Cardiometabolic Risk in Cardiac Rehab
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/8/2015 |
Start Date: | October 2013 |
End Date: | March 2015 |
Contact: | Stephen Varvel, PhD |
Email: | svarvel@hdlabinc.com |
Phone: | 877-443-5227 |
Cardiometabolic Risk in the Setting of Cardiac Rehabilitation
1. Primary Objectives:
- To characterize cardiometabolic risk factor profiles of patients entering cardiac
rehab using traditional approaches (eg LDL-C) as well as a more comprehensive
panel of cardiovascular and metabolic biomarkers. It is hypothesized that the
comprehensive panel will identify further increased risk that would not have been
detected using only traditional approaches. Specifically, it is hypothesized that
a greater percentage of the cohort will be identified with "high risk" levels of
LDL-P (>1100 nmol/L) and/or apoB (>80 mg/dL) than of LDL-C (>100 mg/dL). It is
further hypothesized that the prevalence of elevated Lp(a) and elevated levels of
inflammatory and insulin resistance markers will be higher in this cohort when
compared to population norms (HDL, inc reference data).
- To assess improvements in laboratory and lifestyle risk factors and rate of goal
attainment at completion of rehab (eg 3 months). This objective is primarily
descriptive, and improvements in traditional risk factors (eg LDL-C) will be
compared to existing published data. Improvements in non-traditional risk factors
(eg LDL-P, insulin resistance markers) in a cardiac rehab population have not been
extensively investigated.
- To determine which attributes at baseline best predicted recurrent events and
re-hospitalizations assessed one year later.
2. Secondary/Developmental Objective:
- To inform and guide development of a subsequent study protocol designed to compare
outcomes associated with biomarker-guided personalized treatment plans vs.
standard of care in the cardiac rehab setting.
- To characterize cardiometabolic risk factor profiles of patients entering cardiac
rehab using traditional approaches (eg LDL-C) as well as a more comprehensive
panel of cardiovascular and metabolic biomarkers. It is hypothesized that the
comprehensive panel will identify further increased risk that would not have been
detected using only traditional approaches. Specifically, it is hypothesized that
a greater percentage of the cohort will be identified with "high risk" levels of
LDL-P (>1100 nmol/L) and/or apoB (>80 mg/dL) than of LDL-C (>100 mg/dL). It is
further hypothesized that the prevalence of elevated Lp(a) and elevated levels of
inflammatory and insulin resistance markers will be higher in this cohort when
compared to population norms (HDL, inc reference data).
- To assess improvements in laboratory and lifestyle risk factors and rate of goal
attainment at completion of rehab (eg 3 months). This objective is primarily
descriptive, and improvements in traditional risk factors (eg LDL-C) will be
compared to existing published data. Improvements in non-traditional risk factors
(eg LDL-P, insulin resistance markers) in a cardiac rehab population have not been
extensively investigated.
- To determine which attributes at baseline best predicted recurrent events and
re-hospitalizations assessed one year later.
2. Secondary/Developmental Objective:
- To inform and guide development of a subsequent study protocol designed to compare
outcomes associated with biomarker-guided personalized treatment plans vs.
standard of care in the cardiac rehab setting.
This pilot study will characterize risk factors of patients as they enter cardiac rehab,
track how comprehensive biomarker profiles change during the normal course of rehab, and
associate biomarkers at baseline with MACE outcomes assessed one year later. Blood draws,
vitals, and patient medical histories will be collected as subjects enter rehab and at the
end of the rehab program. Major adverse cardiac events will be assessed via phone interview
at 12 months.
track how comprehensive biomarker profiles change during the normal course of rehab, and
associate biomarkers at baseline with MACE outcomes assessed one year later. Blood draws,
vitals, and patient medical histories will be collected as subjects enter rehab and at the
end of the rehab program. Major adverse cardiac events will be assessed via phone interview
at 12 months.
Inclusion Criteria:
- Known CAD/ IHD
- Eligibility for cardiac rehab following an acute coronary event; either:
- ST elevation myocardial infarction
- Non ST elevation myocardial infarction
- Angina
- CABG
Exclusion Criteria:
- Younger than 18 years old
We found this trial at
3
sites
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