Cardiometabolic Risk in Cardiac Rehab
Status unconfirmed
Conditions studied: Coronary Artery Disease
In brief
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.
Key facts
- Study ID
- NCT01985048
- Run by
- Health Diagnostic Laboratory, Inc.
- People needed
- 500
- Starts
- 2013-10-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2015-02-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Known CAD/ IHD
- Eligibility for cardiac rehab following an acute coronary event; either:
- ST elevation myocardial infarction
- Non ST elevation myocardial infarction
- Angina
- CABG
You may not qualify if…
- Younger than 18 years old
Where it is running
- Holy Spirit Hospital and Health Center — Camp Hill, Pennsylvania, United States
- Ephrata Community Hospital — Ephrata, Pennsylvania, United States
- Lancaster Heart & Vascular Institution, Cardiac Rehab — Lancaster, Pennsylvania, United States
Full record on ClinicalTrials.gov
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