Status:
UNKNOWN
Unmasking the Prevalence of AC in an Unselected Echocardiographic Population
Lead Sponsor:
University of Trieste
Collaborating Sponsors:
Pfizer
Conditions:
Amyloid Cardiomyopathy
Eligibility:
All Genders
55-100 years
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 prev...
Detailed Description
Prospective multicenter Italian survey consisting of two phases: observational (echocardiographic screening for amyloid cardiomyopathy among patients ≥ 55 years undergoing clinically-indicated echocar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 25 2021
Estimated Enrollment :
381 Patients enrolled
Trial Details
Trial ID
NCT04738266
Start Date
November 20 2020
End Date
July 25 2021
Last Update
February 4 2021
Active Locations (16)
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1
Emergency Department and Amyloid Research and Treatment Center, IRCCS Policlinico San Matteo Foundation, Department of Internal Medicine, University of Pavia
Pavia, Milano, Italy, 27100
2
Cardiology Unit, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro
Bari, Italy, 70121
3
Cardiovascular Department, Policlinico Sant'Orsola
Bologna, Italy, 40138
4
Cardiology, Department of Medical and Surgical Specialities, Radiological Sciences and Public Health - University of Brescia
Brescia, Italy, 25100