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This registry is a observational, multi-center study designed to collect data and analyze it retrospectively on patients with cardiac amyloidosis who have been evaluated and treated at major amyloid centers across the US and internationally between 1997 and 2025.
Amyloidosis is a rare, multisystem disorder in which an insoluble protein is deposited in tissues, leading to organ dysfunction. Several proteins have been identified to potentially lead to amyloid cardiomyopathy (AC). Given the rare nature of these diseases, a large, multi-center effort to describe the characteristics of these patients and their outcomes with novel treatment modalities has not been established. (TBD) academic medical centers from the US and internationally will compile demographic, hemodynamic and organ-involvement data, as well as treatment strategies for AL and TTR amyloidosis.
This registry is an observational, multi-center study designed to collect data and analyze it retrospectively on patients with cardiac amyloidosis who have been evaluated and treated at major amyloid centers across the US and internationally between 1997 and 2025. It is expected that the total patient population will be approximately 5000 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL and TTR amyloidosis | immunoglobulin light chain amyloidosis (AL) and transthyretin amyloidosis (ATTR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Registry | Other | Observational, data collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantify disease severity at diagnosis, progression and survival in patients with cardiac amyloidosis | Clinical Outcomes: Disease severity at presentation, progression, and survival [time frame 3 years]. Severity and progression determined by change in NYHA Class, NT-ProBNP and troponin. | 1997 - 2025 |
| Quantify incidence of complications from cardiac amyloidosis | Determine incidence of arrhythmias (atrial fibrillation; ventricular arrhythmias) after diagnosis, renal dysfunction (rise in creatinine and development of end-stage renal disease), stroke, bleeding complications [time frame 3 years] | 1997 - 2025 |
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Inclusion Criteria:
Exclusion Criteria:
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Established diagnosis of AL or TTR cardiomyopathy identified or treated
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Sarver Heart Center | Tucson | Arizona | 85724 | United States | ||
| UC San Diego Health, Sulpizio Cardiovascular Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37907148 | Derived | Stern LK, Grodin JL, Maurer MS, Ruberg FL, Patel AR, Khouri MG, Roth LR, Aras MA, Bhardwaj A, Bhattacharya P, Brailovsky Y, Drachman BM, Ebong IA, Fine NM, Gaggin H, Gopal D, Griffin J, Judge D, Kim P, Mitchell J, Mitter SS, Mohan RC, Ramos H, Reyentovich A, Sheikh FH, Sperry B, Carter S, Urey M, Vaishnav J, Vest AR, Kittleson MM, Patel JK. The Cardiac Amyloidosis Registry Study (CARS): Rationale, Design and Methodology. J Card Fail. 2024 May;30(5):669-678. doi: 10.1016/j.cardfail.2023.09.016. Epub 2023 Oct 30. |
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The study design reflects IPD sharing between researchers based upon agrred set of data elements for study projects in the registry.
Data will become available upon entry of IPD into the data base and will remain available for the duration of the study.
Project participants will have access to IPD only relevant to their approved projects. project approval will be determined collectively by the PIs of all the participating sites.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 10, 2023 | Aug 23, 2023 |
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| La Jolla |
| California |
| 92037 |
| United States |
| Scripps Health | La Jolla | California | 92137 | United States |
| University of California Davis | Sacramento | California | 95817 | United States |
| University of California, San Francisco | San Francisco | California | 94103 | United States |
| MedStar Health and Vascular Institute/Georgetown University School of Medicine | Washington D.C. | District of Columbia | 20010 | United States |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Weill Cornell Medicine | New York | New York | 10021 | United States |
| The Mount Sinai Hospital | New York | New York | 10029 | United States |
| Columbia University Irving Medical Center, Clinical Cardiovascular Research Laboratory for the Elderly (CUMC/CCRLE) | New York | New York | 10032 | United States |
| Duke Health | Durham | North Carolina | 27710 | United States |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| Prot_002.pdf |
| ID | Term |
|---|---|
| D000075363 | Immunoglobulin Light-chain Amyloidosis |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010265 | Paraproteinemias |
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| ID | Term |
|---|---|
| D012042 | Registries |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D011996 | Records |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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