Aging, Geriatric Syndromes and Clonal Hematopoiesis

Cardiovascular Diseases Clinical Trial

Official title:

Aging, Geriatric Syndromes and Clonal Hematopoiesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02604563
• Other study ID #: 201511019
• Status: Recruiting
• Start date: March 10, 2016
• Est. completion date: April 30, 2030

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: Meagan Jacoby, M.D.
• Phone: 314-747-8439
• Email: mjacoby[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: April 30, 2030
• Est. primary completion date: April 30, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aged
• Cardiovascular Diseases
• Geriatric Syndromes
• Geriatrics
• Syndrome

Intervention

Other:
• Cognitive Assessment
-Baseline and no more frequently than every 6 months until death
• Activities of Daily Living Questionnaire
10 items about daily functional status Baseline and no more frequently than every 6 months until death
• Instrumental 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
• Karnofsky Self-reported Performance Rating Scale
1 item about daily functional status Baseline and no more frequently than every 6 months until death
• Number of Falls
1 item about daily functional status Baseline and no more frequently than every 6 months until death
• Physical Health Section, subscale of the OARS
13 items about comorbidity Baseline and no more frequently than every 6 months until death
• MOS Social Activity Survey
4 items about social activity Baseline and no more frequently than every 6 months until death
• Unintentional Weight Loss
2 items about nutrition Baseline and no more frequently than every 6 months until death

Genetic:
• Peripheral Blood Draw
-Baseline and no more frequently than every 6 months until death
• Buccal 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

Other:
• Heart 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
• Gait Speed
Research coordinator will test gait speed Baseline and no more frequently than every 6 months until death
• Grip Strength
Research coordinator will test grip strength Baseline and no more frequently than every 6 months until death
• Height and Weight measurements
-Baseline and no more frequently than every 6 months until death
• Blood pressure measurement
-Baseline and no more frequently than every 6 months until death

Procedure:
• Optional bone marrow biopsy
-1 optional bone marrow biopsy
• Blood draw for trauma measurements
-For Arm E only

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Edward P. Evans Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	-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.	Estimated to be 10 years
Primary	Presence or absence of geriatric syndromes as measured by hematopoietic stem cell mutations	-The presence or absence of geriatric syndromes will be correlated with the mutation status of individuals.	Estimated to be 10 years
Primary	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	-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.	Estimated to be 10 years
Primary	Presence or absence of cardiovascular disease as measured by hematopoietic stem call mutations		Estimated to be 10 years
Primary	Determine whether expansion of clonal hematopoiesis (CH) occurs following acute trauma	-Measures change in variant allele fraction	Estimated to be 10 years

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine