Recruiting

Observational Study

Sponsor:

CirQuest Labs, LLC

Code:

NCT03551756

Conditions

Heart Failure With Reduced Ejection Fraction

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Biomarker Assessment

Study Details

Brief summary:

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

Conditions

Heart Failure With Reduced Ejection Fraction

Coronary Artery Disease

Study ID

NCT03551756

Start date

Jul 10, 2018

Status verified date

Jan, 2020

Completion date

Jul, 2020

Anticipated

Primary completion date

Jul, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Group 1: Heart Failure with Coronary Artery Disease Subjects

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

Group 2: Healthy Subjects

• Age 18 years or older at the first screening visit and 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

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Heart Failure & Coronary Artery Disease

Biomarker assessment in adults with decompensated heart failure and significant underlying coronary artery disease

Healthy Adult

Biomarker assessment in 20 healthy age-matched subjects

Interventions

Biomarker Assessment

Exploratory Biomarker Analysis for cardiac patients versus healthy adults

Primary outcome measure

  • Biomarker assessment [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Locations

University of Florida

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Principal Investigator:

Dominick J Angiolillo, MD

Stern Cardiovascular

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Principal Investigator:

Frank A McGrew, MD

CirQuest Labs, LLC

Recruiting

Memphis, Tennessee, United States, 38112

Contacts

Principal Investigator:

Lisa K Jennings, PhD

More Information

Sponsor

CirQuest Labs, LLC

Last update posted

Jan 23, 2020

Last verified

Jan, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CirQuest Labs, LLC on 2020-01-23.