Cardiometabolic Risk in Cardiac Rehab
|ClinicalTrials.gov Identifier: NCT01985048|
Recruitment Status : Unknown
Verified February 2015 by Health Diagnostic Laboratory, Inc..
Recruitment status was: Active, not recruiting
First Posted : November 15, 2013
Last Update Posted : February 13, 2015
- 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.
- 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.
|Condition or disease|
|Coronary Artery Disease|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Cardiometabolic Risk in the Setting of Cardiac Rehabilitation|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||March 2015|
- Cardiometabolic biomarker risk factor [ Time Frame: Change from Baseline at 3 months ]
- Major adverse cardiovascular events [ Time Frame: one year ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985048
|United States, Pennsylvania|
|Holy Spirit Hospital and Health Center|
|Camp Hill, Pennsylvania, United States, 17011|
|Ephrata Community Hospital|
|Ephrata, Pennsylvania, United States, 17522|
|Lancaster Heart & Vascular Institution, Cardiac Rehab|
|Lancaster, Pennsylvania, United States, 17604|
|Principal Investigator:||Roddy P Canosa, DO, FACC|
|Principal Investigator:||Tina Davis, CRNP|
|Principal Investigator:||James C. Lightfoot, M.D.|