Cardiovascular Health Program Registry
| Status: | Terminated |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/4/2019 |
| Start Date: | December 2014 |
| End Date: | August 24, 2017 |
The purpose of this study is to establish a registry that uses observational study methods to
collect uniform data (clinical, lifestyle and other) to evaluate specific outcomes and to
enable research on patients at risk for cardiovascular disease (CVD).
This is a descriptive, observational registry study. All data for participants in the WRNMMC
Integrative Cardiac Health Project (ICHP) Cardiovascular Health Program (CHP) will be entered
into a single, secure information management system (IMS) for subjects at risk for CVD. At
periodical intervals, the IMS will be queried to define the effect of an integrative
therapeutic lifestyle change (TLC) program on CVD risk over time. This protocol outlines
collection, storage, and handling of data, describes specific data elements and lays the
foundation for future research questions.
collect uniform data (clinical, lifestyle and other) to evaluate specific outcomes and to
enable research on patients at risk for cardiovascular disease (CVD).
This is a descriptive, observational registry study. All data for participants in the WRNMMC
Integrative Cardiac Health Project (ICHP) Cardiovascular Health Program (CHP) will be entered
into a single, secure information management system (IMS) for subjects at risk for CVD. At
periodical intervals, the IMS will be queried to define the effect of an integrative
therapeutic lifestyle change (TLC) program on CVD risk over time. This protocol outlines
collection, storage, and handling of data, describes specific data elements and lays the
foundation for future research questions.
The CHP registry consists of uniform data to evaluate the outcomes of military beneficiaries
at CVD risk. These uniform data include variables (clinical, lifestyle, traditional,
non-traditional, objective and subjective) that are used to assess a CVD risk profile and the
effects of TLC. All data are collected in the course of the clinical CHP.
Data are comprised of demographic information; past and intercurrent medical history
including risk factors of CVD such as coronary artery disease (CAD), carotid disease,
peripheral arterial disease, aortic aneurysm hypertension, diabetes and sleep apnea; smoking,
alcohol and drug use history; family history of CVD and other chronic diseases; deployment
history, injuries and occupational exposures; mental health history including PTSD,
depression and anxiety; lifestyle information comprised of self-reported dietary patterns,
exercise activities, stress levels, and sleep habits; physical examination including vital
signs, body mass index, waist circumference and per cent body fat; laboratory data routinely
requested by the CHP for risk assessment of all patients entering the program is comprised of
total cholesterol, cholesterol fractions, fasting glucose, fasting insulin, hemoglobin A1C,
highly sensitive C-reactive protein, and vitamin D levels; and CV diagnostic tests such as
EKG, echocardiogram, cardiac stress testing; and sleep testing.
Data are measured at baseline (CHP enrollment), completion of onsite CHP (6 months) and after
follow-up of the telephonic coaching phase (approximately 1 year). Data may also be collected
annually for up to 5 years if available.
at CVD risk. These uniform data include variables (clinical, lifestyle, traditional,
non-traditional, objective and subjective) that are used to assess a CVD risk profile and the
effects of TLC. All data are collected in the course of the clinical CHP.
Data are comprised of demographic information; past and intercurrent medical history
including risk factors of CVD such as coronary artery disease (CAD), carotid disease,
peripheral arterial disease, aortic aneurysm hypertension, diabetes and sleep apnea; smoking,
alcohol and drug use history; family history of CVD and other chronic diseases; deployment
history, injuries and occupational exposures; mental health history including PTSD,
depression and anxiety; lifestyle information comprised of self-reported dietary patterns,
exercise activities, stress levels, and sleep habits; physical examination including vital
signs, body mass index, waist circumference and per cent body fat; laboratory data routinely
requested by the CHP for risk assessment of all patients entering the program is comprised of
total cholesterol, cholesterol fractions, fasting glucose, fasting insulin, hemoglobin A1C,
highly sensitive C-reactive protein, and vitamin D levels; and CV diagnostic tests such as
EKG, echocardiogram, cardiac stress testing; and sleep testing.
Data are measured at baseline (CHP enrollment), completion of onsite CHP (6 months) and after
follow-up of the telephonic coaching phase (approximately 1 year). Data may also be collected
annually for up to 5 years if available.
Inclusion Criteria:
1. Any adult military, DEERS eligible, beneficiary who is participating in the CHP.
2. Subjects who present to the CHP for evaluation and participation may be self-referred
or be referred by a provider.
3. Must have working email address and access to the internet.
4. Participants elect to enroll in order to learn about healthy lifestyle choices that
can help prevent the development of cardiovascular disease.
Exclusion Criteria:
1. Less than 18 years of age.
2. Individuals unable or unwilling to participate or give informed consent will be
excluded from registry enrollment.
3. Subjects who were part of the retrospective CHP cohort cannot be enrolled in the
prospective study.
We found this trial at
1
site
Bethesda, Maryland 20889
Principal Investigator: Marina N Vernalis, DO
Phone: 301-400-1107
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