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Amyloidosis Incidence in High-Risk Cardiac Device Patients
This single-practice prospective cohort study aims to enhance the diagnosis of cardiac amyloidosis in high-risk patients undergoing standard cardiac device implantation. By analyzing chest wall fat tissue, which is usually discarded, we aim to determine the diagnostic yield of such biopsies for amyloidosis and to develop a predictive screening model based on clinical, lab, and imaging data. The study, running from December 2023 to December 2024, expects to enroll 100 patients and may provide a new, non-invasive diagnostic avenue for this condition.
Conditions:
🦠 Amyloid 🦠 Cardiac Amyloidosis 🦠 Amyloidosis Cardiac 🦠 Systemic Amyloidosis 🦠 AL Amyloidosis 🦠 Infiltrative Cardiomyopathy, Amyloid 🦠 ATTR Amyloidosis Wild Type
🗓️ Study Start (Actual) 29 January 2024
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 100
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Overland Park, Kansas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patients who are 40 years of age or older
    • * Patients who are able and willing to provide informed consent
    • * Patients who are scheduled for CIED implantation within the study period and with clinical lab and imaging features suggestive of cardiac amyloidosis

    Exclusion Criteria:

    • * Individuals below the age of 40.
    • * Persons who are unable to consent or who do not consent to participate.
    • * Patients who have already been diagnosed with cardiac amyloidosis prior to the study
Ages Eligible for Study: 40 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 December 2023
  • First Submitted that Met QC Criteria 16 December 2023
  • First Posted 29 December 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 February 2024
  • Last Update Posted 20 February 2024
  • Last Verified December 2023
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