This trial is active, not recruiting.

Condition coronary artery disease
Sponsor Health Diagnostic Laboratory, Inc.
Start date October 2013
End date March 2015
Trial size 500 participants
Trial identifier NCT01985048, R2013-3102


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Cardiometabolic biomarker risk factor
time frame: Change from Baseline at 3 months

Secondary Outcomes

Major adverse cardiovascular events
time frame: one year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Cardiometabolic Risk in the Setting of Cardiac Rehabilitation
Principal investigator Roddy P Canosa, DO, FACC
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Health Diagnostic Laboratory, Inc..