Aging, Geriatric Syndromes and Clonal Hematopoiesis
In this study the investigators will incorporate a wide range of clinical variables associated with aging and cardiovascular disease to determine whether they are associated with mutation status independent of chronologic age. Clinically, aging can be operationalized using geriatric assessment, which entails a comprehensive multi-dimensional assessment of the health of an older adult, including measures of comorbidity, polypharmacy, functional status, cognition, depression, falls, social activities and social support. Given that aging is heterogeneous, geriatric assessment allows greater specificity for aging than chronological age alone.
Conditions:
🦠 Geriatrics 🦠 Aged 🦠 Geriatric Syndromes 🦠 Cardiovascular Diseases
🗓️ Study Start (Actual) 10 March 2016
🗓️ Primary Completion (Estimated) 30 April 2030
✅ Study Completion (Estimated) 30 April 2030
👥 Enrollment (Estimated) 2000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Saint Louis, Missouri, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * At least 50 years of age.
    • * Able to understand written and spoken English.
    • * Able to understand and willing to sign an IRB-approved written informed consent document (or that of a legally authorized representative, if applicable for the trauma cohort)

    Exclusion Criteria:

    • * Inability or unwillingness to complete health questionnaire.
    • * History of a recent (\<30 days) acute viral illness.
    • * Current cancer diagnosis and currently receiving chemotherapy or undergoing radiation therapy. A prior history of cancer is allowed if the participant completed therapy \> 1 year prior to enrollment; participants with a prior diagnosis of cancer will be asked to sign a release of information for the research team to obtain records regarding their prior cancer treatment.
    • * Current use of drugs that cause DNA damage (e.g. Cytoxan, azathioprine, etc.) for the treatment of a non-malignant disease.
    • * Vulnerable populations (e.g. prisoners).
    • * Known infection with Hepatitis B or C, HTLV, or HIV.
    • * Additional exclusion for optional bone marrow aspirate/biopsy substudy:
    • * Use of medications for anticoagulation or "blood thinning" including warfarin, low molecular weight heparins (enoxaparin, daltaparin) or direct-acting oral anticoagulants (dabigatran, rivaroxaban, apixaban, edoxaban or betrixaban)
    • * allergy to lidocaine or other local anesthetics.
Ages Eligible for Study: 50 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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 9 November 2015
  • First Submitted that Met QC Criteria 12 November 2015
  • First Posted 13 November 2015

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 April 2024
  • Last Update Posted 24 April 2024
  • Last Verified April 2024