola Superiore Sant'Anna
city: Roma
country: Italy
facility: Department of Clinical and Molecular Medicine, Faculty of Medicine and Psychology, Sapienza University
city: Siena
country: Italy
facility: Division of Cardiology, University of Siena
city: Torino
country: Italy
facility: University Cardiology A.O.U., Città della Salute e della Scienza di Torino
city: Trieste
country: Italy
facility: Centre for Diagnosis and Treatment of Cardiomyopathies, Cardiovascular Department, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI)
Study officials:
affiliation: Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI) and University of Trieste
name: Gianfranco Sinagra, MD, Full Professor
role: STUDY_CHAIR
affiliation: Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara - Ferrara
name: Claudio Rapezzi, MD, Full Professor
role: STUDY_CHAIR
References:
citation: Maurer MS, Bokhari S, Damy T, Dorbala S, Drachman BM, Fontana M, Grogan M, Kristen AV, Lousada I, Nativi-Nicolau J, Cristina Quarta C, Rapezzi C, Ruberg FL, Witteles R, Merlini G. Expert Consensus Recommendations for the Suspicion and Diagnosis of Transthyretin Cardiac Amyloidosis. Circ Heart Fail. 2019 Sep;12(9):e006075. doi: 10.1161/CIRCHEARTFAILURE.119.006075. Epub 2019 Sep 4.
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