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出境医 / 临床实验 / Cardiac Amyloidosis Registry Study (CARS)

Cardiac Amyloidosis Registry Study (CARS)

Study Description
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.

Condition or disease Intervention/treatment
Amyloidosis, Immunoglobulin Light-chain Other: Registry

Detailed Description:

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 2000 patients.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cardiac Amyloidosis Registry Study - A Multi-Center, Longitudinal, Observational Survey of Patients With Cardiac Amyloidosis
Actual Study Start Date : January 8, 2020
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025
Arms and Interventions
Group/Cohort Intervention/treatment
AL and TTR amyloidosis
immunoglobulin light chain amyloidosis (AL) and transthyretin amyloidosis (ATTR)
 Other: Registry
Observational, data collection
Outcome Measures
Primary Outcome Measures :
  1. Increase Understanding for AL and TTR Cardiac amyloid [ Time Frame: 1997 - 2025 ]
    Increase understanding of disease prevalence, presentation, progression, and various treatment plans for AL and TTR cardiac amyloid through study of a large cohort of patients with AL and TTR amyloidosis.

  2. Identify Characteristics [ Time Frame: 1997 - 2025 ]
    Identify demographic, hemodynamic, and organ-involvement data that are predictors of long-term survival.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Established diagnosis of AL or TTR cardiomyopathy identified or treated
Criteria

Inclusion Criteria:

  • 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.
  • Other sites: information on deceased individuals may be included, but only with the appropriate approval from the site IRB and/or according to the federal regulations for the protection of human subjects.

Exclusion Criteria:

  • 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.
Contacts and Locations

Locations
Layout table for location information
United States, Arizona
University of Arizona Sarver Heart Center
Tucson, Arizona, United States, 85724
United States, California
University of California Davis
Sacramento, California, United States, 95817
University of California, San Francisco
San Francisco, California, United States, 94103
United States, Missouri
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
United States, New York
Columbia University Irving Medical Center, Clinical Cardiovascular Research Laboratory for the Elderly (CUMC/CCRLE)
New York, New York, United States, 10032
United States, North Carolina
Duke Health
Durham, North Carolina, United States, 27710
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cedars-Sinai Medical Center
Tracking Information
First Submitted Date December 13, 2021
First Posted Date December 30, 2021
Last Update Posted Date December 30, 2021
Actual Study Start Date January 8, 2020
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 13, 2021)
  • Increase Understanding for AL and TTR Cardiac amyloid [ Time Frame: 1997 - 2025 ]
    Increase understanding of disease prevalence, presentation, progression, and various treatment plans for AL and TTR cardiac amyloid through study of a large cohort of patients with AL and TTR amyloidosis.
  • Identify Characteristics [ Time Frame: 1997 - 2025 ]
    Identify demographic, hemodynamic, and organ-involvement data that are predictors of long-term survival.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardiac Amyloidosis Registry Study
Official Title Cardiac Amyloidosis Registry Study - A Multi-Center, Longitudinal, Observational Survey of Patients With Cardiac Amyloidosis
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.
Detailed Description

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 2000 patients.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Established diagnosis of AL or TTR cardiomyopathy identified or treated
Condition Amyloidosis, Immunoglobulin Light-chain
Intervention Other: Registry
Observational, data collection
Study Groups/Cohorts AL and TTR amyloidosis
immunoglobulin light chain amyloidosis (AL) and transthyretin amyloidosis (ATTR)
Intervention: Other: Registry
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: December 13, 2021) 		2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.
  • Other sites: information on deceased individuals may be included, but only with the appropriate approval from the site IRB and/or according to the federal regulations for the protection of human subjects.

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05174338
Other Study ID Numbers STUDY00000442
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: The study design reflects IPD sharing between researchers based upon agrred set of data elements for study projects in the registry.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (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.
Responsible Party Jignesh Patel, MD, PhD, Cedars-Sinai Medical Center
Study Sponsor Cedars-Sinai Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Cedars-Sinai Medical Center
Verification Date December 2021