Cardiometabolic Risk in Cardiac Rehab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
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.

Condition or disease
Coronary Artery Disease

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 Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Primary Outcome Measures :
  1. Cardiometabolic biomarker risk factor [ Time Frame: Change from Baseline at 3 months ]

Secondary Outcome Measures :
  1. Major adverse cardiovascular events [ Time Frame: one year ]

Biospecimen Retention:   Samples With DNA
Whole Blood and Serum

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Representative of the ethnic population of the areas served by the respective study sites.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its 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
Sponsors and Collaborators
Health Diagnostic Laboratory, Inc.
Principal Investigator: Roddy P Canosa, DO, FACC
Principal Investigator: Tina Davis, CRNP
Principal Investigator: James C. Lightfoot, M.D.


Responsible Party: Health Diagnostic Laboratory, Inc. Identifier: NCT01985048     History of Changes
Other Study ID Numbers: R2013-3102
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: February 13, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases