Cardiac Amyloidosis Registry Study
CARS
1 other identifier
observational
5,000
2 countries
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Longer than P75 for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 8, 2020
CompletedFirst Submitted
Initial submission to the registry
December 13, 2021
CompletedFirst Posted
Study publicly available on registry
December 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedSeptember 6, 2023
September 1, 2023
5.9 years
December 13, 2021
September 1, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
AL and TTR amyloidosis
immunoglobulin light chain amyloidosis (AL) and transthyretin amyloidosis (ATTR)
Interventions
Eligibility Criteria
Established diagnosis of AL or TTR cardiomyopathy identified or treated
You may qualify if:
- Established diagnosis of AL or TTR cardiomyopathy identified or treated within the timeframe
- Specific to CSMC: If the individual provided consent while they were alive, and if sufficient information exists in their chart, their data will be included.
- Information on deceased individuals may be included, but only with the appropriate approval from the external site IRB and/or according to the federal regulations for the protection of human subjects.
You may not qualify if:
- At Cedars-Sinai, records that specifically state not to be used in research will not be accessed. Patients who have enacted a No Research Flag or are noted as "Break the Glass" will not be included. For external sites, records that indicate No Research Flag or are noted as "Break the Glass" may be included based on institutional policies and appropriate approvals, as applicable.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
University of Arizona Sarver Heart Center
Tucson, Arizona, 85724, United States
UC San Diego Health, Sulpizio Cardiovascular Center
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 13, 2021
First Posted
December 30, 2021
Study Start
January 8, 2020
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
September 6, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will become available upon entry of IPD into the data base and will remain available for the duration of the study.
- Access Criteria
- 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.
The study design reflects IPD sharing between researchers based upon agrred set of data elements for study projects in the registry.