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Cardiometabolic Risk in Cardiac Rehab

NCT01985048 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2015-02-13

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Health Diagnostic Laboratory, Inc.

    lead INDUSTRY

Principal Investigators

  • Roddy P Canosa, DO, FACC

  • Tina Davis, CRNP

  • James C. Lightfoot, M.D.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01985048 on ClinicalTrials.gov