Geriatrics, Aged, Geriatric Syndromes, Cardiovascular Diseases
Conditions
Brief summary
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.
Interventions
OTHERCognitive Assessment
-Baseline and no more frequently than every 6 months until death
OTHERActivities of Daily Living Questionnaire
* 10 items about daily functional status * Baseline and no more frequently than every 6 months until death
OTHERInstrumental Activities of Daily Living, subscale of the OARS
* 7 items about daily functional status * Baseline and no more frequently than every 6 months until death
OTHERKarnofsky Self-reported Performance Rating Scale
* 1 item about daily functional status * Baseline and no more frequently than every 6 months until death
OTHERNumber of Falls
* 1 item about daily functional status * Baseline and no more frequently than every 6 months until death
OTHERPhysical Health Section, subscale of the OARS
* 13 items about comorbidity * Baseline and no more frequently than every 6 months until death
OTHERMOS Social Activity Survey
* 4 items about social activity * Baseline and no more frequently than every 6 months until death
OTHERUnintentional Weight Loss
* 2 items about nutrition * Baseline and no more frequently than every 6 months until death
GENETICPeripheral Blood Draw
-Baseline and no more frequently than every 6 months until death
GENETICBuccal Swab
* Participants will rinse their mouths 2 times with water for 20-30 seconds and discard the expectorated sample. One side of the inner cheek (buccal mucosa) will then be scraped with a cotton swab 20 times (alternatively, the tongue will be brushed 20 times with a toothbrush) * Baseline and no more frequently than every 6 months until death
OTHERHeart Health and Smoking History from BRFSS questionnaire
* 7 items about heart health and smoking history * Baseline and no more frequently than every 6 months until death
OTHERGait Speed
* Research coordinator will test gait speed * Baseline and no more frequently than every 6 months until death
OTHERGrip Strength
* Research coordinator will test grip strength * Baseline and no more frequently than every 6 months until death
OTHERHeight and Weight measurements
-Baseline and no more frequently than every 6 months until death
OTHERBlood pressure measurement
-Baseline and no more frequently than every 6 months until death
PROCEDUREOptional bone marrow biopsy
-1 optional bone marrow biopsy
PROCEDUREBlood draw for trauma measurements
-For Arm E only
Sponsors
Edward P. Evans Foundation
Washington University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the natural history of mutations in older adults with clonal hematopoiesis as measured by risk to develop blood cancer/geriatric syndrome/illness/cardiovascular disease | Estimated to be 10 years | -Individuals with mutations will be followed longitudinally to monitor the fraction of hematopoietic cells with mutations, the functional consequences of mutations in their blood cells, and the risk of developing a blood cancer, geriatric syndrome, cardiovascular disease, or other illness. |
| Background mutation rate in hematopoietic stem cells from older adults regardless of a prior cancer diagnosis as measured by the number and frequency of hematopoietic-specific mutations | Estimated to be 10 years | -The investigators will sequence the coding region of some or all of the genes in an individual's blood cells and compare results to their matched mouth cells to define hematopoietic-specific mutations. The number of hematopoietic-specific mutations per individual and the frequency of individuals with mutations will be measured. |
| Presence or absence of geriatric syndromes as measured by hematopoietic stem cell mutations | Estimated to be 10 years | -The presence or absence of geriatric syndromes will be correlated with the mutation status of individuals. |
| Presence or absence of cardiovascular disease as measured by hematopoietic stem call mutations | Estimated to be 10 years | — |
| Determine whether expansion of clonal hematopoiesis (CH) occurs following acute trauma | Estimated to be 10 years | -Measures change in variant allele fraction |
Countries
United States
Contacts
Primary ContactMeagan Jacoby, M.D.
Backup ContactKristina Williams, B.S.
Outcome results
None listed