Cardiometabolic Risk in Cardiac Rehab
- 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.
Coronary Artery Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Cardiometabolic Risk in the Setting of Cardiac Rehabilitation|
- Cardiometabolic biomarker risk factor [ Time Frame: Change from Baseline at 3 months ] [ Designated as safety issue: No ]
- Major adverse cardiovascular events [ Time Frame: one year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole Blood and Serum
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01985048
|Contact: Stephen Varvel, PhD||877-443-5227 ext email@example.com|
|Contact: Monique Alston, LPN||877-443-5227 ext firstname.lastname@example.org|
|United States, Pennsylvania|
|Holy Spirit Hospital and Health Center||Recruiting|
|Camp Hill, Pennsylvania, United States, 17011|
|Contact: Kathy Thumma, RN,BSN,NE-BC 717-972-4486 email@example.com|
|Principal Investigator: James C. Lightfoot, MD|
|Ephrata Community Hospital||Recruiting|
|Ephrata, Pennsylvania, United States, 17522|
|Contact: Elise Hartranft, MSN, CRNP firstname.lastname@example.org|
|Contact: Cindy Kolp 717-738-6121 email@example.com|
|Principal Investigator: Roddy P Canosa, D.O., F.A.CC|
|Lancaster Heart & Vascular Institution, Cardiac Rehab||Recruiting|
|Lancaster, Pennsylvania, United States, 17604|
|Contact: Heidi Testa, RN, BSN 717-544-1777 firstname.lastname@example.org|
|Principal Investigator: Tina Davis, CRNP|
|Principal Investigator:||Roddy P Canosa, DO, FACC|
|Principal Investigator:||Tina Davis, CRNP|
|Principal Investigator:||James C. Lightfoot, M.D.|