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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
October 1, 2013
Primary Completion Date
March 1, 2015
Completion Date
March 1, 2015
Last Updated
February 13, 2015
500
ESTIMATED participants
Lead Sponsor
Health Diagnostic Laboratory, Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01311323