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Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease

September 11, 2019

Overview

The Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease trial compares biomarker levels in patients with heart failure and CAD with healthy control subjects.

 

Study Information

This is an observational study of 120 participants. Subjects won’t get a therapeutic treatment in the study but will have their blood drawn.

 

Inclusion Criteria

Group 1: Heart Failure with Coronary Artery Disease Subjects

  • Age 18+ at first screening visit
  • Symptomatic heart failure (≥ 3 months) with most recently documented LVEF ≤ 40% (Echo must have been completed in the last 12 months prior to enrollment.)
  • Significant underlying coronary artery disease as evidenced by:
  • Patients with previous myocardial infarction
  • Patients with prior coronary artery bypass graft
  • Patients with 50% coronary stenosis of one or more arteries and/or
  • Patients with a history of percutaneous coronary intervention with or without stenting

 

Group 2: Healthy Subjects

  • Age 18+ at first screening visit
  • Within 20% of mean age of Group 1 subjects

 

Exclusion Criteria

Group 1:

  • Documented history of “severe” valvular disease
  • Documented history of atrial fibrillation, ventricular fibrillation or ventricular tachycardia.
  • Recent or current use of anticoagulant medications such as fXa inhibitors, direct thrombin inhibitors, vitamin K antagonists, or heparin. (within 1 month of screening)

 

Group 2:

  • Known significant cardiovascular or hematological condition
  • Recent or current use of anticoagulant medications such as fXa inhibitors, direct thrombin inhibitors, vitamin K antagonists, or heparin. (within 1 month of screening)
  • Recent cold or flu symptoms, respiratory infection or surgery (within 2 weeks of screening)
  • History of Asthma
  • History of peptic ulcers

 

Location

CirQuest Labs, LLC

Memphis, Tennessee, United States, 38112

Contact: Carol E Hendrix, MSN, RN    901-866-1700 chendrix@cirquestlabs.com

Contact: Edward Hord, BSN, RN    901-866-1700 ehord@cirquestlabs.com  

Principal Investigator: Lisa K Jennings, PhD        

Sub-Investigator: Rick Alleman, PhD    

 

Collaborators/Sponsors

CirQuest Labs, LLC

Janssen Scientific Affairs, LLC

Principal Investigator: Lisa K. Jennings, PhD CirQuest Labs, LLC

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