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

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ClinicalTrials.gov Identifier: NCT03551756
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : January 23, 2020
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
CirQuest Labs, LLC

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

Condition or disease Intervention/treatment
Heart Failure With Reduced Ejection Fraction Coronary Artery Disease Other: Biomarker Assessment

Detailed Description:
This is a cross-sectional, single center exploratory study of plasma biomarker levels in adults with decompensated heart failure and significant underlying coronary artery disease as compared with age-matched healthy controls. Subjects will not receive a therapeutic treatment as part of this study and will undergo a single blood draw.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Heart Failure & Coronary Artery Disease
Biomarker assessment in adults with decompensated heart failure and significant underlying coronary artery disease
Other: Biomarker Assessment
Exploratory Biomarker Analysis for cardiac patients versus healthy adults

Healthy Adult
Biomarker assessment in 20 healthy age-matched subjects
Other: Biomarker Assessment
Exploratory Biomarker Analysis for cardiac patients versus healthy adults




Primary Outcome Measures :
  1. Biomarker assessment [ Time Frame: 1 day ]
    Exploratory biomarker analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
100 subjects with the study diagnosis and 20 healthy age-matched subjects, no restrictions on gender, race, or ethnicity
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT03551756


Contacts
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Contact: Carol E Hendrix, MSN, RN 901-866-1700 chendrix@cirquestlabs.com
Contact: Edward Hord, BSN, RN 901-866-1700 ehord@cirquestlabs.com

Locations
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United States, Florida
University of Florida Recruiting
Jacksonville, Florida, United States, 32209
Contact: Latonya Been    904-244-4520    Latonya.Been@jax.ufl.edu   
Principal Investigator: Dominick J Angiolillo, MD         
United States, Tennessee
Stern Cardiovascular Recruiting
Germantown, Tennessee, United States, 38138
Contact: Brian Dragutsky    901-271-1000    brian.dragutsky@sterncardio.com   
Contact: Rishi Bhula    901-271-1000    rishi.bhula@sterncardio.com   
Principal Investigator: Frank A McGrew, MD         
CirQuest Labs, LLC Recruiting
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         
Sponsors and Collaborators
CirQuest Labs, LLC
Janssen Scientific Affairs, LLC
Investigators
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Principal Investigator: Lisa K. Jennings, PhD CirQuest Labs, LLC
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Responsible Party: CirQuest Labs, LLC
ClinicalTrials.gov Identifier: NCT03551756    
Other Study ID Numbers: CQ 17-11-009
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases