Unmasking the Prevalence of AC in an Unselected Echocardiographic Population
NCT ID: NCT04738266
Last Updated: 2021-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
381 participants
OBSERVATIONAL
2020-11-20
2021-07-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
100 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
University of Trieste
OTHER
Responsible Party
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Marco Merlo
MD, Associate Professor
Principal Investigators
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Gianfranco Sinagra, MD, Full Professor
Role: STUDY_CHAIR
Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI) and University of Trieste
Claudio Rapezzi, MD, Full Professor
Role: STUDY_CHAIR
Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara - Ferrara
Locations
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Emergency Department and Amyloid Research and Treatment Center, IRCCS Policlinico San Matteo Foundation, Department of Internal Medicine, University of Pavia
Pavia, Milano, Italy
Cardiology Unit, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro
Bari, , Italy
Cardiovascular Department, Policlinico Sant'Orsola
Bologna, , Italy
Cardiology, Department of Medical and Surgical Specialities, Radiological Sciences and Public Health - University of Brescia
Brescia, , Italy
Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara
Ferrara, , Italy
Cardiomyopathy Unit, Careggi University Hospital
Florence, , Italy
Cardiovascular Unit, Department of Internal Medicine, University of Genova
Genova, , Italy
Department of Cardiology, University of Messina
Messina, , Italy
Department of medicine and surgery, University Milano-Bicocca
Milan, , Italy
Department of Cardiovascular, Neural and Metabolic Sciences - Istituto Auxologico Italiano
Milan, , Italy
Department of Translational Medical Sciences, Inherited and Rare Heart Disease, Vanvitelli Cardiology, University of Campania Luigi Vanvitelli
Napoli, , Italy
Istituto di Scienze della Vita, Scuola Superiore Sant'Anna
Pisa, , Italy
Department of Clinical and Molecular Medicine, Faculty of Medicine and Psychology, Sapienza University
Roma, , Italy
Division of Cardiology, University of Siena
Siena, , Italy
University Cardiology A.O.U., Città della Salute e della Scienza di Torino
Torino, , Italy
Centre for Diagnosis and Treatment of Cardiomyopathies, Cardiovascular Department, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI)
Trieste, , Italy
Countries
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References
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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.
Boldrini M, Cappelli F, Chacko L, Restrepo-Cordoba MA, Lopez-Sainz A, Giannoni A, Aimo A, Baggiano A, Martinez-Naharro A, Whelan C, Quarta C, Passino C, Castiglione V, Chubuchnyi V, Spini V, Taddei C, Vergaro G, Petrie A, Ruiz-Guerrero L, Monivas V, Mingo-Santos S, Mirelis JG, Dominguez F, Gonzalez-Lopez E, Perlini S, Pontone G, Gillmore J, Hawkins PN, Garcia-Pavia P, Emdin M, Fontana M. Multiparametric Echocardiography Scores for the Diagnosis of Cardiac Amyloidosis. JACC Cardiovasc Imaging. 2020 Apr;13(4):909-920. doi: 10.1016/j.jcmg.2019.10.011. Epub 2019 Dec 18.
Gillmore JD, Maurer MS, Falk RH, Merlini G, Damy T, Dispenzieri A, Wechalekar AD, Berk JL, Quarta CC, Grogan M, Lachmann HJ, Bokhari S, Castano A, Dorbala S, Johnson GB, Glaudemans AW, Rezk T, Fontana M, Palladini G, Milani P, Guidalotti PL, Flatman K, Lane T, Vonberg FW, Whelan CJ, Moon JC, Ruberg FL, Miller EJ, Hutt DF, Hazenberg BP, Rapezzi C, Hawkins PN. Nonbiopsy Diagnosis of Cardiac Transthyretin Amyloidosis. Circulation. 2016 Jun 14;133(24):2404-12. doi: 10.1161/CIRCULATIONAHA.116.021612. Epub 2016 Apr 22.
Maurer MS, Elliott P, Comenzo R, Semigran M, Rapezzi C. Addressing Common Questions Encountered in the Diagnosis and Management of Cardiac Amyloidosis. Circulation. 2017 Apr 4;135(14):1357-1377. doi: 10.1161/CIRCULATIONAHA.116.024438.
Porcari A, Merlo M, Rapezzi C, Sinagra G. Transthyretin amyloid cardiomyopathy: An uncharted territory awaiting discovery. Eur J Intern Med. 2020 Dec;82:7-15. doi: 10.1016/j.ejim.2020.09.025. Epub 2020 Oct 5.
Maurer MS, Hanna M, Grogan M, Dispenzieri A, Witteles R, Drachman B, Judge DP, Lenihan DJ, Gottlieb SS, Shah SJ, Steidley DE, Ventura H, Murali S, Silver MA, Jacoby D, Fedson S, Hummel SL, Kristen AV, Damy T, Plante-Bordeneuve V, Coelho T, Mundayat R, Suhr OB, Waddington Cruz M, Rapezzi C; THAOS Investigators. Genotype and Phenotype of Transthyretin Cardiac Amyloidosis: THAOS (Transthyretin Amyloid Outcome Survey). J Am Coll Cardiol. 2016 Jul 12;68(2):161-72. doi: 10.1016/j.jacc.2016.03.596.
Merlo M, Pagura L, Porcari A, Cameli M, Vergaro G, Musumeci B, Biagini E, Canepa M, Crotti L, Imazio M, Forleo C, Cappelli F, Perfetto F, Favale S, Di Bella G, Dore F, Girardi F, Tomasoni D, Pavasini R, Rella V, Palmiero G, Caiazza M, Carella MC, Igoren Guaricci A, Branzi G, Caponetti AG, Saturi G, La Malfa G, Merlo AC, Andreis A, Bruno F, Longo F, Rossi M, Varra GG, Saro R, Di Ienno L, De Carli G, Giacomin E, Arzilli C, Limongelli G, Autore C, Olivotto I, Badano L, Parati G, Perlini S, Metra M, Emdin M, Rapezzi C, Sinagra G. Unmasking the prevalence of amyloid cardiomyopathy in the real world: results from Phase 2 of the AC-TIVE study, an Italian nationwide survey. Eur J Heart Fail. 2022 Aug;24(8):1377-1386. doi: 10.1002/ejhf.2504. Epub 2022 May 10.
Other Identifiers
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199_2019
Identifier Type: -
Identifier Source: org_study_id
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