Aging, Geriatric Syndromes and Clonal Hematopoiesis
Washington University School of Medicine
2,000 participants
Mar 10, 2016
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria9
- 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.
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Interventions
-Baseline and no more frequently than every 6 months until death
* 10 items about daily functional status * Baseline and no more frequently than every 6 months until death
* 7 items about daily functional status * Baseline and no more frequently than every 6 months until death
* 1 item about daily functional status * Baseline and no more frequently than every 6 months until death
* 1 item about daily functional status * Baseline and no more frequently than every 6 months until death
* 13 items about comorbidity * Baseline and no more frequently than every 6 months until death
* 4 items about social activity * Baseline and no more frequently than every 6 months until death
* 2 items about nutrition * Baseline and no more frequently than every 6 months until death
-Baseline and no more frequently than every 6 months until death
* 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
* 7 items about heart health and smoking history * Baseline and no more frequently than every 6 months until death
* Research coordinator will test gait speed * Baseline and no more frequently than every 6 months until death
* Research coordinator will test grip strength * Baseline and no more frequently than every 6 months until death
-Baseline and no more frequently than every 6 months until death
-Baseline and no more frequently than every 6 months until death
-1 optional bone marrow biopsy
-For Arm E only
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02604563