Cardiometabolic Risk in Cardiac Rehab

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Health Diagnostic Laboratory, Inc.
Sponsor:
Information provided by (Responsible Party):
Health Diagnostic Laboratory, Inc.
ClinicalTrials.gov Identifier:
NCT01985048
First received: November 5, 2013
Last updated: August 18, 2014
Last verified: August 2014
  Purpose
  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
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiometabolic Risk in the Setting of Cardiac Rehabilitation

Resource links provided by NLM:


Further study details as provided by Health Diagnostic Laboratory, Inc.:

Primary Outcome Measures:
  • Cardiometabolic biomarker risk factor [ Time Frame: Change from Baseline at 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major adverse cardiovascular events [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole Blood and Serum


Estimated Enrollment: 500
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01985048

Contacts
Contact: Stephen Varvel, PhD 877-443-5227 ext 2231 svarvel@hdlabinc.com
Contact: Monique Alston, LPN 877-443-5227 ext 2210 malston@hdlabinc.com

Locations
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    kathy.thumma@hsh.org   
Principal Investigator: James C. Lightfoot, MD         
Ephrata Community Hospital Recruiting
Ephrata, Pennsylvania, United States, 17522
Contact: Elise Hartranft, MSN, CRNP       eliseh@hslcares.com   
Contact: Cindy Kolp    717-738-6121    cindykolp@ephratahospital.org   
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    hltesta@lghealth.org   
Principal Investigator: Tina Davis, CRNP         
Sponsors and Collaborators
Health Diagnostic Laboratory, Inc.
Investigators
Principal Investigator: Roddy P Canosa, DO, FACC
Principal Investigator: Tina Davis, CRNP
Principal Investigator: James C. Lightfoot, M.D.
  More Information

Publications:

Responsible Party: Health Diagnostic Laboratory, Inc.
ClinicalTrials.gov Identifier: NCT01985048     History of Changes
Other Study ID Numbers: R2013-3102
Study First Received: November 5, 2013
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 21, 2014