- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03551756
Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease
January 22, 2020 updated by: CirQuest Labs, LLC
Assessment of Biomarkers in Patients with Decompensated Heart Failure and Underlying Coronary Artery Disease
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carol E Hendrix, MSN, RN
- Phone Number: 901-866-1700
- Email: chendrix@cirquestlabs.com
Study Contact Backup
- Name: Edward Hord, BSN, RN
- Phone Number: 901-866-1700
- Email: ehord@cirquestlabs.com
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32209
- Recruiting
- University of Florida
-
Contact:
- Latonya Been
- Phone Number: 904-244-4520
- Email: Latonya.Been@jax.ufl.edu
-
Principal Investigator:
- Dominick J Angiolillo, MD
-
-
Tennessee
-
Germantown, Tennessee, United States, 38138
- Recruiting
- Stern Cardiovascular
-
Contact:
- Brian Dragutsky
- Phone Number: 901-271-1000
- Email: brian.dragutsky@sterncardio.com
-
Contact:
- Rishi Bhula
- Phone Number: 901-271-1000
- Email: rishi.bhula@sterncardio.com
-
Principal Investigator:
- Frank A McGrew, MD
-
Memphis, Tennessee, United States, 38112
- Recruiting
- CirQuest Labs, LLC
-
Contact:
- Carol E Hendrix, MSN, RN
- Phone Number: 901-866-1700
- Email: chendrix@cirquestlabs.com
-
Contact:
- Edward Hord, BSN, RN
- Phone Number: 901-866-1700
- Email: ehord@cirquestlabs.com
-
Principal Investigator:
- Lisa K Jennings, PhD
-
Sub-Investigator:
- Rick Alleman, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Heart Failure & Coronary Artery Disease
Biomarker assessment in adults with decompensated heart failure and significant underlying coronary artery disease
|
Exploratory Biomarker Analysis for cardiac patients versus healthy adults
|
Healthy Adult
Biomarker assessment in 20 healthy age-matched subjects
|
Exploratory Biomarker Analysis for cardiac patients versus healthy adults
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biomarker assessment
Time Frame: 1 day
|
Exploratory biomarker analysis
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lisa K. Jennings, PhD, CirQuest Labs, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 10, 2018
Primary Completion (Anticipated)
July 1, 2020
Study Completion (Anticipated)
July 1, 2020
Study Registration Dates
First Submitted
May 29, 2018
First Submitted That Met QC Criteria
May 29, 2018
First Posted (Actual)
June 11, 2018
Study Record Updates
Last Update Posted (Actual)
January 23, 2020
Last Update Submitted That Met QC Criteria
January 22, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CQ 17-11-009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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