RECRUITING

The CoAGulation Biomarkers and Atrial Fibrillation (COAG-AF) Pilot Study

Conditions

Atrial Fibrillation Catheter ablation Coagulation Atrial Fibrillation burden

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The aim of the Correlation Of CoAGulation-Atrial Fibrillation (COAG-AF) study is to prove that an increase in pro-thrombotic biomarkers in AF is associated with an increase in AF burden. Secondary objectives of the study are the following: * To investigate the impact of catheter ablation on serum pro-thrombotic biomarkers in patients with AF. * To correlate coagulation biomarkers with imaging features such as, the degree of fibrosis found on Late Gadolinium Enhancement Magnetic Resonance Imaging (LGE-MRI) scans, which is a part of standard of care. * To determine baseline values of coagulation and pro-thrombotic biomarkers in the AF population and compare those baseline values with the general population values. * To compare central and peripheral thrombotic biomarkers in patients with atrial fibrillation.

Official Title

Correlation Of CoAGulation Biomarkers and Atrial Fibrillation Burden in Patients Post Catheter Ablation: the COAG-AF Pilot Study

Quick Facts

Study Start:2021-09-22

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04947657

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.

Ages Eligible for Study:18 Years to 120 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients, male or female and older than 18 years of age. * Patients diagnosed with persistent or paroxysmal AF. * Patients that are undergoing catheter ablation at Tulane University Medical Center. * Patients that had a cardiac MRI prescribed by their physician as part of their standard of care.	* Patients with coagulation disorders such as, von Willebrand disease, hemophilia, Immune Thrombocytopenic Purpura, etc. * Patients who are pregnant or breast-feeding or plan to become pregnant during the study period. * Are not surgically sterile. * Are of childbearing potential and are unwilling to practice two acceptable methods of birth control. * Do not plan to continue practicing two acceptable methods of birth control throughout the trial (highly effective methods of birth control are defined as those, used alone or in combination, that result in a low failure rate i.e. less than 1% per year when used consistently and correctly). * Patients with mental and/or physical ailments which may prohibit them from actively participating in the study. * Any health-related gadolinium/MRI contraindications (e.g. allergy to gadolinium, pacemakers, Implantable Cardioverter Defibrillators (ICD's), other devices/implants contraindicated for use of MRI, etc.) * Patients who have a known terminal illness with a prognosis less than 12 months at the time of the informed consent process. * Planned cardiovascular intervention. * Patient with diagnosed acute or chronic severe kidney disease or with a low glomerular filtration rate (GFR), \<30 mL per minute per 1.73 m2 * Patients who cannot read, speak, and/or understand English. * Patients with cognitive impairments who are unable to give informed consent.

Inclusion Criteria

Exclusion Criteria

* Patients, male or female and older than 18 years of age.
* Patients diagnosed with persistent or paroxysmal AF.
* Patients that are undergoing catheter ablation at Tulane University Medical Center.
* Patients that had a cardiac MRI prescribed by their physician as part of their standard of care.

* Patients with coagulation disorders such as, von Willebrand disease, hemophilia, Immune Thrombocytopenic Purpura, etc.
* Patients who are pregnant or breast-feeding or plan to become pregnant during the study period.
* Are not surgically sterile.
* Are of childbearing potential and are unwilling to practice two acceptable methods of birth control.
* Do not plan to continue practicing two acceptable methods of birth control throughout the trial (highly effective methods of birth control are defined as those, used alone or in combination, that result in a low failure rate i.e. less than 1% per year when used consistently and correctly).
* Patients with mental and/or physical ailments which may prohibit them from actively participating in the study.
* Any health-related gadolinium/MRI contraindications (e.g. allergy to gadolinium, pacemakers, Implantable Cardioverter Defibrillators (ICD's), other devices/implants contraindicated for use of MRI, etc.)
* Patients who have a known terminal illness with a prognosis less than 12 months at the time of the informed consent process.
* Planned cardiovascular intervention.
* Patient with diagnosed acute or chronic severe kidney disease or with a low glomerular filtration rate (GFR), \<30 mL per minute per 1.73 m2
* Patients who cannot read, speak, and/or understand English.
* Patients with cognitive impairments who are unable to give informed consent.

Contacts and Locations

Study Contact

Quintrele Jones, MPH

CONTACT

504-988-3063

qjones1@tulane.edu

Principal Investigator

Nassir Marrouche, MD

PRINCIPAL_INVESTIGATOR

Tulane University

Study Locations (Sites)

Tulane University Medical Center

New Orleans, Louisiana, 70112

United States

Collaborators and Investigators

Sponsor: Tulane University

Nassir Marrouche, MD, PRINCIPAL_INVESTIGATOR, Tulane University

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 Registration Dates

Study Start Date2021-09-22

Study Completion Date2025-12

Study Record Updates

Study Start Date2021-09-22

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Catheter ablation
Coagulation
Atrial Fibrillation burden

Additional Relevant MeSH Terms

Atrial Fibrillation