Aging, Geriatric Syndromes and Clonal Hematopoiesis

The Washington University

Status: Enrolling

Conditions: Geriatric Syndromes; Geriatrics; Cardiovascular Diseases; Aged

Treatments: Other: Activities of Daily Living Questionnaire; Other: Height and Weight measurements; Other: Instrumental Activities of Daily Living, subscale of the OARS; Other: Unintentional Weight Loss; Other: Gait Speed; Genetic: Buccal Swab; Other: Cognitive Assessment; Other: Grip Strength; Other: Physical Health Section, subscale of the OARS; Other: Heart Health and Smoking History from BRFSS questionnaire; Procedure: Optional bone marrow biopsy; Other: Number of Falls; Other: Karnofsky Self-reported Performance Rating Scale; Procedure: Blood draw for trauma measurements; Other: Blood pressure measurement; Genetic: Peripheral Blood Draw; Other: MOS Social Activity Survey

Study type: Observational

Funder types: Other

Identifiers

NCT02604563

201511019

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

2,000 participants in 5 patient groups

Arm A: Clonal hematopoiesis

Description:

* Complete several self-administered health assessments at baseline and every 6 months until death. * Cognitive assessment, Gait Speed, grip strength, blood pressure, height, and weight will be performed by a member of the research team at baseline and every 6 months until death. * Peripheral blood draw will occur at baseline and no more than every 6 months until death. * Buccal swabs will occur at baseline and repeated as necessary, but not more than every 6 months until death * May be approached about optional bone marrow biopsy

Treatment:

Other: MOS Social Activity Survey

Genetic: Peripheral Blood Draw

Other: Blood pressure measurement

Other: Karnofsky Self-reported Performance Rating Scale

Other: Number of Falls

Procedure: Optional bone marrow biopsy

Other: Heart Health and Smoking History from BRFSS questionnaire

Other: Physical Health Section, subscale of the OARS

Other: Grip Strength

Other: Cognitive Assessment

Genetic: Buccal Swab

Other: Gait Speed

Other: Unintentional Weight Loss

Other: Height and Weight measurements

Other: Instrumental Activities of Daily Living, subscale of the OARS

Other: Activities of Daily Living Questionnaire

Arm B: No clonal hematopoiesis

Description:

* Complete several self-administered health assessments at baseline and every 6 months until death. * Cognitive assessment, Gait Speed, grip strength, blood pressure, height, and weight will be performed by a member of the research team at baseline and every 6 months until death. * Peripheral blood draw will occur at baseline and no more than every 6 months until death. * Buccal swabs will occur at baseline and repeated as necessary, but not more than every 6 months until death * May be approached about optional bone marrow biopsy

Treatment:

Other: MOS Social Activity Survey

Genetic: Peripheral Blood Draw

Other: Blood pressure measurement

Other: Karnofsky Self-reported Performance Rating Scale

Other: Number of Falls

Procedure: Optional bone marrow biopsy

Other: Heart Health and Smoking History from BRFSS questionnaire

Other: Physical Health Section, subscale of the OARS

Other: Grip Strength

Other: Cognitive Assessment

Genetic: Buccal Swab

Other: Gait Speed

Other: Unintentional Weight Loss

Other: Height and Weight measurements

Other: Instrumental Activities of Daily Living, subscale of the OARS

Other: Activities of Daily Living Questionnaire

Arm C: No clonal hematopoiesis & no follow-up

Description:

* Complete several self-administered health assessments at baseline with no further follow-up * Cognitive assessment, Gait Speed, grip strength, blood pressure, height, and weight will be performed by a member of the research team at baseline with no further follow-up * Peripheral blood draw will occur at baseline with no further follow-up * Buccal swabs will occur at baseline with no further follow-up

Treatment:

Other: MOS Social Activity Survey

Genetic: Peripheral Blood Draw

Other: Blood pressure measurement

Other: Karnofsky Self-reported Performance Rating Scale

Other: Number of Falls

Other: Heart Health and Smoking History from BRFSS questionnaire

Other: Physical Health Section, subscale of the OARS

Other: Grip Strength

Other: Cognitive Assessment

Genetic: Buccal Swab

Other: Gait Speed

Other: Unintentional Weight Loss

Other: Height and Weight measurements

Other: Instrumental Activities of Daily Living, subscale of the OARS

Other: Activities of Daily Living Questionnaire

Arm D: Hip replacement

Description:

* Complete several self-administered health assessments at baseline and every 6 months until death. * Cognitive assessment, Gait Speed, grip strength, blood pressure, height, and weight will be performed by a member of the research team at baseline and every 6 months until death. * Participants with or without clonal hematopoiesis who are undergoing hip replacement * Peripheral blood draw will occur at baseline and no more than every 6 months until death. * Buccal swabs will occur at baseline and repeated as necessary, but not more than every 6 months until death * May be approached about optional bone marrow biopsy

Arm E: Trauma

Description:

-Blood sample at the time of admission with initial bloodwork. For inpatient participants, weekly follow-up samples will be drawn with morning phlebotomy. A follow-up sample collection will occur 4-7 weeks after discharge.

Treatment:

Procedure: Blood draw for trauma measurements