Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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).
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amyloid Cardiomyopathy | Diagnostic Test | 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 |
| 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:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Multiparametric echocardiographic score | Multiparametric echocardiographic score to predict the presence of Amyloid Cardiomyopathy | 6 months |
Not provided
Inclusion Criteria:
All the following:
AND
At least one of the following criteria:
Exclusion Criteria:
Not provided
Not provided
Consecutive inpatients and outpatients subjects aged ≥55 years undergoing routine, clinically-indicated echocardiography at the laboratories of participating centers.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gianfranco Sinagra, MD, Full Professor | Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI) and University of Trieste | Study Chair |
| Claudio Rapezzi, MD, Full Professor | Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara - Ferrara | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Department and Amyloid Research and Treatment Center, IRCCS Policlinico San Matteo Foundation, Department of Internal Medicine, University of Pavia | Pavia | Milano | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31480867 | Background | 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. | |
| 31864973 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D028227 | Amyloid Neuropathies, Familial |
| ID | Term |
|---|---|
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
| D017772 | Amyloid Neuropathies |
Not provided
Not provided
Not provided
Not provided
Not provided
| Cardiology Unit, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro | Bari | 70121 | Italy |
| Cardiovascular Department, Policlinico Sant'Orsola | Bologna | 40138 | Italy |
| Cardiology, Department of Medical and Surgical Specialities, Radiological Sciences and Public Health - University of Brescia | Brescia | 25100 | Italy |
| Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara | Ferrara | 44121 | Italy |
| Cardiomyopathy Unit, Careggi University Hospital | Florence | 50134 | Italy |
| Cardiovascular Unit, Department of Internal Medicine, University of Genova | Genova | 16126 | Italy |
| Department of Cardiology, University of Messina | Messina | 98122 | Italy |
| Department of medicine and surgery, University Milano-Bicocca | Milan | 20126 | Italy |
| Department of Cardiovascular, Neural and Metabolic Sciences - Istituto Auxologico Italiano | Milan | 20149 | Italy |
| Department of Translational Medical Sciences, Inherited and Rare Heart Disease, Vanvitelli Cardiology, University of Campania Luigi Vanvitelli | Naples | 80131 | Italy |
| Istituto di Scienze della Vita, Scuola Superiore Sant'Anna | Pisa | 56127 | Italy |
| Department of Clinical and Molecular Medicine, Faculty of Medicine and Psychology, Sapienza University | Roma | 00155 | Italy |
| Division of Cardiology, University of Siena | Siena | 53100 | Italy |
| University Cardiology A.O.U., Città della Salute e della Scienza di Torino | Torino | 10126 | Italy |
| Centre for Diagnosis and Treatment of Cardiomyopathies, Cardiovascular Department, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI) | Trieste | 34149 | Italy |
| Background |
| 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. |
| 27143678 | Background | 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. |
| 28373528 | Background | 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. |
| 33032855 | Background | 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. |
| 27386769 | Background | 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. |
| 35417089 | Derived | 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. |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028226 | Amyloidosis, Familial |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |