Cardiometabolic Risk in Cardiac Rehab

• Conditions: Coronary Artery Disease

• Registration Number: NCT01985048
• Lead Sponsor: Health Diagnostic Laboratory, Inc.

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-08
• Study First Posted: 2013-11-15
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-12
• Last Update Posted: 2015-02-13
• Primary Completion: 2015-03
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Known CAD/ IHD

• Eligibility for cardiac rehab following an acute coronary event; either:

  • ST elevation myocardial infarction
  • Non ST elevation myocardial infarction
  • Angina
  • CABG

Exclusion Criteria

• Younger than 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiometabolic biomarker risk factor	Change from Baseline at 3 months

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	one year

Trial Locations

Locations (3)

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